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

Japan Clinical Oncology Group

Status and phase: Completed; Phase 3

Conditions: Gastric Neoplasm

Treatments: Drug: Gastrectomy+ chemotherapy; Procedure: Gastrectomy with D2 or greater lymph node dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT00147147

C000000067

JCOG9206-2

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)