Trial record 1 of 1 for:    RTOG 0848
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Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed By the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed By Surgery

This study is currently recruiting participants.
Verified October 2013 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01013649
First received: November 13, 2009
Last updated: April 9, 2014
Last verified: October 2013
  Purpose

This randomized phase II-R/III trial studies gemcitabine hydrochloride with or without erlotinib hydrochloride followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Giving chemotherapy together with or without erlotinib hydrochloride and/or radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective when given with or without erlotinib hydrochloride and/or radiation therapy in treating pancreatic cancer.


Condition Intervention Phase
Acinar Cell Adenocarcinoma of the Pancreas
Duct Cell Adenocarcinoma of the Pancreas
Intraductal Papillary Mucinous Neoplasm of the Pancreas
Stage IA Pancreatic Cancer
Stage IB Pancreatic Cancer
Stage IIA Pancreatic Cancer
Stage IIB Pancreatic Cancer
Drug: gemcitabine hydrochloride
Drug: erlotinib hydrochloride
Radiation: 3-dimensional conformal radiation therapy
Radiation: intensity-modulated radiation therapy
Drug: capecitabine
Drug: fluorouracil
Other: laboratory biomarker analysis
Other: quality-of-life assessment
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II-R and a Phase III Trial Evaluating Both *Erlotinib (PH II-R) and Chemoradiation (PH III) as Adjuvant Treatment For Patients With Resected Head of Pancreas Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival (Phase II) [ Time Frame: From the date of first randomization (gemcitabine vs. gemcitabine/erlotinib) to the date of death or last follow-up, assessed up to 11 years ] [ Designated as safety issue: No ]
    Overall survival will be estimated by the Kaplan-Meier method. The distribution of overall survival estimates between the two arms for both primary endpoint questions will be compared using the log rank test. The Cox proportional hazard regression model will be used to analyze the effects of factors, in addition to treatment, that may be associated with overall survival.

  • Overall survival (Phase III) [ Time Frame: From the date of second randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to the date of death or last follow-up, assessed up to 11 years ] [ Designated as safety issue: No ]
    Overall survival will be estimated by the Kaplan-Meier method. The distribution of overall survival estimates between the two arms for both primary endpoint questions will be compared using the log rank test. The Cox proportional hazard regression model will be used to analyze the effects of factors, in addition to treatment, that may be associated with overall survival.


Secondary Outcome Measures:
  • Disease-free survival [ Time Frame: Up to 11 years ] [ Designated as safety issue: No ]
    Disease-free survival will be estimated by the Kaplan-Meier method.

  • Incidence of adverse events assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 11 years ] [ Designated as safety issue: Yes ]
  • Frequency of objective criteria of resectability as measured by preoperative imaging [ Time Frame: Up to 11 years ] [ Designated as safety issue: No ]
  • Changes in fatigue as measured by the FACIT-F (primary) and the PROMIS derived short form (exploratory) [ Time Frame: Baseline up to 24 months ] [ Designated as safety issue: No ]
    The primary HRQoL hypothesis will be tested using the log-rank statistic with a significance level of 0.05. Additionally, analyses of fatigue effect will be performed using the Cox proportional hazard model.


Estimated Enrollment: 950
Study Start Date: November 2009
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (gemcitabine hydrochloride)
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity.
Drug: gemcitabine hydrochloride
Given IV
Other Names:
  • dFdC
  • difluorodeoxycytidine hydrochloride
  • gemcitabine
  • Gemzar
Other: laboratory biomarker analysis
Correlative studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Arm II (gemcitabine hydrochloride, erlotinib hydrochloride)
Patients receive gemcitabine hydrochloride as in arm I and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity.
Drug: gemcitabine hydrochloride
Given IV
Other Names:
  • dFdC
  • difluorodeoxycytidine hydrochloride
  • gemcitabine
  • Gemzar
Drug: erlotinib hydrochloride
Given PO
Other Names:
  • CP-358,774
  • erlotinib
  • OSI-774
Other: laboratory biomarker analysis
Correlative studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Arm III (chemotherapy)
Patients receive 1 course of the same treatment that they receive in arm I or II.
Drug: gemcitabine hydrochloride
Given IV
Other Names:
  • dFdC
  • difluorodeoxycytidine hydrochloride
  • gemcitabine
  • Gemzar
Drug: erlotinib hydrochloride
Given PO
Other Names:
  • CP-358,774
  • erlotinib
  • OSI-774
Other: laboratory biomarker analysis
Correlative studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Arm IV (chemotherapy, chemoradiotherapy)
Patients receive 1 course of the same treatment that they receive in arm I or II. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (3-dimensional conformal radiotherapy or intensity-modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO BID 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed.
