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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00147147
First received: September 5, 2005
Last updated: August 9, 2006
Last verified: August 2006
  Purpose

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


Condition Intervention Phase
Gastric Neoplasm
Procedure: Gastrectomy with D2 or greater lymph node dissection
Drug: Gastrectomy+ chemotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of Adjuvant Chemotherapy With Cisplatin Followed by Oral Fluorouracil (UFT) in Serosa-Positive Gastric Cancer (JCOG9206-2)

Resource links provided by NLM:


Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • Overall survival

Secondary Outcome Measures:
  • Relapse-free survival
  • the site of recurrence

Estimated Enrollment: 280
Study Start Date: January 1993
Estimated Study Completion Date: March 2004
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 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.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00147147

Locations
Japan
Gastric Surgery Division, National Cancer Center Hospital
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan, 104-0045
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Hiroshi Furukawa, MD, PhD Sakai Municipal Hospital
  More Information

Additional Information:
No publications provided by Japan Clinical Oncology Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00147147     History of Changes
Other Study ID Numbers: JCOG9206-2, C000000067
Study First Received: September 5, 2005
Last Updated: August 9, 2006
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:
gastric neoplasm
gastrectomy
adjuvant chemotherapy
randomized trial
T3 and T4 carcinoma of the stomach/Gastric Neoplasm

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms by Site
Stomach Diseases

ClinicalTrials.gov processed this record on October 29, 2014