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

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

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

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

Purpose: To evaluate the survival benefit of adjuvant chemotherapy after curative resection in serosa-positive gastric cancer patients, a multicenter phase III clinical trial was conducted by 13 participating centers in Japan. Methods: From January 1993 to March 1998, 268 patients were randomized to either adjuvant chemotherapy (135 pts) or surgery alone (133 pts). The chemotherapy comprised intraperitoneal cisplatin 70 mg/m2 before closing the abdomen, and after surgery intravenous cisplatin 70 mg/m2 (day 14) and 5-fluorouracil (5-FU) 700 mg/m2 daily (day 14-16), and oral FU (UFT) 267 mg/m2 daily from 4 weeks after surgery for the next 12 months. The primary endpoint was overall survival. Relapse-free survival and the site of recurrence were secondary endpoints. Comparison: gastrectomy with D2 or greater lymph node dissection versus gastrectomy with adjuvant chemotherapy after curative resection in serosa-positive gastric cancer patients.

gastric neoplasm, gastrectomy, adjuvant chemotherapy, randomized trial, T3 and T4 carcinoma of the stomach/Gastric Neoplasm

Inclusion Criteria: Curative operation with D2 or greater lymph node dissection Histologically proven gastric adenocarcinoma Macroscopically serosa-positive (T3-4) No metastases to level 3 - 4 lymph nodes station (N0-2) 75 years or younger Negative peritoneal lavage cytology Adequate organ function WBC >=4000/mm3,Hb >=11.0g/dl,Plt >=100.000/mm3,AST/ALT, T.Bil, BUN, Creatinine <=2.5 x Normal Upper Limit,Creatinine clearance <=70 ml/min Written informed consent Exclusion Criteria: Prior chemotherapy or radiotherapy Synchronous or metachronous malignancy in other organs

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.