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Phase III Randomized Comparison of Radiotherapy vs Radiotherapy plus 5-FU/MITO for Stage I/II Carcinoma of the Esophagus (Summary last modified 06/97)

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompleted18 to 71NCIEST-1282

Objectives

I.  Determine whether the combined administration of 
5-fluorouracil/mitomycin-C concurrently with radiotherapy improves the 
symptom-free period and survival compared with radiotherapy alone in patients 
with inoperable Stage I-II carcinoma of the esophagus.
II.  Assess tumor regression at the time of operation in patients treated with 
combined radiotherapy plus chemotherapy vs. those treated with irradiation 
alone among those patients selected for surgery after 4,000 rads.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Previously untreated patients under 
the age of 72 years with histologically proven squamous cell carcinoma of the 
esophagus, Stage I or II.  Hepatic, renal, and hematopoietic function must be 
adequate and the ECOG performance status must be 0-2.  Patients must be 
ingesting either more than 150 percent of the Basal Energy Expenditure as 
measured by the Harris-Benedict equation or more than 1,000 calories/sqm; 
otherwise, iv hyperalimentation is required for eligibility.  Patients must be 
free of all infection and may not have multiple tumors of the esophagus or 
other primary carcinomas within 5 years of entry, excepting skin cancer.  
There may have been no prior chemotherapy, radiotherapy, or surgery, and there 
may be no distant metastases or distant positive nodes (cervical, 
supraclavicular, celiac).

Expected Enrollment

65 patients will be entered on each arm over about 2.5 years.

Outline

Randomized study.
Arm I:  Radiotherapy.  Tumor irradiation using supervoltage therapy or 
teletherapy.
Arm II:  Radiotherapy plus 2-Drug Combination Chemotherapy.  Tumor 
irradiation; plus 5-Fluorouracil, 5-FU, NSC-19893; Mitomycin-C, MITO, 
NSC-26980.

Published Results

Smith TJ, Ryan LM, Douglass HO Jr, et al.: Combined chemoradiotherapy vs. radiotherapy alone for early stage squamous cell carcinoma of the esophagus: a study of the Eastern Cooperative Oncology Group. Int J Radiat Oncol Biol Phys 42 (2): 269-76, 1998.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Benjamin Sischy, MD, FACR, Protocol chair (Contact information may not be current)
Ph: 716-341-6750

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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