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Completed

NCT Number: NCT00195572

Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer

The purpose of the study is to verify non-inferiority of survival time between Isovorin/5-fluorouracil (1-LV/5FU) therapy and TS-1 therapy in patients with inoperable advanced or recurrent gastric cancer. Secondary endpoints include response rates, duration of responses, time to progression (TTP) safety and quality of life (QOL).

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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–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Adachi-ku, Tokyo, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Gastric cancer diagnosed histologically or cytologically
  • Normal organ function of bone marrow, heart, liver and kidney
  • Age of 20-77

Other inclusion applies

Exclusion criteria

  • Serious infection, heart disease, complication or organ disorder
  • Ongoing administration of flucytosine
  • Pregnant or breastfeeding women

Other exclusion applies

Treatment and study plan

Isovorin

Drug

TS-1

Drug

Primary outcomes

  1. Survival time

Secondary outcomes

  1. Response rate, duration of response, time to progression, safety, quality of life

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

Post-Approved Phase III Study of 1-LV/5FU Therapy

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Sep 19, 2005
Registry last updated
Aug 13, 2009

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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