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Standard Versus Intensity-Modulated Pelvic Radiation Therapy in Treating Patients With Endometrial or Cervical Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Radiation Therapy Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT01672892
First received: August 23, 2012
Last updated: October 27, 2014
Last verified: October 2014
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This randomized phase III trial is studying two different methods of radiation and their side effects and comparing how well they work in treating endometrial and cervical cancer after surgery.


Condition Intervention Phase
Cervical Cancer
Endometrial Cancer
Gastrointestinal Complications
Perioperative/Postoperative Complications
Radiation Toxicity
Urinary Complications
Urinary Tract Toxicity
Radiation: 3-dimensional conformal radiation therapy
Radiation: intensity-modulated radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study of Standard vs. IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical Cancer (TIME-C)

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Acute gastrointestinal toxicity, as measured by bowel domain of EPIC, at 5 weeks from the start of pelvic radiation [ Time Frame: Week 5 of Radiation Therapy (RT) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Validation of EPIC Bowel and Urinary domains [ Time Frame: Before study start, Week 3 of RT, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT ] [ Designated as safety issue: No ]
  • Toxicity, as measured by CTCAE v. 4.0 [ Time Frame: Before study start, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT ] [ Designated as safety issue: Yes ]
  • Urinary toxicity, as measured by EPIC urinary domain [ Time Frame: Before study start, Week 3 of RT, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT ] [ Designated as safety issue: Yes ]
  • Quality of life, as measured by the FACT-G with cervix subscale [ Time Frame: Before study start, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT ] [ Designated as safety issue: No ]
  • Health utilities, as measured by EQ-5D [ Time Frame: Before study start, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT ] [ Designated as safety issue: No ]
  • Local-regional control [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • Identification of molecular predictors of radiation toxicity and novel circulating cancer biomarkers [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Estimated Enrollment: 281
Study Start Date: November 2012
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients undergo standard (3-dimensional) radiation therapy 5 days a week for up to 5.5 weeks.
Radiation: 3-dimensional conformal radiation therapy
Undergo radiation therapy
Experimental: Arm II
Patients undergo intensity-modulated radiation therapy (IMRT) 5 days a week for up to 5.5 weeks.
Radiation: intensity-modulated radiation therapy
Undergo radiation therapy

Detailed Description:

OBJECTIVES:

Primary

  • To determine if pelvic intensity-modulated radiation therapy (IMRT) reduces acute gastrointestinal toxicity in the 5th week (after 23-25 fractions) of pelvic radiation as measured with the expanded prostate cancer index composite (EPIC) instrument.

Secondary

  • To determine if grade 2+ gastrointestinal toxicity (Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v. 4.0]) is reduced with IMRT compared to conventional whole-pelvis radiation therapy (WPRT).
  • To determine if grade 2+ hematologic toxicity (CTCAE v. 4.0) is reduced with IMRT compared to conventional WPRT.
  • To determine if urinary toxicity is reduced with IMRT using the EPIC urinary domain.
  • To validate EPIC bowel and urinary domains in women undergoing either IMRT pelvic radiation treatment or four-field pelvic radiation treatment for endometrial or cervical cancer.
  • To assess the impact of pelvic IMRT on quality of life using the Functional Assessment of Cancer Therapy-General (FACT-G) with cervix subscale.
  • To determine if there is any difference in local-regional control, disease-free survival, and overall survival between patients treated with IMRT as compared to conventional WPRT.
  • To perform a health-utilities analysis to measure the financial impact of pelvic IMRT via the EQ-5D instrument.
  • To identify molecular predictors of radiation toxicity and novel circulating cancer biomarkers.

OUTLINE: This is a multicenter study. Patients are stratified according to type of cancer (endometrial vs cervical), chemotherapy (none vs 5 courses of weekly cisplatin at 40 mg/m²), and radiation dose (45 Gy vs 50.4 Gy). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo standard (3-dimensional) radiation therapy 5 days a week for up to 5-6 weeks.
  • Arm II: Patients undergo intensity-modulated radiation therapy (IMRT) 5 days a week for up to 5-6 weeks.

