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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
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed18 and overNCIRTOG-8501
NCCTG-884051, SWOG-8598, RTOG-85-01

Objectives

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.

Entry Criteria

Disease Characteristics:


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


Prior/Concurrent Therapy:


Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior chest irradiation

Surgery:
  No prior resection of tumor


Patient Characteristics:


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


Expected Enrollment

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.

Outline

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.

Published Results

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]

Related Publications

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

Arnold Herskovic, MD, Protocol chair
Ph: 847-618-6576
Email: arnoldh134@aol.com

Southwest Oncology Group

Claudia Perez-Tamayo, MD, Protocol chair
Ph: 785-452-4820

North Central Cancer Treatment Group

James Martenson, MD, Protocol chair
Ph: 507-284-4561

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.

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