Drug: gemcitabine hydrochloride
Given IV
Other Names:
  • dFdC
  • difluorodeoxycytidine hydrochloride
  • gemcitabine
  • Gemzar
Drug: erlotinib hydrochloride
Given PO
Other Names:
  • CP-358,774
  • erlotinib
  • OSI-774
Radiation: 3-dimensional conformal radiation therapy
Undergo 3-dimensional conformal radiation therapy
Other Names:
  • 3D conformal radiation therapy
  • 3D-CRT
Radiation: intensity-modulated radiation therapy
Undergo intensity-modulated radiation therapy
Other Name: IMRT
Drug: capecitabine
Given PO
Other Names:
  • CAPE
  • Ro 09-1978/000
  • Xeloda
Drug: fluorouracil
Given IV
Other Names:
  • 5-fluorouracil
  • 5-Fluracil
  • 5-FU
Other: laboratory biomarker analysis
Correlative studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection (i.e., removal of all gross tumor) involving a classic pancreaticoduodenectomy (Whipple) or a pylorus preserving pancreaticoduodenectomy; patients with invasive adenocarcinoma that also contains a component of intraductal papillary mucinous neoplasm (IPMN) are eligible

    • The operating surgeon must document in the operative note that a complete gross excision of the primary tumor was achieved; the pathology report must include documentation of the margin status and the size of the tumor; the pathology report must also include the status of the three major margins—bile duct, pancreatic parenchyma, and retroperitoneal (uncinate)
  • Interval between definitive tumor-related surgery and 1st step registration between 21-70 days
  • Patients will be staged according to the 6th edition American Joint Committee on Cancer (AJCC) staging system with pathologic stage T1-3, N0-1, M-0 being eligible
  • Zubrod performance status 0 or 1
  • Complete history and physical examination including weight and Zubrod status within 31 days of study entry
  • Before starting therapy the patient should be able to maintain adequate oral nutrition of >= 1500 calories estimated caloric intake per day and be free of significant nausea and vomiting
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelets >= 100,000/mm^3
  • Hemoglobin (Hgb) >= 8.0 g/dL (transfusion or other intervention to achieve Hgb >= 8.0 g/dl is acceptable)
  • Post resection serum cancer antigen (CA)19-9 =< 180 units/mL within 21 days of registration on study
  • Serum total bilirubin =< twice the institutional upper limit of normal (ULN) within 21 days of registration on study
  • Creatinine levels =< twice the institutional upper limit of normal within 21 days of registration on study
  • Serum glutamic oxaloacetic transaminase (SGOT) must be =< 2.5 x institutional ULN within 21 days of registration on study
  • Negative serum pregnancy test for women of childbearing potential within 14 days of study registration
  • Abdominal/pelvic computed tomography (CT) scan with contrast is preferred; abdominal CT alone is acceptable only if insurance restrictions are experienced; chest CT/x-ray (CT of chest preferred) within 31 days of registration on study; patients allergic to intravenous (IV) contrast can have magnetic resonance imaging (MRI) of the abdomen/pelvis instead
  • Signed study-specific informed consent
  • Consultation, agreement, and documentation in the patient's chart by a radiation oncologist that patient is suitable to receive radiotherapy per this protocol
  • Women of childbearing potential and male participants must practice adequate contraception
  • Patients with active human immunodeficiency virus (HIV) infection are eligible if their cluster of differentiation (CD)4 count is > 499/cu mm and their viral load is < 50 copies/ml; use of highly active antiretroviral treatment (HAART) is allowed

Exclusion Criteria:

  • Patients with non-adenocarcinomas, adenosquamous carcinomas, islet cell (neuroendocrine) tumors, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct, and ampullary carcinomas; patients with tumors that are largely IPMN with a minimal or minor component of invasive carcinoma are not eligible; patients with acinar carcinomas are not eligible; patients with IPMN's that contain some secondary (minor) foci of adenocarcinoma are also not eligible
  • Patients managed with a total pancreatectomy, a distal pancreatectomy, or central pancreatectomy
  • Prior systemic chemotherapy for pancreas cancer; note that prior chemotherapy for a different cancer is allowable
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Previous history of invasive malignancy (except non-melanoma skin cancer) unless the patient has been disease free for at least 2 years prior to study entry (patients with a previous history of carcinoma in situ are eligible)
  • Severe, active co-morbidity, defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    • Transmural myocardial infarction within the 3 months of study registration
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • Pregnant or lactating women
  • Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
  • If surgical margin status cannot be determined after consultation with the operating surgeon and the institutional pathologist, the patient will be ineligible
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013649

  Hide Study Locations
Locations
United States, Alabama
Providence Hospital Terminated
Mobile, Alabama, United States, 36608
United States, Arizona
Mayo Clinic in Arizona Withdrawn
Scottsdale, Arizona, United States, 85259
United States, California
Sutter Cancer Centers Radiation Oncology Services-Auburn Active, not recruiting
Auburn, California, United States, 95603
Roy and Patricia Disney Family Cancer Center Withdrawn
Burbank, California, United States, 91505
Providence Saint Joseph Medical Center/Disney Family Cancer Center Active, not recruiting
