PET Scan Imaging in Assessing Response in Patients With Esophageal Cancer Receiving Combination Chemotherapy
This study is currently recruiting participants.
Verified February 2013 by National Cancer Institute (NCI)
Sponsor:
Cancer and Leukemia Group B
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01333033
First received: April 7, 2011
Last updated: February 15, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: PET scans done during chemotherapy may help doctors assess a patient's response to treatment and help plan the best treatment.
PURPOSE: This randomized phase II trial is studying PET scan imaging in assessing response in patients with esophageal cancer receiving combination chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Adenocarcinoma of the Gastroesophageal Junction Esophageal Cancer |
Drug: FOLFOX regimen Drug: carboplatin Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Drug: paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer |
Resource links provided by NLM:
Drug Information available for:
Fluorouracil
Calcium Gluconate
Leucovorin calcium
Paclitaxel
Carboplatin
Oxaliplatin
Levoleucovorin
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- pCR rate of PET/CT non-responders within each induction treatment group [ Designated as safety issue: No ]
Secondary Outcome Measures:
- PET/CT response between treatment arms [ Designated as safety issue: No ]
- pCR rate among induction treatment PET/CT scan responders [ Designated as safety issue: No ]
- PFS and OS at 8 months [ Designated as safety issue: No ]
| Estimated Enrollment: | 204 |
| Study Start Date: | September 2011 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreased by ≥ 35%) receive 3 additional courses of FOLFOX-6 therapy and undergo concurrent radiotherapy (RT) (3D-conformal or intensity-modulated) once daily, 5 days a week, for approximately 6 weeks. Patients without responsive disease (tumor metabolic activity did not decrease by 35%) cross over to arm II during RT.
|
Drug: FOLFOX regimen
Given IV
Drug: fluorouracil
Given IV
Drug: leucovorin calcium
Given IV
Drug: oxaliplatin
Given IV
|
|
Experimental: Arm II
Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases ≥ 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks. Patients without responsive disease (metabolic activity did not decrease by 35%) cross over to arm I during RT.
|
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Surgically resectable, histologically confirmed esophageal adenocarcinoma, including Siewert gastroesophageal (GE) junction adenocarcinomas Types 1 and 2
T1 N1-3 M0 or T2-4 N any M0 as determined by endoscopic ultrasound (EUS) and PET/CT (histologic confirmation of lymph involvement is not required)
- All patients must have locoregional staging determined by EUS if technically feasible
- All disease (tumor and nodes) must be both surgically resectable and capable of containment in a radiotherapy field
- Endoscopy reports should clearly state both the T and N stage
- No T4 tumor with clear evidence of invasion of the vertebral column, heart, great vessels, or tracheobronchial tree
- No evidence of distant metastases (as determined by EUS or PET/CT)
- Patients with cervical, supraclavicular, or other nodal disease that is either not included in the radiation field or is not able to be resected at the time of esophagectomy are not eligible
- Patient must have pre-resection tissue available for central pathology review
- Patients must have detectable fluorine-18-labeled deoxyglucose (FDG) uptake on baseline PET/CT scan of primary tumor
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- ANC ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Hemoglobin ≥ 9 g/dL
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Creatinine clearance ≥ 60 mL/min
- AST/ALT ≤ 2.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
No prior malignancy within 5 years, with the exception of basal or squamous cell skin cancers, or in situ bladder or cervical cancer
