Status:
COMPLETED
Randomized Trial of Adjuvant Chemotherapy With Cisplatin Followed by UFT in Serosa-positive Gastric Cancer (JCOG9206-2)
Lead Sponsor:
Japan Clinical Oncology Group
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Gastric Neoplasm
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE3
Brief 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.
Detailed 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 parti...
Eligibility Criteria
Inclusion
- 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
- Prior chemotherapy or radiotherapy
- Synchronous or metachronous malignancy in other organs
Key Trial Info
Start Date :
January 1 1993
Trial Type :
INTERVENTIONAL
End Date :
March 1 2004
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00147147
Start Date
January 1 1993
End Date
March 1 2004
Last Update
September 22 2016
Active Locations (1)
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1
Gastric Surgery Division, National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045