Burbank, California, United States, 91505
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Active, not recruiting
Cameron Park, California, United States, 95682
Mercy San Juan Medical Center Active, not recruiting
Carmichael, California, United States, 95608
City of Hope Medical Center Withdrawn
Duarte, California, United States, 91010
Saint Agnes Medical Center Active, not recruiting
Fresno, California, United States, 93720
California Cancer Center - North Fresno Active, not recruiting
Fresno, California, United States, 93720
Marin General Hospital Active, not recruiting
Greenbrae, California, United States, 94904
University of Southern California/Norris Cancer Center Active, not recruiting
Los Angeles, California, United States, 90033
Los Angeles County-USC Medical Center Active, not recruiting
Los Angeles, California, United States, 90033
Kaiser Permanente Oakland-Broadway Active, not recruiting
Oakland, California, United States, 94611
Bay Area Tumor Institute CCOP Active, not recruiting
Oakland, California, United States, 94609
Alta Bates Summit Medical Center - Summit Campus Active, not recruiting
Oakland, California, United States, 94609
University of California Medical Center At Irvine-Orange Campus Active, not recruiting
Orange, California, United States, 92868
Kaiser Permanente-Rancho Cordova Cancer Center Active, not recruiting
Rancho Cardova, California, United States, 95670
Rohnert Park Cancer Center Active, not recruiting
Rohnert Park, California, United States, 94928
The Permanente Medical Group-Roseville Radiation Oncology Active, not recruiting
Roseville, California, United States, 95678
Sutter Cancer Centers Radiation Oncology Services-Roseville Active, not recruiting
Roseville, California, United States, 95661
Radiological Associates of Sacramento Active, not recruiting
Sacramento, California, United States, 95815
South Sacramento Cancer Center Active, not recruiting
Sacramento, California, United States, 95823
Mercy General Hospital Radiation Oncology Center Terminated
Sacramento, California, United States, 95819
Saint Helena Hospital Withdrawn
Saint Helena, California, United States, 94574
University of California At San Diego Active, not recruiting
San Diego, California, United States, 92103
Sharp Memorial Hospital Active, not recruiting
San Diego, California, United States, 92123
California Pacific Medical Center Withdrawn
San Francisco, California, United States, 94118
Kaiser Permanente Medical Center - Santa Clara Active, not recruiting
Santa Clara, California, United States, 95051
Kaiser Permanente Radiation Oncology Cancer Treatment Center Withdrawn
Santa Clara, California, United States, 95051
Kaiser Permanente Cancer Treatment Center Active, not recruiting
South San Francisco, California, United States, 94080
Sutter Cancer Centers Radiation Oncology Services-Vacaville Active, not recruiting
Vacaville, California, United States, 95687
Sutter Solano Medical Center Withdrawn
Vallejo, California, United States, 94589
United States, Colorado
The Medical Center of Aurora Active, not recruiting
Aurora, Colorado, United States, 80012
Rocky Mountain Cancer Centers-Aurora Active, not recruiting
Aurora, Colorado, United States, 80012
Boulder Community Hospital Active, not recruiting
Boulder, Colorado, United States, 80301
Penrose-Saint Francis Healthcare Active, not recruiting
Colorado Springs, Colorado, United States, 80907
Rocky Mountain Cancer Centers-Penrose Active, not recruiting
Colorado Springs, Colorado, United States, 80907
Exempla Saint Joseph Hospital Active, not recruiting
Denver, Colorado, United States, 80218
Porter Adventist Hospital Active, not recruiting
Denver, Colorado, United States, 80210
Presbyterian - Saint Lukes Medical Center - Health One Active, not recruiting
Denver, Colorado, United States, 80218
Swedish Medical Center Active, not recruiting
Englewood, Colorado, United States, 80113
Saint Mary's Hospital and Regional Medical Center Terminated
Grand Junction, Colorado, United States, 81502
North Colorado Medical Center Active, not recruiting
Greeley, Colorado, United States, 80631
Rocky Mountain Cancer Centers-Littleton Active, not recruiting
Littleton, Colorado, United States, 80120
Sky Ridge Medical Center Active, not recruiting
Lone Tree, Colorado, United States, 80124
Longmont United Hospital Active, not recruiting
Longmont, Colorado, United States, 80501
McKee Medical Center Active, not recruiting
Loveland, Colorado, United States, 80539
Saint Mary Corwin Medical Center Active, not recruiting
Pueblo, Colorado, United States, 81004
Rocky Mountain Cancer Centers-Thornton Active, not recruiting
Thornton, Colorado, United States, 80260
North Suburban Medical Center Terminated
Thornton, Colorado, United States, 80229
Exempla Lutheran Medical Center Active, not recruiting
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Saint Vincent's Medical Center Active, not recruiting
Bridgeport, Connecticut, United States, 06606
Hartford Hospital Active, not recruiting
Hartford, Connecticut, United States, 06102
The Hospital of Central Connecticut Active, not recruiting
New Britain, Connecticut, United States, 06050
United States, Delaware
Christiana Care Health System-Christiana Hospital Active, not recruiting
Newark, Delaware, United States, 19718
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Active, not recruiting
Washington, District of Columbia, United States, 20057
Washington Hospital Center Withdrawn
Washington, District of Columbia, United States, 20010
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach Active, not recruiting
Deerfield Beach, Florida, United States, 33442
Holy Cross Hospital Active, not recruiting
