Randomized phase II trial evaluating two paclitaxel and cisplatin-containing chemoradiation regimens as adjuvant therapy in resected gastric cancer (RTOG-0114) Journal Article

Authors: Schwartz, G. K.; Winter, K.; Minsky, B. D.; Crane, C.; Thomson, P. J.; Anne, P.; Gross, H.; Willett, C.; Kelsen, D.
Article Title: Randomized phase II trial evaluating two paclitaxel and cisplatin-containing chemoradiation regimens as adjuvant therapy in resected gastric cancer (RTOG-0114)
Abstract: 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. © 2009 by American Society of Clinical Oncology.
Keywords: adult; cancer survival; controlled study; treatment outcome; treatment response; aged; aged, 80 and over; middle aged; survival rate; major clinical study; clinical trial; cisplatin; fluorouracil; cancer combination chemotherapy; drug safety; skin toxicity; paclitaxel; adjuvant therapy; cancer adjuvant therapy; cancer patient; cancer radiotherapy; disease free survival; radiation dose; chemotherapy, adjuvant; combined modality therapy; follow-up studies; neoplasm staging; controlled clinical trial; liver toxicity; lung toxicity; multiple cycle treatment; nephrotoxicity; pain; phase 2 clinical trial; gastrointestinal symptom; randomized controlled trial; antineoplastic combined chemotherapy protocols; risk factors; continuous infusion; drug hypersensitivity; febrile neutropenia; cancer center; multicenter study; folinic acid; gastrectomy; stomach cancer; therapy effect; heart arrhythmia; drug dose regimen; stomach neoplasms; eye toxicity; bone marrow toxicity; bleeding tendency; ototoxicity
Journal Title: Journal of Clinical Oncology
Volume: 27
Issue: 12
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2009-04-20
Start Page: 1956
End Page: 1962
Language: English
DOI: 10.1200/jco.2008.20.3745
PUBMED: 19273696
PROVIDER: scopus
PMCID: PMC2669761
Notes: --- - "Cited By (since 1996): 2" - "Export Date: 30 November 2010" - "CODEN: JCOND" - "Source: Scopus"
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MSK Authors
  1. Gary Schwartz
    364 Schwartz
  2. Bruce Minsky
    264 Minsky
  3. David P Kelsen
    341 Kelsen