- Patients with prior malignancy treated with surgery only and disease-free for more than 5 years are eligible
- No history of severe hypersensitivity reaction to Cremaphor® EL
- No known contraindication to the use of fluorouracil, taxanes, or platinum compounds
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior thoracic radiotherapy (RT), abdominal RT, or chemotherapy
- No concurrent epoetin
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333033
Hide Study Locations
Hide Study LocationsLocations
| United States, California | |
| Camino Medical Group - Treatment Center | Recruiting |
| Mountain View, California, United States, 94040 | |
| Contact: Peter P. Yu, MD 408-524-5814 | |
| Palo Alto Medical Foundation | Recruiting |
| Palo Alto, California, United States, 94301 | |
| Contact: Peter P. Yu, MD 408-524-5814 | |
| UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |
| United States, Connecticut | |
| Yale Cancer Center | Recruiting |
| New Haven, Connecticut, United States, 06520-8028 | |
| Contact: Clinical Trials Office - Yale Cancer Center 203-785-5702 | |
| United States, Delaware | |
| Tunnell Cancer Center at Beebe Medical Center | Recruiting |
| Lewes, Delaware, United States, 19958 | |
| Contact: Clinical Trials Office - Tunnell Cancer Center 302-645-3171 | |
| CCOP - Christiana Care Health Services | Recruiting |
| Newark, Delaware, United States, 19713 | |
| Contact: Clinical Trial Office - CCOP - Christiana Care Health Services 302-623-4450 | |
| United States, District of Columbia | |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center 202-444-0381 | |
| United States, Hawaii | |
| Oncare Hawaii, Incorporated - Pali Momi | Recruiting |
| Aiea, Hawaii, United States, 96701 | |
| Contact: Jeffrey L. Berenberg, MD 808-433-4089 | |
| Kapiolani Medical Center at Pali Momi | Recruiting |
| Aiea, Hawaii, United States, 96701 | |
| Contact: Jeffrey L. Berenberg, MD 808-433-4089 | |
| Kapiolani Medical Center for Women and Children | Recruiting |
| Honolulu, Hawaii, United States, 96826 | |
| Contact: Jeffrey L. Berenberg, MD 808-433-4089 | |
| Kuakini Medical Center | Recruiting |
| Honolulu, Hawaii, United States, 96817 | |
| Contact: Jeffrey L. Berenberg, MD 808-433-4089 | |
| OnCare Hawaii, Incorporated - Kuakini | Recruiting |
| Honolulu, Hawaii, United States, 96817-3169 | |
| Contact: Jeffrey L. Berenberg, MD 808-433-4089 | |
| OnCare Hawaii, Incorporated - Lusitana | Recruiting |
| Honolulu, Hawaii, United States, 96813 | |
| Contact: Jeffrey L. Berenberg, MD 808-433-4089 | |
| Queen's Cancer Institute at Queen's Medical Center | Recruiting |
| Honolulu, Hawaii, United States, 96813 | |
| Contact: Jeffrey L. Berenberg, MD 808-433-4089 | |
| Straub Clinic and Hospital, Incorporated | Recruiting |
| Honolulu, Hawaii, United States, 96813 | |
| Contact: Jeffrey L. Berenberg, MD 808-433-4089 | |
| Castle Medical Center | Recruiting |
| Kailua, Hawaii, United States, 96734 | |
| Contact: Jeffrey L. Berenberg, MD 808-433-4089 | |
| Kauai Medical Clinic | Recruiting |
| Lihue, Hawaii, United States, 96766 | |
| Contact: Jeffrey L. Berenberg, MD 808-433-4089 | |
| United States, Illinois | |
| John H. Stroger, Jr. Hospital of Cook County | Recruiting |
| Chicago, Illinois, United States, 60612-3785 | |
| Contact: Thomas E. Lad, MD 312-864-3200 | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611-3013 | |
| Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 cancer@northwestern.edu | |
| University of Chicago Cancer Research Center | Recruiting |
| Chicago, Illinois, United States, 60637-1470 | |
| Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | Recruiting |
| Peoria, Illinois, United States, 61615 | |
| Contact: Nguyet A. Le-Lindqwister 309-243-3000 | |
| CCOP - Illinois Oncology Research Association | Recruiting |
| Peoria, Illinois, United States, 61615 | |
| Contact: Nguyet A. Le-Lindqwister 309-243-3605 | |
| CCOP - Carle Cancer Center | Recruiting |
| Urbana, Illinois, United States, 61801 | |