Fort Lauderdale, Florida, United States, 33308
Mayo Clinic in Florida Active, not recruiting
Jacksonville, Florida, United States, 32224-9980
University of Miami Miller School of Medicine-Sylvester Cancer Center Active, not recruiting
Miami, Florida, United States, 33136
Mount Sinai Medical Center CCOP Active, not recruiting
Miami Beach, Florida, United States, 33140
UF Cancer Center at Orlando Health Active, not recruiting
Orlando, Florida, United States, 32806
Florida Hospital Active, not recruiting
Orlando, Florida, United States, 32803
Bay Medical Center Active, not recruiting
Panama City, Florida, United States, 32401
United States, Georgia
Grady Health System Active, not recruiting
Atlanta, Georgia, United States, 30303
Northeast Georgia Medical Center Active, not recruiting
Gainesville, Georgia, United States, 30501
Memorial Health University Medical Center Active, not recruiting
Savannah, Georgia, United States, 31403
Saint Joseph's-Candler Health System Active, not recruiting
Savannah, Georgia, United States, 31405
United States, Hawaii
Queen's Medical Center Active, not recruiting
Honolulu, Hawaii, United States, 96813
The Cancer Center of Hawaii-Liliha Active, not recruiting
Honolulu, Hawaii, United States, 96817
University of Hawaii Active, not recruiting
Honolulu, Hawaii, United States, 96813
United States, Idaho
Saint Luke's Mountain States Tumor Institute Active, not recruiting
Boise, Idaho, United States, 83712
Saint Luke's Mountain States Tumor Institute-Twin Falls Active, not recruiting
Twin Falls, Idaho, United States, 83301
United States, Illinois
Saint Anthony's Health Withdrawn
Alton, Illinois, United States, 62002
Northwest Community Hospital Terminated
Arlington Heights, Illinois, United States, 60005
Advocate Illinois Masonic Medical Center Active, not recruiting
Chicago, Illinois, United States, 60657
Rush University Medical Center Active, not recruiting
Chicago, Illinois, United States, 60612
John H Stroger Jr Hospital of Cook County Active, not recruiting
Chicago, Illinois, United States, 60612-3785
University of Illinois Active, not recruiting
Chicago, Illinois, United States, 60612
University of Chicago Active, not recruiting
Chicago, Illinois, United States, 60637
Northwestern University Active, not recruiting
Chicago, Illinois, United States, 60611
Ingalls Memorial Hospital Active, not recruiting
Harvey, Illinois, United States, 60426
Presence Saint Mary's Hospital Active, not recruiting
Kankakee, Illinois, United States, 60901
Loyola University Medical Center Active, not recruiting
Maywood, Illinois, United States, 60153
Edward Hospital/Cancer Center Active, not recruiting
Naperville, Illinois, United States, 60540
OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC Active, not recruiting
Peoria, Illinois, United States, 61615-7827
OSF Saint Francis Medical Center Active, not recruiting
Peoria, Illinois, United States, 61637
Saint Anthony Medical Center Withdrawn
Rockford, Illinois, United States, 61108
Saint John's Hospital Active, not recruiting
Springfield, Illinois, United States, 62702
Memorial Medical Center Active, not recruiting
Springfield, Illinois, United States, 62781-0001
Carle Cancer Center Active, not recruiting
Urbana, Illinois, United States, 61801
United States, Indiana
Saint Francis Hospital and Health Centers Withdrawn
Beech Grove, Indiana, United States, 46107
Elkhart General Hospital Active, not recruiting
Elkhart, Indiana, United States, 46515
IU Health Goshen Center for Cancer Care Active, not recruiting
Goshen, Indiana, United States, 46526
Reid Hospital and Health Care Services Withdrawn
Richmond, Indiana, United States, 47374
Memorial Hospital of South Bend Active, not recruiting
South Bend, Indiana, United States, 46601
Northern Indiana Cancer Research Consortium Active, not recruiting
South Bend, Indiana, United States, 46628
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center Active, not recruiting
Ames, Iowa, United States, 50010
Mercy Cancer Center-West Lakes Active, not recruiting
Clive, Iowa, United States, 50325
Medical Oncology and Hematology Associates-West Des Moines Active, not recruiting
Clive, Iowa, United States, 50325
Iowa Lutheran Hospital Active, not recruiting
Des Moines, Iowa, United States, 50316
Medical Oncology and Hematology Associates-Des Moines Active, not recruiting
Des Moines, Iowa, United States, 50309
Iowa Oncology Research Association CCOP Active, not recruiting
Des Moines, Iowa, United States, 50309
Iowa Methodist Medical Center Active, not recruiting
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Laurel Active, not recruiting
Des Moines, Iowa, United States, 50314
Mercy Medical Center - Des Moines Active, not recruiting
Des Moines, Iowa, United States, 50314
Siouxland Hematology Oncology Associates Active, not recruiting
Sioux City, Iowa, United States, 51101
United States, Kansas
Kansas City CCOP Active, not recruiting
Prairie Village, Kansas, United States, 66208
Stormont-Vail Regional Health Center Active, not recruiting
Topeka, Kansas, United States, 66604
Via Christi Regional Medical Center Active, not recruiting
Wichita, Kansas, United States, 67214
United States, Kentucky
Baptist Health Lexington Active, not recruiting
Lexington, Kentucky, United States, 40503
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Mahesh R. Kudrimoti    859-257-3379      
Principal Investigator: Mahesh R. Kudrimoti         
United States, Louisiana
Tulane University Health Sciences Center Active, not recruiting
New Orleans, Louisiana, United States, 70112
Ochsner Clinic CCOP Withdrawn
New Orleans, Louisiana, United States, 70121
Ochsner Medical Center Jefferson Active, not recruiting
New Orleans, Louisiana, United States, 70121
