Esophageal Cancer Clinical Trial
Official title:
A PHASE III INTERGROUP RANDOMIZED COMPARISON OF COMBINED MODALITY THERAPY FOR CARCINOMA OF THE ESOPHAGUS: HIGH-DOSE VS CONVENTIONAL-DOSE RADIATION THERAPY
Verified date | November 2013 |
Source | Radiation Therapy Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 298 |
Est. completion date | |
Est. primary completion date | September 1999 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Saskatchewan Cancer Agency | Regina | Saskatchewan |
United States | Quain & Ramstad Clinic, P.C. | Bismarck | North Dakota |
United States | CCOP - Cedar Rapids Oncology Project | Cedar Rapids | Iowa |
United States | CCOP - Geisinger Clinical and Medical Center | Danville | Pennsylvania |
United States | CCOP - Iowa Oncology Research Association | Des Moines | Iowa |
United States | CCOP - Duluth | Duluth | Minnesota |
United States | CCOP - Merit Care Hospital | Fargo | North Dakota |
United States | Altru Health Systems | Grand Forks | North Dakota |
United States | CCOP - Illinois Oncology Research Association | Peoria | Illinois |
United States | Rapid City Regional Hospital | Rapid City | South Dakota |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | CentraCare Clinic | Saint Cloud | Minnesota |
United States | CCOP - Scottsdale Oncology Program | Scottsdale | Arizona |
United States | Siouxland Hematology-Oncology | Sioux City | Iowa |
United States | CCOP - Sioux Community Cancer Consortium | Sioux Falls | South Dakota |
United States | CCOP - Toledo Community Hospital Oncology Program | Toledo | Ohio |
United States | CCOP - Carle Cancer Center | Urbana | Illinois |
United States | CCOP - Wichita | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
Radiation Therapy Oncology Group | Eastern Cooperative Oncology Group, National Cancer Institute (NCI), North Central Cancer Treatment Group |
United States, Canada,
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-1
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 f — View Citation
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 Clinica
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 — View Citation
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. — View Citation
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. — View Citation
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