Some patients receive cisplatin IV over 1 hour on day 1. Treatment continues weekly for 5 weeks, concurrently with radiation therapy, in the absence of unacceptable toxicity or disease progression.

Tissue and blood samples may be collected for biomarker and correlative analysis.

Quality of life may be assessed by questionnaires (including the Expanded Prostate Cancer Index Composite [EPIC], the Functional Assessment of Cancer Therapy-General [FACT-G, Version 4], the EQ-5D, and the Common Toxicity Criteria Adverse Events - Patient-Reported Outcome [PRO-CTCAE]) instruments at baseline and periodically during and after study therapy.

After completion of study therapy, patients are followed every 6 months for the first 2 years and then annually for 5 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Pathologically proven diagnosis of endometrial or cervical cancer
  • Patients must have undergone a hysterectomy (total abdominal hysterectomy, vaginal hysterectomy or radical hysterectomy, or total laparoscopic hysterectomy) for carcinoma of the cervix or endometrium within 49 days prior to registration

    • Performance of a bilateral salpingo-oophorectomy will be at the treating surgeon's discretion
    • No positive or close (< 3 mm) resection margins
  • Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:

    • History/physical examination within 45 days prior to registration
    • Computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET)-CT including the abdomen and pelvis should be performed for initial radiological staging (performed pre- or post-surgery within 90 days prior to registration)

      • Imaging performed postoperatively should show no evidence of residual disease
      • Any evidence of malignancy identified on preoperative imaging should have been completely resected surgically prior to protocol treatment
    • Chest x-ray or chest CT must be performed within 90 days prior to registration (unless a PET-CT has been performed)
  • Endometrial cancer:

    • Patients with the following histologic features are eligible for pelvic radiation therapy without weekly cisplatin:

      • Less than 50% myometrial invasion, grade 3 adenocarcinoma without uterine serous carcinoma (USC), or clear cell histology
      • At least 50% myometrial invasion, grade 1-2 adenocarcinoma without USC, or clear cell histology
    • Patients with the following histologic features may be treated with pelvic radiation with or without weekly cisplatin (the decision to add weekly cisplatin for these patients is at the treating physician's discretion):

      • At least 50% myometrial invasion, grade 3 including USC and clear cell carcinoma
      • International Federation of Gynecology and Obstetrics (FIGO) 2009 stage II endometrial cancer of any grade including USC and clear cell carcinoma
      • FIGO 2009 stage IIIC1 (pelvic lymph node positive only, para-aortic nodes negative if removed) including USC and clear cell carcinoma. NOTE: If para-aortic nodes are not removed, CT abdomen or PET must demonstrate no evidence of lymphadenopathy.
  • Cervical cancer:

    • Patients with the following pathology findings may be treated with pelvic radiation with or without weekly cisplatin at the treating physician's discretion:

      • Patients with intermediate-risk features including two of the following histologic findings after radical hysterectomy: 1/3 or more stromal invasion, lymph-vascular space invasion or large clinical tumor diameter (> 4 cm)
      • Patients with cervical cancer treated with a simple hysterectomy with negative margins
    • Patients with any of the following criteria following radical hysterectomy are eligible for this study and must receive weekly cisplatin:

      • Positive resected pelvic nodes and para-aortic nodes negative if removed. NOTE: If para-aortic nodes are not removed, CT abdomen or PET CT must demonstrate no evidence of lymphadenopathy.
      • Microscopic parametrial invasion with negative margins
  • No patients with para-aortic nodal disease or who require extended-field radiotherapy beyond the pelvis
  • No patients with histology consisting of endometrial stromal sarcoma, leiomyosarcoma, malignant mixed mullerian tumor (MMMT), or carcinosarcoma
  • No evidence of metastatic disease outside of the pelvis

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-2
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm³
  • Platelets ≥ 100,000 cells/mm³
  • Hemoglobin (Hgb) ≥ 8.0 g/dL (the use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable)
  • For patients receiving chemotherapy:

    • Within 14 days prior to registration, serum creatinine ≤ 1.5 mg/dL AND calculated creatinine clearance ≥ 50 mL/min
    • Aspartate aminotransferase (AST) ≤ 2 times upper limit of normal (ULN)
    • Bilirubin ≤ 2 times ULN
    • Alkaline phosphatase, magnesium, blood urea nitrogen (BUN), and electrolytes must be obtained and recorded
  • Fertile patients must use effective contraception
  • Not pregnant and/or breastfeeding
  • Willing and able to complete the bowel and urinary domains of the expanded prostate cancer index composite (EPIC) instrument prior to registration
  • No patients who exceed the weight/size limits of the treatment table or CT scanner
  • No mental status changes or bladder control problems that make the patient unable to comply with bladder-filling instructions
  • No prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 3 years
  • No patients with active inflammatory bowel disease
  • No 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 last 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Other major medical illness that requires hospitalization or precludes study therapy at the time of registration
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects (however, laboratory test coagulation parameters are not required for entry into this protocol)
    • Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition (however, human immunodeficiency virus [HIV] testing is not required for entry into this protocol)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior radiation therapy to the pelvis
  • No prior treatment with platinum-based chemotherapy
  • Patients may NOT receive amifostine or other protective reagents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672892

  Hide Study Locations
Locations
United States, Arizona
Banner MD Anderson Cancer Center Recruiting
Gilbert, Arizona, United States, 85234
Contact: Emily J. Grade    602-747-9738      
Principal Investigator: Emily J. Grade         
Arizona Oncology-Deer Valley Center Recruiting
Phoenix, Arizona, United States, 85027
Contact: David G. Brachman    800-360-6371      
Principal Investigator: David G. Brachman         
Arizona Oncology Services Foundation Recruiting
Scottsdale, Arizona, United States, 85260
Contact: David G. Brachman    800-360-6371      
Principal Investigator: David G. Brachman         
United States, California
California Cancer Center - North Fresno Recruiting
Fresno, California, United States, 93720
Contact: Uma G. Swamy    559-447-4050      
Principal Investigator: Uma G. Swamy         
UC San Diego Moores Cancer Center Active, not recruiting
La Jolla, California, United States, 92093
Kaiser Permanente Oakland-Broadway Recruiting
Oakland, California, United States, 94611
Contact: Samantha A. Seaward    626-564-3455      
Principal Investigator: Samantha A. Seaward         
Saint Joseph Hospital - Orange Recruiting
Orange, California, United States, 92868
Contact: Venita L. Williams    714-734-6220      
Principal Investigator: Venita L. Williams         
Feather River Cancer Center Recruiting
Paradise, California, United States, 95969
Contact: Sam Mazj    530-876-7995    haleew@ah.org   
Principal Investigator: Sam Mazj         
Pomona Valley Hospital Medical Center Recruiting
Pomona, California, United States, 91767
Contact: Yallapragada S. Rao    909-865-9555      
Principal Investigator: Yallapragada S. Rao         
Kaiser Permanente-Rancho Cordova Cancer Center Recruiting
Rancho Cardova, California, United States, 95670
Contact: Samantha A. Seaward    626-564-3455      
Principal Investigator: Samantha A. Seaward         
Rohnert Park Cancer Center Recruiting
Rohnert Park, California, United States, 94928
Contact: Samantha A. Seaward    626-564-3455      
Principal Investigator: Samantha A. Seaward         
The Permanente Medical Group-Roseville Radiation Oncology Recruiting
Roseville, California, United States, 95678
Contact: Samantha A. Seaward    626-564-3455      
Principal Investigator: Samantha A. Seaward         
South Sacramento Cancer Center Recruiting
Sacramento, California, United States, 95823
Contact: Samantha A. Seaward    626-564-3455      
Principal Investigator: Samantha A. Seaward         
University of California at Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Jyoti S. Mayadev    916-734-3089      
Principal Investigator: Jyoti S. Mayadev         
Kaiser Permanente Medical Center - Santa Clara Recruiting