Louisiana State University Health Sciences Center Shreveport Active, not recruiting
Shreveport, Louisiana, United States, 71130
United States, Maryland
University of Maryland/Greenebaum Cancer Center Active, not recruiting
Baltimore, Maryland, United States, 21201
Saint Agnes Hospital Active, not recruiting
Baltimore, Maryland, United States, 21229
Sinai Hospital of Baltimore Active, not recruiting
Baltimore, Maryland, United States, 21215
Peninsula Regional Medical Center Active, not recruiting
Salisbury, Maryland, United States, 21801
United States, Massachusetts
Boston Medical Center Active, not recruiting
Boston, Massachusetts, United States, 02118
Brigham and Women's Hospital Active, not recruiting
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center Active, not recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan Active, not recruiting
Ann Arbor, Michigan, United States, 48109
Henry Ford Macomb Hospital Active, not recruiting
Clinton Township, Michigan, United States, 48038
Huron Valley-Sinai Hospital Active, not recruiting
Commerce, Michigan, United States, 48382
Henry Ford Hospital Active, not recruiting
Detroit, Michigan, United States, 48202
Wayne State University/Karmanos Cancer Institute Active, not recruiting
Detroit, Michigan, United States, 48201
Weisberg Cancer Treatment Center Active, not recruiting
Farmington Hills, Michigan, United States, 48334
Borgess Medical Center Active, not recruiting
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital Active, not recruiting
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center Active, not recruiting
Kalamazoo, Michigan, United States, 49007
United States, Minnesota
Unity Hospital Active, not recruiting
Fridley, Minnesota, United States, 55432
Minnesota Oncology Hematology PA-Maplewood Active, not recruiting
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital Active, not recruiting
Minneapolis, Minnesota, United States, 55407
Mayo Clinic Active, not recruiting
Rochester, Minnesota, United States, 55905
Regions Hospital Active, not recruiting
Saint Paul, Minnesota, United States, 55101
United Hospital Active, not recruiting
Saint Paul, Minnesota, United States, 55102
United States, Mississippi
University of Mississippi Medical Center Active, not recruiting
Jackson, Mississippi, United States, 39216
Singing River Hospital Active, not recruiting
Pascagoula, Mississippi, United States, 39581
United States, Missouri
Southeast Cancer Center Active, not recruiting
Cape Girardeau, Missouri, United States, 63703
Saint Francis Medical Center Withdrawn
Cape Girardeau, Missouri, United States, 63703
University of Missouri - Ellis Fischel Active, not recruiting
Columbia, Missouri, United States, 65212
Phelps County Regional Medical Center Active, not recruiting
Rolla, Missouri, United States, 65401
Missouri Baptist Medical Center Active, not recruiting
Saint Louis, Missouri, United States, 63131
Center for Cancer Care and Research Terminated
Saint Louis, Missouri, United States, 63141
Barnes-Jewish West County Hospital Active, not recruiting
Saint Louis, Missouri, United States, 63141
Washington University School of Medicine Active, not recruiting
Saint Louis, Missouri, United States, 63110
Saint John's Mercy Medical Center Active, not recruiting
Saint Louis, Missouri, United States, 63141
Saint Louis University Hospital Active, not recruiting
Saint Louis, Missouri, United States, 63110
Siteman Cancer Center-South County Active, not recruiting
Saint Louis, Missouri, United States, 63129
Saint Louis-Cape Girardeau CCOP Withdrawn
Saint Louis, Missouri, United States, 63141
Siteman Cancer Center - Saint Peters Active, not recruiting
Saint Peters, Missouri, United States, 63376
Mercy Hospital Springfield Active, not recruiting
Springfield, Missouri, United States, 65804
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield Active, not recruiting
Springfield, Missouri, United States, 65802
CoxHealth South Hospital Active, not recruiting
Springfield, Missouri, United States, 65807
United States, Montana
Montana Cancer Consortium CCOP Active, not recruiting
Billings, Montana, United States, 59101
Billings Clinic Active, not recruiting
Billings, Montana, United States, 59107-7000
Northern Rockies Radiation Oncology Center Terminated
Billings, Montana, United States, 59101
Bozeman Deaconess Cancer Center Terminated
Bozeman, Montana, United States, 59715
Great Falls Clinic Terminated
Great Falls, Montana, United States, 59405
Berdeaux, Donald MD (UIA Investigator) Terminated
Great Falls, Montana, United States, 59405
Kalispell Regional Medical Center Active, not recruiting
Kalispell, Montana, United States, 59901
United States, Nebraska
Good Samaritan Hospital Active, not recruiting
Kearney, Nebraska, United States, 68847
Nebraska Methodist Hospital Active, not recruiting
Omaha, Nebraska, United States, 68114
United States, Nevada
Comprehensive Cancer Centers of Nevada - Central Valley Active, not recruiting
Las Vegas, Nevada, United States, 89169
Nevada Cancer Research Foundation CCOP Active, not recruiting
Las Vegas, Nevada, United States, 89106
Renown Regional Medical Center Active, not recruiting
Reno, Nevada, United States, 89502
United States, New Hampshire
Elliot Hospital Active, not recruiting
Manchester, New Hampshire, United States, 03103
United States, New Jersey
Memorial Sloan Kettering Cancer Center at Basking Ridge Active, not recruiting
Basking Ridge, New Jersey, United States, 07920
Cooper Hospital University Medical Center Active, not recruiting
Camden, New Jersey, United States, 08103
Saint Barnabas Medical Center Active, not recruiting
Livingston, New Jersey, United States, 07039
