Phase III Study of Gemcitabine Compared With UFT in Patients With Completely Resected Pathological Stage IB-IIIa Non Small Cell Lung Cancer

January 5, 2006 updated by: West Japan Thoracic Oncology Group
To estimate the efficacy of Gemcitabine monotherapy compared to UFT as the post operative adjuvant chemotherapy for completely resected non-small cell lung cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka, Japan, 531-0021
        • Recruiting
        • Osaka City General Hospital
        • Contact:
        • Principal Investigator:
          • Hirohito Tada, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. completely resected non small cell lung cancer
  2. no prior anti cancer treatment for thoracic malignancy exept for this operation
  3. pathological stage IB, II, and stage IIIA with only one station of n2 disease
  4. PS 0-1
  5. age 20-75
  6. adequate organ function for chemotherapy
  7. written informed consent

Exclusion Criteria:

  1. small cell lung cancer or low grade malignancy of lung cancer
  2. incomplete resection
  3. apparent interstitial pneumonitis at chest rentogenogram
  4. inadequate condition for chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
5 year survival rate

Secondary Outcome Measures

Outcome Measure
Disease free survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West Japan Thoracic Oncology Group

Investigators

  • Principal Investigator: Hirohito Tada, MD, West Japan Thoracic Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

August 30, 2005

First Submitted That Met QC Criteria

August 30, 2005

First Posted (Estimate)

August 31, 2005

Study Record Updates

Last Update Posted (Estimate)

January 6, 2006

Last Update Submitted That Met QC Criteria

January 5, 2006

Last Verified

August 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WJTOG0101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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