Santa Clara, California, United States, 95051
Contact: Samantha A. Seaward    626-564-3455      
Principal Investigator: Samantha A. Seaward         
Kaiser Permanente Cancer Treatment Center Recruiting
South San Francisco, California, United States, 94080
Contact: Samantha A. Seaward    626-564-3455      
Principal Investigator: Samantha A. Seaward         
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion Active, not recruiting
Aurora, Colorado, United States, 80045
Penrose-Saint Francis Healthcare Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Keren Sturtz    888-785-6789      
Principal Investigator: Keren Sturtz         
Porter Adventist Hospital Recruiting
Denver, Colorado, United States, 80210
Contact: Keren Sturtz    888-785-6789      
Principal Investigator: Keren Sturtz         
Swedish Medical Center Recruiting
Englewood, Colorado, United States, 80113
Contact: Keren Sturtz    888-785-6789      
Principal Investigator: Keren Sturtz         
Rocky Mountain Cancer Centers-Littleton Recruiting
Littleton, Colorado, United States, 80120
Contact: Keren Sturtz    888-785-6789      
Principal Investigator: Keren Sturtz         
Longmont United Hospital Recruiting
Longmont, Colorado, United States, 80501
Contact: Keren Sturtz    888-785-6789      
Principal Investigator: Keren Sturtz         
McKee Medical Center Recruiting
Loveland, Colorado, United States, 80539
Contact: Keren Sturtz    888-785-6789      
Principal Investigator: Keren Sturtz         
United States, Delaware
Christiana Care Health System-Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Adam Raben    302-733-6227      
Principal Investigator: Adam Raben         
Beebe Health Campus Recruiting
Rehoboth Beach, Delaware, United States, 19971
Contact: Adam Raben    302-733-6227      
Principal Investigator: Adam Raben         
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Adedamola (Mola) B. Omogbehin    202-877-8839      
Principal Investigator: Adedamola (Mola) B. Omogbehin         
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Anamaria R. Yeung    352-273-8675    trials@cancer.ufl.edu   
Principal Investigator: Anamaria R. Yeung         
University of Florida Health Science Center Recruiting
Jacksonville, Florida, United States, 32209
Contact: Anamaria R. Yeung    352-273-8675    trials@cancer.ufl.edu   
Principal Investigator: Anamaria R. Yeung         
Jackson Memorial Hospital-Holtz Children's Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Lorraine Portelance    866-574-5124    Sylvester@emergingmed.com   
Principal Investigator: Lorraine Portelance         
University of Miami Miller School of Medicine-Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Lorraine Portelance    866-574-5124    Sylvester@emergingmed.com   
Principal Investigator: Lorraine Portelance         
United States, Georgia
Emory University/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Joseph W. Shelton    404-489-9164      
Principal Investigator: Joseph W. Shelton         
Grady Health System Recruiting
Atlanta, Georgia, United States, 30303
Contact: Joseph W. Shelton    404-489-9164      
Principal Investigator: Joseph W. Shelton         
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Sahar E. Rosenbaum    404-303-3355      
Principal Investigator: Sahar E. Rosenbaum         
Piedmont Hospital Recruiting
Atlanta, Georgia, United States, 30309
Contact: Adam W. Nowlan    404-425-7943    ORS@piedmont.org   
Principal Investigator: Adam W. Nowlan         
Northside Hospital-Forsyth Recruiting
Cumming, Georgia, United States, 30041
Contact: Sahar E. Rosenbaum    404-303-3355      
Principal Investigator: Sahar E. Rosenbaum         
Northeast Georgia Medical Center Recruiting
Gainesville, Georgia, United States, 30501
Contact: Frank G. Lake    770-219-8800    cancerpatient.navigator@nghs.com   
Principal Investigator: Frank G. Lake         
Saint Joseph's-Candler Health System Recruiting
Savannah, Georgia, United States, 31405
Contact: John A. Pablo    912-819-5704      
Principal Investigator: John A. Pablo         
United States, Hawaii
Leeward Radiation Oncology Center Recruiting
Ewa Beach, Hawaii, United States, 96706
Contact: Paul A. DeMare    808-545-8548      
Principal Investigator: Paul A. DeMare         
Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Paul A. DeMare    808-545-8548      
Principal Investigator: Paul A. DeMare         
The Cancer Center of Hawaii-Liliha Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Paul A. DeMare    808-545-8548      