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County Active, not recruiting
Mount Holly, New Jersey, United States, 08060
Newark Beth Israel Medical Center Active, not recruiting
Newark, New Jersey, United States, 07112
UMDNJ - New Jersey Medical School Active, not recruiting
Newark, New Jersey, United States, 07103
Valley Hospital Active, not recruiting
Ridgewood, New Jersey, United States, 07450
Sparta Cancer Treatment Center Active, not recruiting
Sparta, New Jersey, United States, 07871
Virtua West Jersey Hospital Voorhees Active, not recruiting
Voorhees, New Jersey, United States, 08043
United States, New York
New York Oncology Hematology PC - Albany Terminated
Albany, New York, United States, 12206
Maimonides Medical Center Active, not recruiting
Brooklyn, New York, United States, 11219
Sands Cancer Center Active, not recruiting
Canandiaqua, New York, United States, 14424
Memorial Sloan Kettering Cancer Center Commack Active, not recruiting
Commack, New York, United States, 11725
Glens Falls Hospital Active, not recruiting
Glens Falls, New York, United States, 12801
North Shore-LIJ Health System CCOP Withdrawn
Manhasset, New York, United States, 11030
Orange Regional Medical Center Active, not recruiting
Middletown, New York, United States, 10940
Long Island Jewish Medical Center Withdrawn
New Hyde Park, New York, United States, 11040
Memorial Sloan-Kettering Cancer Center Active, not recruiting
New York, New York, United States, 10065
New York University Langone Medical Center Active, not recruiting
New York, New York, United States, 10016
Highland Hospital Active, not recruiting
Rochester, New York, United States, 14620
University Radiation Oncology Active, not recruiting
Rochester, New York, United States, 14626
University of Rochester Active, not recruiting
Rochester, New York, United States, 14642
Memorial Sloan-Kettering Cancer Center Rockville Centre Active, not recruiting
Rockville Centre, New York, United States, 11570
Memorial Sloan-Kettering Cancer Center at Sleepy Hallow Active, not recruiting
Sleepy Hollow, New York, United States, 10591
United States, North Carolina
Carolinas Medical Center Active, not recruiting
Charlotte, North Carolina, United States, 28203
Novant Health Presbyterian Medical Center Active, not recruiting
Charlotte, North Carolina, United States, 28204
CMC-LCI Radiation Therapy-Pineville Active, not recruiting
Charlotte, North Carolina, United States, 28210
Carolinas Medical Center - Northeast Active, not recruiting
Concord, North Carolina, United States, 28025
East Carolina University Active, not recruiting
Greenville, North Carolina, United States, 27858
Kinston Medical Specialists PA Active, not recruiting
Kinston, North Carolina, United States, 28501
Rex Cancer Center Active, not recruiting
Raleigh, North Carolina, United States, 27607
Rutherford Hospital Terminated
Rutherfordton, North Carolina, United States, 28139
United States, Ohio
Akron General Medical Center Active, not recruiting
Akron, Ohio, United States, 44307
Summa Akron City Hospital/Cooper Cancer Center Active, not recruiting
Akron, Ohio, United States, 44304
Radiation Oncology Center Terminated
Alliance, Ohio, United States, 44601
Summa Barberton Hospital Active, not recruiting
Barberton, Ohio, United States, 44203
Adena Regional Medical Center Active, not recruiting
Chillicothe, Ohio, United States, 45601
University of Cincinnati Active, not recruiting
Cincinnati, Ohio, United States, 45267
MetroHealth Medical Center Active, not recruiting
Cleveland, Ohio, United States, 44109
Columbus CCOP Active, not recruiting
Columbus, Ohio, United States, 43215
Grant Medical Center Active, not recruiting
Columbus, Ohio, United States, 43215
Doctors Hospital Active, not recruiting
Columbus, Ohio, United States, 43228
Riverside Methodist Hospital Active, not recruiting
Columbus, Ohio, United States, 43214
The Mark H Zangmeister Center Active, not recruiting
Columbus, Ohio, United States, 43219
Mount Carmel Health Center West Active, not recruiting
Columbus, Ohio, United States, 43222
Grandview Hospital Withdrawn
Dayton, Ohio, United States, 45405
Good Samaritan Hospital - Dayton Withdrawn
Dayton, Ohio, United States, 45406
Miami Valley Hospital Withdrawn
Dayton, Ohio, United States, 45409
Samaritan North Health Center Withdrawn
Dayton, Ohio, United States, 45415
Dayton CCOP Withdrawn
Dayton, Ohio, United States, 45420
Grady Memorial Hospital Active, not recruiting
Delaware, Ohio, United States, 43015
Community Health Partners Regional Medical Center Terminated
Elyria, Ohio, United States, 44035
Blanchard Valley Hospital Withdrawn
Findlay, Ohio, United States, 45840
Atrium Medical Center-Middletown Regional Hospital Withdrawn
Franklin, Ohio, United States, 45005-1066
Kettering Medical Center Withdrawn
Kettering, Ohio, United States, 45429
Marietta Memorial Hospital Active, not recruiting
Marietta, Ohio, United States, 45750
Toledo Clinic Cancer Centers-Maumee Active, not recruiting
Maumee, Ohio, United States, 43537
Summa Health Center at Lake Medina Active, not recruiting
Medina, Ohio, United States, 44256
Licking Memorial Hospital Active, not recruiting
Newark, Ohio, United States, 43055
Robinson Radiation Oncology Active, not recruiting
Ravenna, Ohio, United States, 44266
Cancer Care Center, Incorporated Terminated
Salem, Ohio, United States, 44460
North Coast Cancer Care Active, not recruiting
Sandusky, Ohio, United States, 44870
Flower Hospital Active, not recruiting
Sylvania, Ohio, United States, 43560
University of Toledo Active, not recruiting
Toledo, Ohio, United States, 43614
Upper Valley Medical Center Withdrawn
Troy, Ohio, United States, 45373
University Pointe Active, not recruiting
West Chester, Ohio, United States, 45069
