CLINICAL TRIAL
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, U.S. GOV'T, P.H.S.
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The concept of locally advanced gastric cancer. Effect of treatment on outcome. The Gastrointestinal Tumor Study Group.

Cancer 1990 December 2
In previous Gastrointestinal Tumor Study Group (GITSG) reports, gastric cancer patients with locally unresectable disease, treated with combined radiation and chemotherapy had a shorter median survival (40 weeks) but more remained alive at 4 years (18%) when compared to those randomized to receive chemotherapy alone (76 weeks and 6%, respectively). To further test the concept that combined modality therapy might increase the number of long-term survivors, a second protocol was designed, but with three major modifications. A course of chemotherapy would precede the 5-fluorouracil-potentiated radiation therapy. Doxorubicin would be added to the 5-fluorouracil plus methyl-CCNU combination. Radiation therapy would be given as a single course of 4320 cGy, with 5-fluorouracil given daily for 3 days at the beginning and end of the course. Median survival of 46 patients treated with chemotherapy alone was 59 weeks, with 11% alive after 3 years. Following combined modality therapy, median survival was 62 weeks, but only 7% lived 3 years. Although the problem of early deaths in the combined modality group was resolved, long-term survival with combination therapy was not demonstrated in this study.

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