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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
History of Changes
  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:

Drug Information available for: Cisplatin
U.S. FDA Resources

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
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:
Related Info  This link exits the ClinicalTrials.gov site

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
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
 Adjuvants, Immunologic
Cisplatin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 19, 2013