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)
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.
Inclusion Criteria:

 1. Curative operation with D2 or greater lymph node dissection

 2. Histologically proven gastric adenocarcinoma

 3. Macroscopically serosa-positive (T3-4)

 4. No metastases to level 3 - 4 lymph nodes station (N0-2)

 5. 75 years or younger

 6. Negative peritoneal lavage cytology

 7. 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

 8. Written informed consent

 Exclusion Criteria:

 1. Prior chemotherapy or radiotherapy

 2. Synchronous or metachronous malignancy in other organs