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NCT Number: NCT00147147

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

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

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Key information

Conditions

Gastric Neoplasm Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gastric Surgery Division, National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • Prior chemotherapy or radiotherapy
  • Synchronous or metachronous malignancy in other organs

Treatment and study plan

Gastrectomy with D2 or greater lymph node dissection

Procedure

Gastrectomy+ chemotherapy

Drug

Primary outcomes

  1. Overall survival

Secondary outcomes

  1. Relapse-free survival

  2. the site of recurrence

Sponsors and collaborators

Lead sponsor

Japan Clinical Oncology Group

Other

Collaborators

  • Ministry of Health, Labour and Welfare, Japan

Registry information

Official study title

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

Important dates

Study start
1993
Study completion
2004
First posted
Sep 7, 2005
Registry last updated
Sep 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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