Trial | NCT00147147  Report issue

Title

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)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fluorouracil cisplatin ...

  • Study Participants

    280
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.
Study Started
Jan 31
1993
Study Completion
Mar 31
2004
Last Update
Sep 22
2016
Estimate

Procedure Gastrectomy with D2 or greater lymph node dissection

Drug Gastrectomy+ chemotherapy

Criteria 

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
No Results Posted