Saint Ann's Hospital Active, not recruiting
Westerville, Ohio, United States, 43081
Cancer Treatment Center Terminated
Wooster, Ohio, United States, 44691
Greene Memorial Hospital Withdrawn
Xenia, Ohio, United States, 45385
United States, Oklahoma
University of Oklahoma Health Sciences Center Active, not recruiting
Oklahoma City, Oklahoma, United States, 73104
Natalie Warren Bryant Cancer Center at Saint Francis Withdrawn
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Clackamas Radiation Oncology Center Active, not recruiting
Clackamas, Oregon, United States, 97015
Legacy Mount Hood Medical Center Active, not recruiting
Gresham, Oregon, United States, 97030
Legacy Good Samaritan Hospital and Medical Center Active, not recruiting
Portland, Oregon, United States, 97210
Western Oncology Research Consortium Active, not recruiting
Portland, Oregon, United States, 97213
Providence Portland Medical Center Active, not recruiting
Portland, Oregon, United States, 97213
Providence Saint Vincent Medical Center Active, not recruiting
Portland, Oregon, United States, 97225
Mid-Columbia Medical Center Active, not recruiting
The Dalles, Oregon, United States, 97058
United States, Pennsylvania
Abington Memorial Hospital Active, not recruiting
Abington, Pennsylvania, United States, 19001
Bryn Mawr Hospital Active, not recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Geisinger Medical Center Active, not recruiting
Danville, Pennsylvania, United States, 17822-2001
Delaware County Memorial Hospital Active, not recruiting
Drexel Hill, Pennsylvania, United States, 19026
Northeast Radiation Oncology Center Active, not recruiting
Dunmore, Pennsylvania, United States, 18512
Easton Hospital Active, not recruiting
Easton, Pennsylvania, United States, 18042
Adams Cancer Center Active, not recruiting
Gettysburg, Pennsylvania, United States, 17325
Cherry Tree Cancer Center Active, not recruiting
Hanover, Pennsylvania, United States, 17331
Riddle Hospital Active, not recruiting
Media, Pennsylvania, United States, 19063
Alle-Kiski Medical Center Active, not recruiting
Natrona Heights, Pennsylvania, United States, 15065
Paoli Memorial Hospital Active, not recruiting
Paoli, Pennsylvania, United States, 19301
Thomas Jefferson University Hospital Active, not recruiting
Philadelphia, Pennsylvania, United States, 19107
Aria Health-Torresdale Campus Active, not recruiting
Philadelphia, Pennsylvania, United States, 19114
Albert Einstein Medical Center Active, not recruiting
Philadelphia, Pennsylvania, United States, 19141
Pennsylvania Hospital Active, not recruiting
Philadelphia, Pennsylvania, United States, 19107
Reading Hospital Active, not recruiting
West Reading, Pennsylvania, United States, 19611
Lankenau Hospital Active, not recruiting
Wynnewood, Pennsylvania, United States, 19096
Mainline Health CCOP Active, not recruiting
Wynnewood, Pennsylvania, United States, 19096
WellSpan Health-York Hospital Active, not recruiting
York, Pennsylvania, United States, 17405
United States, Rhode Island
Radiation Oncology Associates Incorporated Active, not recruiting
Providence, Rhode Island, United States, 02904
Rhode Island Hospital Active, not recruiting
Providence, Rhode Island, United States, 02903
United States, South Carolina
AnMed Health Cancer Center Active, not recruiting
Anderson, South Carolina, United States, 29621
Medical University of South Carolina Active, not recruiting
Charleston, South Carolina, United States, 29425
Greenville Health System Cancer Institute-Faris Active, not recruiting
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Instutite/Greenville CCOP Active, not recruiting
Greenville, South Carolina, United States, 29615
Gibbs Cancer Center-Pelham Active, not recruiting
Greer, South Carolina, United States, 29651
Greenville Health System Cancer Institute-Greer Active, not recruiting
Greer, South Carolina, United States, 29650
Greenville Health System Cancer Institute-Seneca Active, not recruiting
Seneca, South Carolina, United States, 29672
Spartanburg Regional Medical Center Active, not recruiting
Spartanburg, South Carolina, United States, 29303
Upstate Carolina CCOP Active, not recruiting
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Rapid City Regional Hospital Active, not recruiting
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Vanderbilt-Ingram Cancer Center Active, not recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
The Don and Sybil Harrington Cancer Center Withdrawn
Amarillo, Texas, United States, 79106
Texas Oncology-Arlington South Active, not recruiting
Arlington, Texas, United States, 76014
Texas Oncology - South Austin Cancer Center Active, not recruiting
Austin, Texas, United States, 78745
Texas Oncology - Central Austin Cancer Center Active, not recruiting
Austin, Texas, United States, 78731
Texas Oncology-Austin Midtown Active, not recruiting
Austin, Texas, United States, 78705
Texas Oncology PA - Bedford Active, not recruiting
Bedford, Texas, United States, 76022
The Klabzuba Cancer Center Active, not recruiting
Fort Worth, Texas, United States, 76104
University of Texas Medical Branch at Galveston Active, not recruiting
Galveston, Texas, United States, 77555-0565
M D Anderson Cancer Center Withdrawn
Houston, Texas, United States, 77030
UTMB Cancer Center at Victory Lakes Terminated
League City, Texas, United States, 77573
Texas Oncology - Lewisville Terminated
Lewisville, Texas, United States, 75067
Texas Oncology-Longview Cancer Center Active, not recruiting
Longview, Texas, United States, 75601
Texas Oncology-Seton Williamson Active, not recruiting
Round Rock, Texas, United States, 78665
Texas Oncology - Round Rock Cancer Center Active, not recruiting
Round Rock, Texas, United States, 78681