| Contact: Clinical Trials Office - CCOP - Carle Cancer Center 800-446-5532 | |
| United States, Iowa | |
| McFarland Clinic, PC | Recruiting |
| Ames, Iowa, United States, 50010 | |
| Contact: Clinical Trials Office - McFarland Clinic, PC 515-239-2621 | |
| Siouxland Hematology-Oncology Associates, LLP | Recruiting |
| Sioux City, Iowa, United States, 51101 | |
| Contact: Donald B. Wender, MD, PhD 712-252-0088 | |
| United States, Maryland | |
| Union Hospital of Cecil County | Recruiting |
| Elkton MD, Maryland, United States, 21921 | |
| Contact: Stephen S. Grubbs, MD 302-366-1200 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130 | |
| United States, Michigan | |
| Saint Joseph Mercy Cancer Center | Recruiting |
| Ann Arbor, Michigan, United States, 48106-0995 | |
| Contact: Philip J. Stella, MD 734-712-1000 | |
| United States, Minnesota | |
| United Hospital | Recruiting |
| Saint Paul, Minnesota, United States, 55102 | |
| Contact: Patrick J. Flynn, MD 612-884-6300 | |
| Regions Hospital Cancer Care Center | Recruiting |
| St. Paul, Minnesota, United States, 55101 | |
| Contact: Clinical Trials Office - Regions Hospital Cancer Care Center 651-254-1517 | |
| United States, Mississippi | |
| University of Mississippi Cancer Clinic | Recruiting |
| Jackson, Mississippi, United States, 39216 | |
| Contact: Robert D. Hamilton 601-984-5590 | |
| Regional Cancer Center at Singing River Hospital | Recruiting |
| Pascagoula, Mississippi, United States, 39581 | |
| Contact: James E. Clarkson, MD 228-374-6296 | |
| United States, Missouri | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Albert C. Lockhart, MD 615-322-4967 | |
| United States, Montana | |
| Billings Clinic - Downtown | Recruiting |
| Billings, Montana, United States, 59107-7000 | |
| Contact: Clinical Trials Office - Billings Clinic - Downtown 800-996-2663 research@billingsclinic.org | |
| United States, Nebraska | |
| Methodist Estabrook Cancer Center | Recruiting |
| Omaha, Nebraska, United States, 68114 | |
| Contact: Yungpo B. Su 402-354-5890 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675 | |
| Cancer Institute of New Jersey at Cooper - Voorhees | Recruiting |
| Voorhees, New Jersey, United States, 08043 | |
| Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo 856-325-6757 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: David H. Ilson 212-639-8895 | |
| Mount Sinai Medical Center | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Celina S. Ang 212-241-6500 | |
| NYU Cancer Institute at New York University Medical Center | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Deirdre J. Cohen 212-263-6485 | |
| SUNY Upstate Medical University Hospital | Recruiting |
| Syracuse, New York, United States, 13210 | |
| Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi 315-464-5476 | |
| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683; 919-966-4432 | |
| Blumenthal Cancer Center at Carolinas Medical Center | Recruiting |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas 704-355-2884 | |
| Presbyterian Cancer Center at Presbyterian Hospital | Recruiting |
| Charlotte, North Carolina, United States, 28233-3549 | |
| Contact: Clinical Trials Office - Presbyterian Cancer Center at Presbyt 704-384-5369 | |
| Iredell Memorial Hospital | Recruiting |
| Statesville, North Carolina, United States, 28677 | |
| Contact: Ruby A. Grimm, MD 704-873-2219 | |
| United States, North Dakota | |
| CCOP - MeritCare Hospital | Recruiting |
| Fargo, North Dakota, United States, 58122 | |
| Contact: Preston D. Steen, MD 701-234-2397 | |
| MeritCare Broadway | Recruiting |
| Fargo, North Dakota, United States, 58102 | |
| Contact: Preston D. Steen, MD 701-234-2397 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Recruiting |
| Columbus, Ohio, United States, 43210-1240 | |
| Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 Jamesline@osumc.edu | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Carla Kurkjian 405-271-6822 | |
| United States, Pennsylvania | |
