Phase III study of Carboplatin/Paclitaxel versus UFT for the patient with completely resected pathological stage IB-IIIA of Non Small Cell Lung Cancer

Phase III study of Carboplatin/Paclitaxel versus UFT for the patient with completely resected pathological stage IB-IIIA of Non Small Cell Lung Cancer - Phase III study of Carboplatin/Paclitaxel versus UFT for the patient with completely resected pathological stage IB-IIIA of Non Small Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000810

Enrollment

400

Registered

2007-08-28

Start date

2004-02-01

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

Non Small Cell Lung Cancer

Interventions

adjuvant chemotherapy with CBDCA+PTX CBDCA: AUC=5, day1 PTX: 175mg/m2 day1 q3-4weeks adjuvant chemotherapy with UFT 250mg/m2/day for 2 years

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. pathologically proven non-small cell lung cancer 2. pathological stage IB, II, and stage IIIA with only one station of n2 disease 3. complete resection 4. at least lobectomy 5. adequate LN dissection (ND2a) 6. no prior anti cancer treatment for thoracic malignancy except for this operation 7. PS 0-1 8. adequate organ function for chemotherapy 9. written informed consent

Exclusion criteria

Exclusion criteria: 1. sever infection, uncontrolled Diabetes Mellitus, and hypertension 2. unstable angina or Myocardial Infarction within 6 months 3. apparent interstitial pneumonitis at chest rentogenogram 4. systemic steroid therapy required 5. uncontrolled cancer 6. Pregnant or expecting woman

Design outcomes

Primary

Measure	Time frame
survival	—

Countries

Japan

Contacts

Public ContactHiromasa Yamamoto

Okayama University Hospital Department of Thoracic Surgery

h.yamamoto@md.okayama-u.ac.jp086-235-7265

Outcome results

None listed

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