Principal Investigator: Paul A. DeMare         
University of Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Paul A. DeMare    808-545-8548      
Principal Investigator: Paul A. DeMare         
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise Recruiting
Boise, Idaho, United States, 83706
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
United States, Illinois
Advocate Illinois Masonic Medical Center Recruiting
Chicago, Illinois, United States, 60657
Contact: Paige L. Dorn    773-296-5360      
Principal Investigator: Paige L. Dorn         
John H Stroger Jr Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612-3785
Contact: Anu Thakrar    312-864-6000      
Principal Investigator: Anu Thakrar         
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Eric D. Donnelly    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Eric D. Donnelly         
University of Illinois Active, not recruiting
Chicago, Illinois, United States, 60612
Ingalls Memorial Hospital Recruiting
Harvey, Illinois, United States, 60426
Contact: Sulochana D. Yalavarthi    708-915-4673    clinicaltrials@ingalls.org   
Principal Investigator: Sulochana D. Yalavarthi         
United States, Indiana
Saint Vincent Anderson Regional Hospital/Cancer Center Recruiting
Anderson, Indiana, United States, 46016
Contact: Maria J. Valente    904-538-3667      
Principal Investigator: Maria J. Valente         
Franciscan Saint Margaret Health-Dyer Campus Recruiting
Dyer, Indiana, United States, 46311
Contact: Robert D. Prock    708-891-9305      
Principal Investigator: Robert D. Prock         
Radiation Oncology Associates PC Recruiting
Fort Wayne, Indiana, United States, 46804
Contact: Brian K. Chang    260-373-8888    parkviewresearch@parkview.com   
Principal Investigator: Brian K. Chang         
Franciscan Saint Margaret Health-Hammond Campus Recruiting
Hammond, Indiana, United States, 46320
Contact: Robert D. Prock    708-891-9305      
Principal Investigator: Robert D. Prock         
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center Recruiting
Ames, Iowa, United States, 50010
Contact: Joseph J. Merchant    515-239-2621      
Principal Investigator: Joseph J. Merchant         
Mercy Cancer Center-West Lakes Recruiting
Clive, Iowa, United States, 50325
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
Iowa Methodist Medical Center Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
Mercy Medical Center - Des Moines Recruiting
Des Moines, Iowa, United States, 50314
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
United States, Louisiana
Mary Bird Perkins Cancer Center Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Robert W. Veith    504-568-2428    emede1@lsuhsc.edu   
Principal Investigator: Robert W. Veith         
Ochsner Clinic CCOP Withdrawn
New Orleans, Louisiana, United States, 70121
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Mini J. Elnaggar    888-562-4763      
Principal Investigator: Mini J. Elnaggar         
United States, Maryland
Sinai Hospital of Baltimore Active, not recruiting
Baltimore, Maryland, United States, 21215
Greater Baltimore Medical Center Recruiting
Baltimore, Maryland, United States, 21204
Contact: Geoffrey A. Neuner    443-849-3706      
Principal Investigator: Geoffrey A. Neuner         
Peninsula Regional Medical Center Recruiting
Salisbury, Maryland, United States, 21801
Contact: Matthew L. Snyder    866-922-6237      
Principal Investigator: Matthew L. Snyder         
Holy Cross Hospital Recruiting
Silver Spring, Maryland, United States, 20910
Contact: Sheela D. Modin    310-754-7552      
Principal Investigator: Sheela D. Modin         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Akila N. Viswanathan    617-724-5200      
Principal Investigator: Akila N. Viswanathan         
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Lisa A. Kachnic    617-638-8265      
Principal Investigator: Lisa A. Kachnic         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Akila N. Viswanathan    617-724-5200      
Principal Investigator: Akila N. Viswanathan         
Lowell General Hospital Recruiting
Lowell, Massachusetts, United States, 01854
Contact: Akila N. Viswanathan    617-724-5200      
Principal Investigator: Akila N. Viswanathan         
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Recruiting
Milford, Massachusetts, United States, 01757
