Randomized Trial of Adjuvant Chemotherapy With Cisplatin Followed by UFT in Serosa-positive Gastric Cancer (JCOG9206-2)

Phase 3 Completed 280 enrolled Japan Clinical Oncology Group Ministry of Health, Labour and Welfare, Japan · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

To evaluate the survival benefit of adjuvant chemotherapy after curative resection with D2 or greater lymph node dissection in T3-4 gastric cancer patients.

Timeline

Start: 1993-01
Primary completion: —
Completion: 2004-03

Outcome

Missed primary endpoint

paper There was no significant difference in 5-year overall survival (62.0% adjuvant chemotherapy vs. 60.9% surgery-alone, P = 0.482) PMID 21336855 ↗

Publications

Miyashiro I, Furukawa H, Sasako M, Yamamoto S, Nashimoto A, Nakajima T, Kinoshita T, Kobayashi O, Arai K; Gastric Cancer Surgical Study Group in the Japan Clinical Oncology Group. Randomized clinical trial of adjuvant chemotherapy with intraperitoneal and intravenous cisplatin followed by oral fluorouracil (UFT) in serosa-positive gastric cancer versus curative resection alone: final results of the Japan Clinical Oncology Group trial JCOG9206-2. Gastric Cancer. 2011 Aug;14(3):212-8. doi: 10.1007/s10120-011-0027-3. Epub 2011 Feb 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	70 mg/m2	Intrathecal
Subject	UFT	Unknown	267 mg/m2	Oral
Subject	fluorouracil	Small molecule	700 mg/m2	Intravenous