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

Gastric Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00147147
• Other study ID #: JCOG9206-2
• Secondary ID: C000000067
• Status: Completed
• Phase: Phase 3
• First received: September 5, 2005
• Last updated: September 20, 2016
• Start date: January 1993
• Est. completion date: March 2004

Study information

• Verified date: September 2016
• Source: Japan Clinical Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Neoplasm
• Neoplasms
• Stomach Neoplasms

Intervention

Procedure:
• Gastrectomy with D2 or greater lymph node dissection

Drug:
• Gastrectomy+ chemotherapy

Locations

Country	Name	City	State
Japan	Gastric Surgery Division, National Cancer Center Hospital	Chuo-ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Japan Clinical Oncology Group	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival
Secondary	Relapse-free survival
Secondary	the site of recurrence

External Links

•   Link