Contact: Akila N. Viswanathan    617-724-5200      
Principal Investigator: Akila N. Viswanathan         
Dana-Farber/Brigham and Women's Cancer Center at South Shore Recruiting
South Weymouth, Massachusetts, United States, 02190
Contact: Akila N. Viswanathan    617-724-5200      
Principal Investigator: Akila N. Viswanathan         
D'Amour Center for Cancer Care Recruiting
Springfield, Massachusetts, United States, 01107
Contact: Seth A. Kaufman    413-794-9338      
Principal Investigator: Seth A. Kaufman         
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106-0995
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
Saint John Hospital and Medical Center Recruiting
Detroit, Michigan, United States, 48236
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
Wayne State University/Karmanos Cancer Institute Active, not recruiting
Detroit, Michigan, United States, 48201
Mercy Health Saint Mary's Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Spectrum Health at Butterworth Campus Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Saint John Macomb-Oakland Hospital Recruiting
Warren, Michigan, United States, 48093
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
United States, Minnesota
Sanford Clinic North-Bemidgi Recruiting
Bemidji, Minnesota, United States, 56601
Contact: Preston D. Steen    701-234-6161      
Principal Investigator: Preston D. Steen         
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Paul W. Sperduto    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Paul W. Sperduto         
Ridgeview Medical Center Recruiting
Waconia, Minnesota, United States, 55387
Contact: Paul W. Sperduto    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Paul W. Sperduto         
United States, Missouri
Saint John's Mercy Medical Center Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Jay W. Carlson    800-821-7532    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
CoxHealth South Hospital Recruiting
Springfield, Missouri, United States, 65807
Contact: Jay W. Carlson    800-821-7532    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
Mercy Hospital Springfield Recruiting
Springfield, Missouri, United States, 65804
Contact: Jay W. Carlson    800-821-7532    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
United States, Montana
Billings Clinic Recruiting
Billings, Montana, United States, 59107-7000
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
United States, Nebraska
The Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Andrew O. Wahl    800-999-5465      
Principal Investigator: Andrew O. Wahl         
United States, New Jersey
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County Recruiting
Mount Holly, New Jersey, United States, 08060
Contact: Lemuel S. Ariaratnam    888-847-8823      
Principal Investigator: Lemuel S. Ariaratnam         
Capital Health Medical Center-Hopewell Recruiting
Pennington, New Jersey, United States, 08534
Contact: Shirnett K. Williamson    800-255-3440      
Principal Investigator: Shirnett K. Williamson         
Virtua West Jersey Hospital Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Lemuel S. Ariaratnam    888-847-8823      
Principal Investigator: Lemuel S. Ariaratnam         
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Thomas M. Schroeder    505-272-6972      
Principal Investigator: Thomas M. Schroeder         
United States, New York
Long Island Jewish Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Contact: Beatrice F. Bloom    516-734-8900      
Principal Investigator: Beatrice F. Bloom         
North Shore-LIJ Health System/Center for Advanced Medicine Recruiting
New Hyde Park, New York, United States, 11040
Contact: Beatrice F. Bloom    516-734-8900      
Principal Investigator: Beatrice F. Bloom         
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
Contact: Tamara E. Weiss    800-862-2215      
Principal Investigator: Tamara E. Weiss         
United States, North Carolina
South Atlantic Radiation Oncology Recruiting
Supply, North Carolina, United States, 28462
Contact: Michael A. Papagikos    910-251-1839      
Principal Investigator: Michael A. Papagikos         
Coastal Carolina Radiation Oncology Recruiting
Wilmington, North Carolina, United States, 28401
Contact: Michael A. Papagikos    910-251-1839      
Principal Investigator: Michael A. Papagikos         
New Hanover Regional Medical Center Recruiting
Wilmington, North Carolina, United States, 28401
