Phase III Comparison of Radiotherapy Alone vs Radiotherapy plus Combination Chemotherapy with CACP/5-FU in Patients with Localized Carcinoma of the Esophagus
Basic Trial Information
|Phase III||Treatment||Closed||18 and over||NCI||RTOG-8501|
NCCTG-884051, SWOG-8598, RTOG-85-01
I. Compare in a randomized Phase III trial radiotherapy plus combination chemotherapy with 5-fluorouracil/cis-platinum vs. radiotherapy alone with regard to cure rate and overall survival among patients with localized carcinoma of the esophagus. II. Determine whether patterns of recurrence are different in the two treatment groups.
Biopsy-proven squamous cell carcinoma or adenocarcinoma of the thoracic esophagus Disease limited to the esophagus as verified by physical examination, triple endoscopy, biopsy, staging studies Negative liver biopsy required if pretreatment liver CT abnormal Laparotomy with negative biopsy required if abdominal CT shows enlarged retroperitoneal or celiac nodes Bone biopsy required to rule out tumor in area(s) of positive bone scan unless explained from benign disease Normal endoscopy of tracheal bronchial tree and structures of the upper aerodigestive tract required
Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior chest irradiation Surgery: No prior resection of tumor
Age: Any age Hematopoietic: WBC at least 4,000 Platelets at least 100,000 Hepatic: Not specified Renal: BUN not greater than 22 mg/dl Creatinine not greater than 1.5 mg/dl OR Creatinine clearance at least 60 ml/min Other: No second malignancy except: Curable nonmelanomatous skin cancer Carcinoma in situ of uterine cervix
Up to 150 patients will be entered over about 3.5 years. Arm II was closed on 05/14/90 because of statistically superior survival on Arm I.
Randomized study. Because interim analysis revealed statistically superior survival for patients treated on Arm I, Arm II was closed to further patient entry as of 05/14/90. Eligible patients continue to be entered on Arm I. Arm I: Radiotherapy plus 2-Drug Combination Chemotherapy. Irradiation of the tumor field using megavoltage equipment; plus 5-Fluorouracil, 5-FU, NSC-19893; cis-Platinum, CACP, NSC-119875. Arm II (Arm closed 05/14/90): Radiotherapy as in Arm I.
Cooper JS, Guo MD, Herskovic A, et al.: Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG 85-01). Radiation Therapy Oncology Group. JAMA 281 (17): 1623-7, 1999.[PUBMED Abstract]
Streeter OE Jr, Martz KL, Gaspar LE, et al.: Does race influence survival for esophageal cancer patients treated on the radiation and chemotherapy arm of RTOG #85-01? Int J Radiat Oncol Biol Phys 44 (5): 1047-52, 1999.[PUBMED Abstract]
al-Sarraf M, Martz K, Herskovic A, et al.: Progress report of combined chemoradiotherapy versus radiotherapy alone in patients with esophageal cancer: an intergroup study. J Clin Oncol 15 (1): 277-84, 1997.[PUBMED Abstract]
Al-Sarraf M, Martz K, Herskovic A, et al.: Superiority of chemo-radiotherapy (CT-RT) vs. Radiotherapy (RT) in patients with esophageal cancer. Final report of an intergroup randomized and confirmed study. [Abstract] Proceedings of the American Society of Clinical Oncology 15: A464, 206, 1996.
Streeter OE Jr, Martz KL, Gaspar LE, et al.: Does race influence survival for esophageal cancers treated on the radiation and chemotherapy arm of RTOG 85-01? [Abstract] Int J Radiat Oncol Biol Phys 32 (suppl 1): A-2012, 268, 1995.
Al-Sarraf M, Pajak T, Herskovic A, et al.: Progress report of combined chemo-radiotherapy (CT-RT) vs radiotherapy (RT) alone in patients with esophageal cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-580, 197, 1993.
Herskovic A, Martz K, al-Sarraf M, et al.: Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus. N Engl J Med 326 (24): 1593-8, 1992.[PUBMED Abstract]
Thomas CR Jr, Berkey BA, Minsky BD, et al.: 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 58 (5): 1405-10, 2004.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations
Radiation Therapy Oncology Group
Southwest Oncology Group
North Central Cancer Treatment Group
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.