Originally published as JCO Early Release 10.1200/JCO.2008.20.3745 on March 9 2009

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Randomized Phase II Trial Evaluating Two Paclitaxel and Cisplatin–Containing Chemoradiation Regimens As Adjuvant Therapy in Resected Gastric Cancer (RTOG-0114)

From the Memorial Sloan-Kettering Cancer Center, New York, NY; Radiation Therapy Oncology Group Statistical Office; Thomas Jefferson University, Philadelphia, PA; M. D. Anderson Cancer Center, Houston, TX; Latter Day Saints Hospital, Salt Lake City, UT; Dayton Community Clinical Oncology Program, Dayton, OH; and Duke University Comprehensive Cancer Center, Durham, NC.

Corresponding author: Gary K. Schwartz, MD, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, New York, NY 10021; e-mail: schwartg{at}mskcc.org.

Purpose The investigational arm of INT0116, a fluorouracil (FU) and leucovorin–containing chemoradiotherapy regimen, is a standard treatment for patients with resected gastric cancer with a 2-year disease-free survival rate (DFS) of 52%. Toxicity is also significant. More beneficial and safer regimens are needed.

Patients and Methods We performed a randomized phase II study among 39 cancer centers to evaluate two paclitaxel and cisplatin–containing regimens, one with FU (PCF) and the other without (PC) in patients with resected gastric cancer. Patients received two cycles of postoperative chemotherapy followed by 45 Gy of radiation with either concurrent FU and paclitaxel or paclitaxel and cisplatin. The primary objective was to show an improvement in 2-year DFS to 67% as compared with INT 0116.

Results From May 2001 to February 2004 (study closure), 78 patients entered this study, and 73 were evaluable. At the planned interim analysis of 22 patients on PCF, grade 3 or higher GI toxicity was 59%. This was significantly worse than INT0116, and this arm was closed. Accrual continued on PC. The median DFS was 14.6 months for PCF and has not been reached for PC. For PC the 2-year DFS is 52% (95% CI, 36% to 68%).

Conclusion Though PC appears to be safe and the median DFS favorable, the DFS failed to exceed the lower bound of 52.9% for the targeted 67% DFS at 2 years and can not be recommended as the adjuvant arm for future randomized trials.

Supported by Radiation Therapy Oncology Group U10 Grant No. CA21661, and by the National Cancer Institute Grants No. CCOP U10 CA37422 and Stat U10 CA32115.

Presented in part at the 41st Annual Meeting of the American Society of Clinical Oncology, May 13-15, 2005, Orlando, Florida.

This manuscript's contents are the sole responsibility of the authors and do not necessarily represent the official views of the NCI.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical Trials repository link available on JCO.org.

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