[Interim report of JFMTC study no. 20 on the effectiveness of high dose CDDP plus 5-FU regimen as an adjuvant therapy for far-advanced cancer of the stomach]

Gan To Kagaku Ryoho. 2000 Mar;27(3):395-403.
[Article in Japanese]

Abstract

This interim analysis of the JFMTC study as of May, 1998 covers 321 gastrectomized patients with far-advanced stomach cancer from 135 institutions between November, 1993 and March, 1996. The intensive therapy group (I-group) received CDDP i.p. administration on resective surgery with 70 mg/m2 followed by CDDP i.v. of 80 mg/m2 (day 1, i.v.), accompanying 5-FU of 350 mg/m2/day (day 1-5, c.v.i.) in the 4th, 8th and 12th weeks. The I-group was randomly compared with the standard therapy group (S-group) of MMC of 6 mg/m2 i.v. in the 4th, 8th and 12th weeks and UFT of 3-4 capsules daily for postoperative one year. The results obtained were that 1. adverse reactions were found more in the I-group than in the S-group, particularly notable in the decrease in blood cells, loss of appetite and nausea/vomiting, and incidence of grade 3 or more being 13% (neutrophile leukocytes), 26% and 21%, respectively; 2. there was no significant difference between I- and S-groups in terms of 3-year survival or disease-free survival rates. (JFMTC: Japanese Foundation of Multidisciplinary Treatment for Cancer).

Publication types

  • Clinical Trial
  • English Abstract
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Cisplatin / administration & dosage
  • Drug Administration Schedule
  • Drug Evaluation
  • Fluorouracil / administration & dosage
  • Humans
  • Stomach Neoplasms / drug therapy*
  • Stomach Neoplasms / mortality
  • Survival Rate
  • Tegafur / administration & dosage
  • Uracil / administration & dosage

Substances

  • Tegafur
  • Uracil
  • Cisplatin
  • Fluorouracil

Supplementary concepts

  • 1-UFT protocol
  • CF regimen