Clincosm LogoSign in Get a demo

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

Sponsor
West Japan Thoracic Oncology Group (Other)
Overall Status
Unknown status
CT.gov ID
NCT00139971
Collaborator
(none)
600
Enrollment
1
Location

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6
  • Drug: UFT 250mg/m2, daily for 1 year
 Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Dec 1, 2001

Outcome Measures

Primary Outcome Measures

  1. 5 year survival rate []

Secondary Outcome Measures

  1. Disease free survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Osaka City General Hospital Osaka Japan 531-0021

Sponsors and Collaborators

  • West Japan Thoracic Oncology Group

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00139971
Other Study ID Numbers:
  • WJTOG0101
First Posted:
Aug 31, 2005
Last Update Posted:
Jan 6, 2006
Last Verified:
Aug 1, 2005
Additional relevant MeSH terms:
Lung Neoplasms
Gemcitabine

Study Results

No Results Posted as of Jan 6, 2006