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

Primary Purpose

Lung Cancer

Status

Unknown status

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6

UFT 250mg/m2, daily for 1 year

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: completely resected non small cell lung cancer no prior anti cancer treatment for thoracic malignancy exept for this operation pathological stage IB, II, and stage IIIA with only one station of n2 disease PS 0-1 age 20-75 adequate organ function for chemotherapy written informed consent Exclusion Criteria: small cell lung cancer or low grade malignancy of lung cancer incomplete resection apparent interstitial pneumonitis at chest rentogenogram inadequate condition for chemotherapy

Sites / Locations

Osaka City General HospitalRecruiting

Outcomes

Primary Outcome Measures

5 year survival rate

Secondary Outcome Measures

Disease free survival

Full Information

NCT ID

NCT00139971

First Posted

August 30, 2005

Last Updated

January 5, 2006

Sponsor

West Japan Thoracic Oncology Group

1. Study Identification

Unique Protocol Identification Number

NCT00139971

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2005

Overall Recruitment Status

Unknown status

Study Start Date

December 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

West Japan Thoracic Oncology Group

4. Oversight

5. Study Description

Brief Summary

To estimate the efficacy of Gemcitabine monotherapy compared to UFT as the post operative adjuvant chemotherapy for completely resected non-small cell lung cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

600 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6

Intervention Type

Drug

Intervention Name(s)

UFT 250mg/m2, daily for 1 year

Primary Outcome Measure Information:

Title

5 year survival rate

Secondary Outcome Measure Information:

Title

Disease free survival

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hirohito Tada, MD

Phone

+81-6-6929-1221

htada@attglobal.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hirohito Tada, MD

Organizational Affiliation

West Japan Thoracic Oncology Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

Osaka City General Hospital

City

Osaka

ZIP/Postal Code

531-0021

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hirohito Tada, MD

Phone

+81-6-6929-1221

htada@attglobal.net

First Name & Middle Initial & Last Name & Degree

Hirohito Tada, MD

12. IPD Sharing Statement

Links:

URL

http://www.wjtog.org/

Description

Related Info

Learn more about this trial

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

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