Current Clinical Trials at UIHC: GI Oncology Protocols: Resected Gastric Ca.
James R. Howe, M.D.
Peer Review Status: Internally Peer
Reviewed
Objective:
Previous studies have shown conflicting results for adjuvant and neoadjuvant treatment. Generally it appears that chemotherapy alone as an adjuvant does not confer a survival advantage. This has been shown in the VASOG (Cancer 52:1105, 1983) and ECOG trials (Cancer 55:1868, 1985), while the GITSG trial showed a modest benefit for 5-FU/mCCNU (59% vs. 44% survival at 4 yr. median F/U; Cancer 49:1116, 1982). Preliminary data from FAM trials (SWOG, MAOP) does not show a survival benefit at 3 years (Proc. Am. Soc. Clin. Oncol.).
Since 80-85% of patients who recurr have evidence of locoregional failure, 20-33% have distant metastases, but only 5% have isolated metastases (Int. J. Radiation Oncol. Biol. Phys. 8:1, 1982), radiation therapy might be useful in preventing some of these recurrences. Studies combining chemotherapy/radiation versus chemotherapy as an adjuvant alne have demonstrated a survival benefit in the chemo/XRT arm (Cancer 49:1771, 1982).
All pts. must have en bloc resection of all known tumor, but those with metastatic disease are excluded.
The chemotherapy regimen consists of 5-FU (425 mg/m2/d days 1-5) and Leucovorin (20 mg/m2/d days 1-5), followed by XRT to 4500 cGY with chemotherapy given weeks 1 and 5, then 2 subsequent courses (at 4 wk. interval) of chemotherapy after radiation.
Projected accrual is 550 pts., and over 51 months 404 pts. were entered. Closure is anticipated in January 1997.
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