Contact: Michael A. Papagikos    910-251-1839      
Principal Investigator: Michael A. Papagikos         
United States, North Dakota
Sanford Bismarck Medical Center Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Preston D. Steen    701-234-6161      
Principal Investigator: Preston D. Steen         
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center Recruiting
Akron, Ohio, United States, 44304
Contact: Charles A. Kunos    330-375-6101      
Principal Investigator: Charles A. Kunos         
Summa Barberton Hospital Recruiting
Barberton, Ohio, United States, 44203
Contact: Charles A. Kunos    330-375-6101      
Principal Investigator: Charles A. Kunos         
Geaugra Hospital Recruiting
Chardon, Ohio, United States, 44024
Contact: Rodney J. Ellis    800-641-2422      
Principal Investigator: Rodney J. Ellis         
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Tracy Sherertz    800-641-2422      
Principal Investigator: Tracy Sherertz         
The Mark H Zangmeister Center Recruiting
Columbus, Ohio, United States, 43219
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Summa Health Center at Lake Medina Recruiting
Medina, Ohio, United States, 44256
Contact: Charles A. Kunos    330-375-6101      
Principal Investigator: Charles A. Kunos         
Lake University Ireland Cancer Center Recruiting
Mentor, Ohio, United States, 44060
Contact: Rodney J. Ellis    800-641-2422      
Principal Investigator: Rodney J. Ellis         
Southwest General Health Center Ireland Cancer Center Recruiting
Middleburg Heights, Ohio, United States, 44130
Contact: Rodney J. Ellis    800-641-2422      
Principal Investigator: Rodney J. Ellis         
UHHS-Chagrin Highlands Medical Center Recruiting
Orange Village, Ohio, United States, 44122
Contact: Rodney J. Ellis    800-641-2422      
Principal Investigator: Rodney J. Ellis         
Southern Ohio Medical Center Recruiting
Portsmouth, Ohio, United States, 45662
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
UHHS-Westlake Medical Center Recruiting
Westlake, Ohio, United States, 44145
Contact: Rodney J. Ellis    800-641-2422      
Principal Investigator: Rodney J. Ellis         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Terence S. Herman    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Terence S. Herman         
United States, Pennsylvania
Abington Memorial Hospital Active, not recruiting
Abington, Pennsylvania, United States, 19001
Paoli Memorial Hospital Recruiting
Paoli, Pennsylvania, United States, 19301
Contact: Albert S. DeNittis    866-225-5654      
Principal Investigator: Albert S. DeNittis         
Radiation Therapy Oncology Group Recruiting
Philadelphia, Pennsylvania, United States, 19103
Contact: Ann H. Klopp       aklopp@mdanderson.org   
Principal Investigator: Ann H. Klopp         
Mount Nittany Medical Center Recruiting
State College, Pennsylvania, United States, 16803
Contact: Jerome D. Derdel    814-231-7813    smoyer@mountnittany.org   
Principal Investigator: Jerome D. Derdel         
Reading Hospital Recruiting
West Reading, Pennsylvania, United States, 19611
Contact: Albert Yuen    610-988-9323      
Principal Investigator: Albert Yuen         
Lankenau Hospital Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Albert S. DeNittis    866-225-5654      
Principal Investigator: Albert S. DeNittis         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Samuel L. Cooper    843-792-9321      
Principal Investigator: Samuel L. Cooper         
Self Regional Healthcare Recruiting
Greenwood, South Carolina, United States, 29646
Contact: Samuel L. Cooper    843-792-9321      
Principal Investigator: Samuel L. Cooper         
United States, South Dakota
Rapid City Regional Hospital Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Michael J. Swartz    605-716-3982    research@rcrh.org   
Principal Investigator: Michael J. Swartz         
Sanford USD Medical Center - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contact: Miroslaw A. Mazurczak    605-328-1367      
Principal Investigator: Miroslaw A. Mazurczak         
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Kevin V. Albuquerque    214-648-7097      
Principal Investigator: Kevin V. Albuquerque         
M D Anderson Cancer Center Active, not recruiting
Houston, Texas, United States, 77030
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Ann H. Klopp    713-792-3245      
Principal Investigator: Ann H. Klopp         
