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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00139971

Enrollment

600

Registered

2005-08-31

Start date

2001-12-31

Completion date

Unknown

Last updated

2006-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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.

Interventions

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

DRUGUFT 250mg/m2, daily for 1 year

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
5 year survival rate	—

Secondary

Measure	Time frame
Disease free survival	—

Countries

Japan

Contacts

Primary ContactHirohito Tada, MD

htada@attglobal.net+81-6-6929-1221

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026