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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Closed	no age specified		GITSG-8376 MAYO-764101

Objectives

I.  Compare four regimens:  FIMe (5-fluorouracil/ICRF-159/methyl CCNU) vs. FAM 
(5-fluorouracil/adriamycin/mitomycin-C) vs. FAMe (5-fluorouracil/methyl 
CCNU/adriamycin) vs. 5-fluorouracil/methyl CCNU (Addendum, September 1976) for 
their effectiveness against advanced nonresectable gastric carcinoma.  For the 
September 1978 Revision of this study, see GITSG-8376R.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Histologically proven residual, 
recurrent, or metastatic primary gastric adenocarcinoma with measurable tumor 
parameters.  Allow three weeks minimum recovery interval following any major 
surgical procedure involving resection or bypass, two weeks from exploration 
and biopsy only, and 4 weeks from any previous radiation or chemotherapy.  
Patients with locally unresectable disease may be entered, patients with heart 
disease or prior chemotherapy are no longer eligible, Addendum 5, September 
1978.

Expected Enrollment

260 patients will be entered in approximately 2 years.  Study revised 
September 1978; see GITSG-8376R.  Protocol closed March 1981.

Outline

Randomized study.
Induction:
Randomize patients previously treated with ADR to Arms I and IV only.  
Randomize patients previously treated with MITO to Arms I, III or IV.  
Randomize patients with active heart disease and no prior therapy with 5-FU, 
ICRF-159 or MeCCNU to Arms I or IV.  Assign patients with prior nitrosourea 
therapy to Arm II.  Arm IV is to be assigned less frequently, using an 
imbalanced randomization assignment ratio of 3:3:3:2.
Arm I:  3-Drug Combination Chemotherapy.  FIMe:  5-Fluorouracil, 5-FU, 
NSC-19893; ICRF-159, NSC-129943; Methyl CCNU, MeCCNU, NSC-95441.  (Arm closed, 
Addendum 5, September 1978.
Arm II:  3-Drug Combination Chemotherapy.  FAM:  5-FU; Adriamycin, ADR, 
NSC-123127; Mitomycin-C, NSC-26980.  (Arm closed for locally unresectable 
patients, Addendum 1, January 1979).
Arm III:  3-Drug Combination Chemotherapy.  FAMe:  5-FU; ADR; MeCCNU.
Arm IV:  2-Drug Combination Chemotherapy.  5-FU; MeCCNU.  (Arm deleted 
Addendum, 5, September 1978, reopened for locally unresectable patients, 
Addendum, 2, January 1979.
Arm IVA:  2-Drug Combination Chemotherapy.  5-FU, ADR.  (Arm added, Addendum 5 
September, 1978).  Enter 2 patients to each patient entered in Arms II and III.
Maintenance:  Enter patients responding to Induction therapy.
Arm V:  Enter responders to Arm I.  Alternate 3-Drug Combination Chemotherapy 
with 2-Drug Combination Therapy.  5-FU, ICRF-159, MeCCNU alternating with 
ICRF-159, 5-FU.
Arm VI:  Enter responders to Arm II.  Alternate 3-Drug Combination 
Chemotherapy with 2-Drug Combination Therapy.  5-FU, ADR, MITO alternating 
with 5-FU, ADR.
Arm VII:  Enter responders to Arm III.  Alternate 3-Drug Combination 
Chemotherapy with 2-Drug Combination Chemotherapy.  5-FU, MeCCNU, ADR 
alternating with 5-FU, ADR.
Arm VIII:  Enter responders to Arm IV.  2-Drug Combination Chemotherapy.  
5-FU, MeCCNU.

Randomized study of combination chemotherapy in unresectable gastric cancer. The Gastrointestinal Tumor Study Group. Cancer 53 (1): 13-7, 1984.[PUBMED Abstract]

A comparative clinical assessment of combination chemotherapy in the management of advanced gastric carcinoma: The Gastrointestinal Tumor study Group. Cancer 49 (7): 1362-6, 1982.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gastrointestinal Tumor Study Group

Harold Douglass, MD, FACS, Protocol chair(Contact information may not be current)		Ph: 716-845-5738; 800-685-6825 Email: harold.douglass@roswellpark.org