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NCT Number: NCT00142350

A Study of 5-FUci Versus CPT-11 Plus CDDP Versus S-1 Alone in Advanced Gastric Cancer

To investigate the superiority of a combination of irinotecan and cisplatin and the non-inferiority of S-1 compared to continuous infusion of 5-FU in advanced gastric cancer

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Key information

Conditions

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

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aichi Cancer Center Hospital, Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan

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About this study

From the results of our previous phase III study (JCOG9205), continuous infusion of 5-fluorouracil has remained to be a control arm of this study. This study investigates the superiority of a combination of irinotecan plus cisplatin and non-inferiority of S-1, a oral fluoropyrimidine, compared to continuous infusion of 5-fluorouracil at the point of overall survival, and the planned number of enrolled patients is 690 (230/arm).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • unresectable or recurrent histologically proved gastric cancer
  • adequate oral intake
  • age 20 or older and 75 or younger
  • Performance Status (ECOG):0, 1, 2
  • measurable or unmeasurable lesions
  • preserved organ functions
  • no severe medical condition
  • no prior chemotherapy for gastric cancer
  • written informed consent

Exclusion criteria

  • patient with marked infection or inflammation
  • patient with severe peritoneal metastasis
  • patient with massive pleural effusion
  • patient with metastasis to CNS
  • patient with diarrhea 4 or more times per day
  • patient severe medical condition
  • patient with other concurrent malignancy affecting on survival or adverse events
  • pregnant or nursing patient or with intent to bear baby
  • patient evaluated to be inadequate by a attending doctor
  • patient requiring nutritional support

Treatment and study plan

continuous infusion of 5-fluorouracil

Drug

combination of irinotecan and cisplatin

Drug

oral administration of S-1

Drug

Primary outcomes

  1. overall survival

Secondary outcomes

  1. time to treatment failure

  2. incidences of adverse events

  3. response rate

  4. non-hospitalized survival

Sponsors and collaborators

Lead sponsor

Japan Clinical Oncology Group

Other

Collaborators

  • Ministry of Health, Labour and Welfare, Japan
  • Taiho Pharmaceutical Co., Ltd.
  • Yakult Honsha Co., LTD

Registry information

Official study title

Randomized Phase III Study of 5-FU Continuous Infusion (5-FUci) Versus CPT-11 Plus CDDP (CP) Versus S-1 Alone (S-1) in Advanced Gastric Cancer (JCOG9912)

Important dates

Study start
2000
Study completion
2007
First posted
Sep 2, 2005
Registry last updated
Sep 12, 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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