Cancer Care Centers of South Texas- Northeast Active, not recruiting
San Antonio, Texas, United States, 78217
Texas Cancer Center-Sherman Active, not recruiting
Sherman, Texas, United States, 75090
Texas Oncology Cancer Center Sugar Land Active, not recruiting
Sugar Land, Texas, United States, 77479
Tyler Cancer Center Active, not recruiting
Tyler, Texas, United States, 75702
United States, Utah
Sandra L Maxwell Cancer Center Active, not recruiting
Cedar City, Utah, United States, 84720
Logan Regional Hospital Active, not recruiting
Logan, Utah, United States, 84321
Intermountain Medical Center Active, not recruiting
Murray, Utah, United States, 84157
McKay-Dee Hospital Center Active, not recruiting
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center Active, not recruiting
Provo, Utah, United States, 84604-3337
Dixie Medical Center Regional Cancer Center Active, not recruiting
Saint George, Utah, United States, 84770
Huntsman Cancer Institute/University of Utah Active, not recruiting
Salt Lake City, Utah, United States, 84112
LDS Hospital Active, not recruiting
Salt Lake City, Utah, United States, 84143
Utah Cancer Specialists-Salt Lake City Active, not recruiting
Salt Lake City, Utah, United States, 84106
United States, Virginia
Sentara Cancer Institute at Sentara CarePlex Hospital Active, not recruiting
Hampton, Virginia, United States, 23666
Sentara Hospitals Active, not recruiting
Norfolk, Virginia, United States, 23507
Sentara Virginia Beach General Hospital Active, not recruiting
Virginia Beach, Virginia, United States, 23454
United States, Washington
Saint Francis Hospital Active, not recruiting
Federal Way, Washington, United States, 98003
Good Samaritan Community Hospital Active, not recruiting
Puyallup, Washington, United States, 98372
Cancer Care Northwest-North Spokane Active, not recruiting
Spokane, Washington, United States, 99218
Cancer Care Northwest - Spokane South Active, not recruiting
Spokane, Washington, United States, 99202
Multicare Health System Active, not recruiting
Tacoma, Washington, United States, 98415
Northwest CCOP Active, not recruiting
Tacoma, Washington, United States, 98405
Saint Joseph Medical Center Active, not recruiting
Tacoma, Washington, United States, 98405
Legacy Salmon Creek Hospital Active, not recruiting
Vancouver, Washington, United States, 98686
PeaceHealth Southwest Medical Center Active, not recruiting
Vancouver, Washington, United States, 98664
Compass Oncology Vancouver Active, not recruiting
Vancouver, Washington, United States, 98684
United States, West Virginia
West Virginia University Charleston Active, not recruiting
Charleston, West Virginia, United States, 25304
Wheeling Hospital Active, not recruiting
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Langlade Hospital and Cancer Center Active, not recruiting
Antigo, Wisconsin, United States, 54409
Bellin Memorial Hospital Withdrawn
Green Bay, Wisconsin, United States, 54301
Saint Vincent Hospital Active, not recruiting
Green Bay, Wisconsin, United States, 54301
Saint Mary's Hospital Active, not recruiting
Green Bay, Wisconsin, United States, 54303
Gundersen Lutheran Active, not recruiting
La Crosse, Wisconsin, United States, 54601
Bay Area Medical Center Active, not recruiting
Marinette, Wisconsin, United States, 54143
Saint Joseph's Hospital Active, not recruiting
Marshfield, Wisconsin, United States, 54449
Froedtert and the Medical College of Wisconsin Active, not recruiting
Milwaukee, Wisconsin, United States, 53226
Marshfield Clinic-Minocqua Center Active, not recruiting
Minocqua, Wisconsin, United States, 54548
Saint Michael's Hospital Active, not recruiting
Stevens Point, Wisconsin, United States, 54481
Door County Cancer Center Active, not recruiting
Sturgeon Bay, Wisconsin, United States, 54235-1495
Aspirus Regional Cancer Center Active, not recruiting
Wausau, Wisconsin, United States, 54401
United States, Wyoming
Welch Cancer Center Active, not recruiting
Sheridan, Wyoming, United States, 82801
Belgium
University Hospital Saint Luc Active, not recruiting
Brussels, Belgium, 1200
Hospital Univ. Erasme Active, not recruiting
Brussels, Belgium, 1070
Algemeen Ziekenhuis Groeninge Campus Kennedylaan Active, not recruiting
Kortrijk, Belgium, 8500
AZ Turnhout-Campus Saint Elizabeth Active, not recruiting
Turnhout, Belgium, 2300
Canada, Ontario
London Regional Cancer Program Active, not recruiting
London, Ontario, Canada, N6A 4L6
Ottawa Health Research Institute-General Division Active, not recruiting
Ottawa, Ontario, Canada, K1H 1C4
The Ottawa Hospital Cancer Centre (Ottawa Health Research Institute) Civic Campus Withdrawn
Ottawa, Ontario, Canada, K1Y 4E9
Canada, Quebec
CHUM - Hopital Notre-Dame Withdrawn
Montreal, Quebec, Canada, H2L 4M1
McGill University Department of Oncology Withdrawn
Montreal, Quebec, Canada, H2W 1S6
Israel
Rabin Medical Center Active, not recruiting
Petach Tikva, Israel, 49100
Tel Aviv Sourasky Medical Center Active, not recruiting
Tel Aviv, Israel, 64239
Chaim Sheba Medical Center Active, not recruiting
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Investigators
Principal Investigator: Ross Abrams Radiation Therapy Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01013649     History of Changes
Other Study ID Numbers: NCI-2011-01987, NCI-2011-01987, RTOG-0848, CDR0000659092, RTOG 0848, RTOG-0848, U10CA021661, U10CA180868
Study First Received: November 13, 2009
Last Updated: April 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Neoplasms
Pancreatic Neoplasms
Carcinoma, Acinar Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Fluorouracil
Gemcitabine
Capecitabine
Erlotinib
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on April 23, 2014