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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:
ClinicalTrials.gov Identifier:
NCT00147147
First Posted: September 7, 2005
Last Update Posted: September 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00147147


Locations
Japan
Gastric Surgery Division, National Cancer Center Hospital
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:
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
First Submitted: September 5, 2005
First Posted: September 7, 2005
Last Update Posted: September 22, 2016
Last Verified: September 2016

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
Cisplatin
Antineoplastic Agents