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

West Japan Thoracic Oncology Group

Status and phase: Unknown; Phase 3

Conditions: Lung Cancer

Treatments: Drug: UFT 250mg/m2, daily for 1 year; Drug: gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6

Study type: Interventional

Funder types: Other

Identifiers

NCT00139971

WJTOG0101

Details and patient eligibility

About

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

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)