- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002631
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Cancer of the Esophagus
A PHASE III INTERGROUP RANDOMIZED COMPARISON OF COMBINED MODALITY THERAPY FOR CARCINOMA OF THE ESOPHAGUS: HIGH-DOSE VS CONVENTIONAL-DOSE RADIATION THERAPY
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not known whether high-dose radiation therapy is more effective than standard dose radiation therapy in treating cancer of the esophagus.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy plus high- or standard-dose radiation therapy in treating patients with cancer of the esophagus.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES: I. Compare, using a prospective controlled randomized study design, the survival and failure patterns associated with conventional-dose radiotherapy and fluorouracil/cisplatin (5-FU/CDDP) vs. high-dose radiotherapy and 5-FU/CDDP in patients with esophageal cancer. II. Compare the tolerance and quality of life of patients receiving these therapies.
OUTLINE: Randomized study. Arm I: Radiotherapy plus 2-Drug Combination Chemotherapy/Radiosensitization. Tumor irradiation using megavoltage photons of at least 6 MV (electrons may be used if required to boost supraclavicular fossa dose); plus Cisplatin, CDDP, NSC-119875; Fluorouracil, 5-FU, NSC-19893. High-dose radiotherapy. Arm II: Radiotherapy plus 2-Drug Combination Chemotherapy/Radiosensitization. Tumor irradiation as in Arm I; plus CDDP/5-FU. Conventional-dose radiotherapy.
PROJECTED ACCRUAL: Up to 298 patients will be entered over 4 years.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Saskatchewan
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Regina, Saskatchewan, Canada, S4S 6X3
- Saskatchewan Cancer Agency
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Arizona
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Scottsdale, Arizona, United States, 85259-5404
- CCOP - Scottsdale Oncology Program
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Illinois
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Peoria, Illinois, United States, 61602
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids, Iowa, United States, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, United States, 10309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City, Iowa, United States, 51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
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Minnesota
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Duluth, Minnesota, United States, 55805
- CCOP - Duluth
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, United States, 56303
- CentraCare Clinic
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North Dakota
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Bismarck, North Dakota, United States, 58501
- Quain & Ramstad Clinic, P.C.
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Fargo, North Dakota, United States, 58122
- CCOP - Merit Care Hospital
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Grand Forks, North Dakota, United States, 58201
- Altru Health Systems
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Ohio
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Toledo, Ohio, United States, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Pennsylvania
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Danville, Pennsylvania, United States, 17822-2001
- CCOP - Geisinger Clinical and Medical Center
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South Dakota
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Rapid City, South Dakota, United States, 57709
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, United States, 57105-1080
- CCOP - Sioux Community Cancer Consortium
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Biopsy-proven primary squamous cell or adenocarcinoma of the esophagus Clinical Stage T1-4, Nx, M0 disease required Disease entirely confined to the esophagus and periesophageal soft tissue with no tumor extension within 2 cm proximal to the stomach No biopsy-proven invasion of the tracheal-bronchial tree or tracheal-esophageal (TE) fistula Bronchoscopy of tracheal-bronchial tree required for lesions less than 30 cm from the incisors to exclude TE fistula Negative liver biopsy required if liver CT suggestive of metastatic disease Negative biopsy required for enlarged (1.5 cm or greater) retroperitoneal or celiac nodes seen on CT Negative biopsy of clinically or radiographically positive supraclavicular nodes required with cervical primaries No recurrent disease No multiple carcinomas of the esophagus
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100% Hematopoietic: WBC at least 4,000 Platelets at least 150,000 Hb at least 10 g/dL Hepatic: Not specified Renal: Creatinine normal OR Creatinine clearance at least 65 mL/min Nutrition: Recommended oral intake requirements (by mouth or tube feeding): More than 1.5 x Basal Energy Expenditure (BEE) measured by Harris- Benedict equation OR More than 1,000 calories/sqm of body surface area (BSA) Intravenous hyperalimentation (recommended if inadequate oral intake): 1.75-2.25 x BEE OR 1,200-1,600 calories/sqm BSA Upper limits may be waived for hypermetabolic patients Other: No second malignancy within 5 years except: Curable nonmelanomatous skin cancer Cervical cancer in situ No pregnant or nursing women
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior or concurrent growth factor administration Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior chest irradiation Surgery: No prior resection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Thomas M. Pisansky, MD, Mayo Clinic
- Study Chair: James A. Martenson, MD, Mayo Clinic
- Study Chair: Bruce D. Minsky, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
General Publications
- Thomas CR Jr, Berkey BA, Minsky BD, Gaspar LE, Herskovic A, Rich TA, Gunderson LL. Recursive partitioning analysis of pretreatment variables of 416 patients with locoregional esophageal cancer treated with definitive concomitant chemoradiotherapy on Intergroup and Radiation Therapy Oncology Group trials. Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1405-10. doi: 10.1016/j.ijrobp.2003.09.022.
- Smalley SR, Gunderson L, Tepper J, Martenson JA Jr, Minsky B, Willett C, Rich T. Gastric surgical adjuvant radiotherapy consensus report: rationale and treatment implementation. Int J Radiat Oncol Biol Phys. 2002 Feb 1;52(2):283-93. doi: 10.1016/s0360-3016(01)02646-3.
- Kachnic LA, Winter K, Wasserman T, Kelsen D, Ginsberg R, Pisansky TM, Martenson J, Komaki R, Okawara G, Rosenthal SA, Willett CG, Minsky BD. Longitudinal Quality-of-Life Analysis of RTOG 94-05 (Int 0123):A Phase III Trial of Definitive Chemoradiotherapy for Esophageal Cancer. Gastrointest Cancer Res. 2011 Mar;4(2):45-52.
- Minsky BD, Pajak TF, Ginsberg RJ, Pisansky TM, Martenson J, Komaki R, Okawara G, Rosenthal SA, Kelsen DP. INT 0123 (Radiation Therapy Oncology Group 94-05) phase III trial of combined-modality therapy for esophageal cancer: high-dose versus standard-dose radiation therapy. J Clin Oncol. 2002 Mar 1;20(5):1167-74. doi: 10.1200/JCO.2002.20.5.1167.
- Kachnic LA, Scott C, Ginsberg R, et al.: One year follow-up reveals no difference in quality of life between high dose and conventional dose radiation: a quality of life assessment of RTOG 94-05. [Abstract] Int J Radiat Oncol Biol Phys 51 (3 suppl 1): A-172, 97, 2001.
- Minsky BD, Berkey B, Kelsen DK, et al.: Preliminary results of Intergroup INT 0123 randomized trial of combined modality therapy (CMT) for esophagel cancer: standard vs high dose radiation therapy. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A927, 2000.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Cisplatin
- Fluorouracil
Other Study ID Numbers
- RTOG-9405
- CDR0000064043
- E-R9405
- NCCTG-914051
- INT-0123
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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