randomized study of Gemicitabine alone or UFT adjuvant chemotherapy for stage IB-IIIA non small cell lung cancer after complete resection

randomized study of Gemicitabine alone or UFT adjuvant chemotherapy for stage IB-IIIA non small cell lung cancer after complete resection - randomized study of Gemicitabine alone or UFT adjuvant chemotherapy for stage IB-IIIA non small cell lung cancer after complete resection

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000116

Enrollment

600

Registered

2005-09-06

Start date

2001-06-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

stage IB-IIIA non small cell lung cancer after complete resection

Interventions

experimental arm: gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6 cycle standard arm: UFT 250mg/m2, daily for 1 year

Eligibility

Sex/Gender

All

Inclusion 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 oragan function for chemotherapy 7.written informed consent

Exclusion criteria

Exclusion criteria: 1.small cell lung cancer or low grade malignancy of lung cancer 2.incomplete resection 3.apparant interstitial pneumonitis at chest rentogenogram 4.inadequate conditon for chemotherapy

Design outcomes

Primary

Measure	Time frame
overall survival	—

Countries

Japan

Contacts

Public ContactShinichiro Nakamura

West Japan Oncology Group WJOG datacenter

datacenter@wjog.jp06-6633-7400

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026