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Tony Y. Eng    210-567-0653    che@uthscsa.edu   
Principal Investigator: Tony Y. Eng         
United States, Utah
Logan Regional Hospital Recruiting
Logan, Utah, United States, 84321
Contact: R. J. Lee    801-507-3950      
Principal Investigator: R. J. Lee         
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: R. J. Lee    801-507-3950      
Principal Investigator: R. J. Lee         
Dixie Medical Center Regional Cancer Center Recruiting
Saint George, Utah, United States, 84770
Contact: R. J. Lee    801-507-3950      
Principal Investigator: R. J. Lee         
Huntsman Cancer Institute/University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: David K. Gaffney    801-581-4477    clinical.trials@hci.utah.edu   
Principal Investigator: David K. Gaffney         
LDS Hospital Recruiting
Salt Lake City, Utah, United States, 84143
Contact: R. J. Lee    801-507-3950      
Principal Investigator: R. J. Lee         
United States, Washington
Saint Francis Hospital Recruiting
Federal Way, Washington, United States, 98003
Contact: Huong T. Pham    800-354-9527      
Principal Investigator: Huong T. Pham         
Virginia Mason CCOP Recruiting
Seattle, Washington, United States, 98101
Contact: Huong T. Pham    800-354-9527      
Principal Investigator: Huong T. Pham         
United States, West Virginia
Edwards Comprehensive Cancer Center Recruiting
Huntington, West Virginia, United States, 25701
Contact: Maria R. Tria Tirona    304-399-6617      
Principal Investigator: Maria R. Tria Tirona         
United States, Wisconsin
Aurora BayCare Medical Center Recruiting
Green Bay, Wisconsin, United States, 54311-6519
Contact: David C. Rohde    800-252-2990      
Principal Investigator: David C. Rohde         
Aurora Saint Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: David C. Rohde    800-252-2990      
Principal Investigator: David C. Rohde         
Aurora West Allis Medical Center Recruiting
West Allis, Wisconsin, United States, 53227
Contact: David C. Rohde    800-252-2990      
Principal Investigator: David C. Rohde         
Canada, British Columbia
BCCA-Cancer Centre for the Southern Interior Active, not recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
BCCA-Vancouver Island Cancer Centre Recruiting
Victoria, British Columbia, Canada, V8R 6V5
Contact: Caroline L. Holloway    604-877-6010      
Principal Investigator: Caroline L. Holloway         
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Iwa Kong    905-387-9495      
Principal Investigator: Iwa Kong         
London Regional Cancer Program Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Brian P. Yaremko    519-685-8600      
Principal Investigator: Brian P. Yaremko         
Canada, Saskatchewan
Allan Blair Cancer Centre Recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Contact: Evgeny Sadikov    306-766-2213      
Principal Investigator: Evgeny Sadikov         
Saskatoon Cancer Centre Recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Contact: Vijayananda Kundapur    306-655-2914      
Principal Investigator: Vijayananda Kundapur         
Hong Kong
Pamela Youde Nethersole Eastern Hospital Recruiting
Chai Wan, Hong Kong
Contact: Amy T. Chang    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Amy T. Chang         
Singapore
National University Hospital Terminated
Singapore, Singapore, 119074
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Principal Investigator: Ann Klopp, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01672892     History of Changes
Other Study ID Numbers: RTOG 1203, CDR0000738944, NCI-2012-02001
Study First Received: August 23, 2012
Last Updated: October 27, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
gastrointestinal complications
perioperative/postoperative complications
radiation toxicity
urinary complications
urinary tract toxicity
endometrial clear cell carcinoma
endometrial papillary serous carcinoma
stage IA endometrial carcinoma
stage IB endometrial carcinoma
stage II endometrial carcinoma
stage IIIA endometrial carcinoma
stage IIIB endometrial carcinoma
stage IIIC endometrial carcinoma
endometrial adenocarcinoma
cervical adenocarcinoma
stage IB cervical cancer
stage IIA cervical cancer
stage IIB cervical cancer

Additional relevant MeSH terms:
Postoperative Complications
Radiation Injuries
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Pathologic Processes
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014