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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by West Japan Thoracic Oncology Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
West Japan Thoracic Oncology Group
ClinicalTrials.gov Identifier:
NCT00139971
First received: August 30, 2005
Last updated: January 5, 2006
Last verified: August 2005
  Purpose

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 Intervention Phase
Lung Cancer
Drug: gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6
Drug: UFT 250mg/m2, daily for 1 year
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by West Japan Thoracic Oncology Group:

Primary Outcome Measures:
  • 5 year survival rate

Secondary Outcome Measures:
  • Disease free survival

Estimated Enrollment: 600
Study Start Date: December 2001
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139971

Contacts
Contact: Hirohito Tada, MD +81-6-6929-1221 htada@attglobal.net

Locations
Japan
Osaka City General Hospital Recruiting
Osaka, Japan, 531-0021
Contact: Hirohito Tada, MD    +81-6-6929-1221    htada@attglobal.net   
Principal Investigator: Hirohito Tada, MD         
Sponsors and Collaborators
West Japan Thoracic Oncology Group
Investigators
Principal Investigator: Hirohito Tada, MD West Japan Thoracic Oncology Group
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00139971     History of Changes
Other Study ID Numbers: WJTOG0101
Study First Received: August 30, 2005
Last Updated: January 5, 2006
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014