| Forbes Regional Hospital | Recruiting |
| Monroeville, Pennsylvania, United States, 15146 | |
| Contact: Lana Y. Schumacher 412-858-2000 | |
| Alle-Kiski Medical Center | Recruiting |
| Natrona Heights, Pennsylvania, United States, 15065 | |
| Contact: Lana Y. Schumacher 724-224-5100 | |
| Fox Chase Cancer Center CCOP Research Base | Recruiting |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Contact: Clinical Trials Office - Fox Chase Cancer Center CCOP Research 215-728-2983 | |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107-5541 | |
| Contact: Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer 215-955-6084 | |
| Allegheny Cancer Center at Allegheny General Hospital | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Contact: Robert J. Keenan, MD 412-359-6202 | |
| UPMC Cancer Centers | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073 | |
| United States, South Carolina | |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Recruiting |
| Spartanburg, South Carolina, United States, 29303 | |
| Contact: Clinical Trials Office - Gibbs Regional Cancer Center 800-486-5941 | |
| United States, Vermont | |
| Mountainview Medical | Recruiting |
| Berlin, Vermont, United States, 05602 | |
| Contact: Steven Ades 802-223-6196 | |
| Fletcher Allen Health Care - University Health Center Campus | Recruiting |
| Burlington, Vermont, United States, 05401 | |
| Contact: Clinical Trials Office - Fletcher Allen Health Care 802-656-8990 | |
| United States, Wisconsin | |
| Center for Cancer Treatment & Prevention at Sacred Heart Hospital | Recruiting |
| Eau Claire, Wisconsin, United States, 54701 | |
| Contact: Elena N. Theodosiou 715-839-3956 | |
| Saint Joseph's Hospital | Recruiting |
| Marshfield, Wisconsin, United States, 54449 | |
| Contact: Elena N. Theodosiou 715-387-1713 | |
| Marshfield Clinic - Marshfield Center | Recruiting |
| Marshfield, Wisconsin, United States, 54449 | |
| Contact: Clinical Trials Office - Marshfield Clinic - Marshfield Center 800-782-1581 ext. 94457 | |
| Marshfield Clinic - Lakeland Center | Recruiting |
| Minocqua, Wisconsin, United States, 54548 | |
| Contact: Elena N. Theodosiou 715-358-1000 | |
| Ministry Medical Group at Saint Mary's Hospital | Recruiting |
| Rhinelander, Wisconsin, United States, 54501 | |
| Contact: Elena N. Theodosiou 715-361-4700 | |
| Marshfield Clinic - Indianhead Center | Recruiting |
| Rice Lake, Wisconsin, United States, 54868 | |
| Contact: Elena N. Theodosiou 715-236-8100 | |
| Saint Michael's Hospital Cancer Center | Recruiting |
| Stevens Point, Wisconsin, United States, 54481 | |
| Contact: Elena N. Theodosiou 715-346-5000 | |
| Marshfield Clinic at Saint Michael's Hospital | Recruiting |
| Stevens Point, Wisconsin, United States, 54481 | |
| Contact: Elena N. Theodosiou 715-295-1900 | |
| Marshfield Clinic - Weston Center | Recruiting |
| Weston, Wisconsin, United States, 54476 | |
| Contact: Elena N. Theodosiou 715-393-1000 | |
| Diagnostic and Treatment Center | Recruiting |
| Weston, Wisconsin, United States, 54476 | |
| Contact: Elena N. Theodosiou 715-393-3900 | |
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
| Principal Investigator: | Karyn A. Goodman, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Monica M. Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT01333033 History of Changes |
| Other Study ID Numbers: | CDR0000698428, CALGB-80803 |
| Study First Received: | April 7, 2011 |
| Last Updated: | February 15, 2013 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the gastroesophageal junction adenocarcinoma of the esophagus stage IB esophageal cancer stage IIA esophageal cancer |
stage IIB esophageal cancer stage IIIA esophageal cancer stage IIIB esophageal cancer stage IIIC esophageal cancer |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Esophageal Diseases Esophageal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms |
Fluorouracil Oxaliplatin Carboplatin Paclitaxel Leucovorin Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013