Randomized phase II trial of UFT plus Cisplatin versus Pemetrexed plus Cisplatin combined with Concurrent Thoracic Radiotherapy in Locally Advanced Non-Small-Cell Lung Cancer. North Japan Lung Cancer Study Group Trial 1001 (NJLCG1001)

Randomized phase II trial of UFT plus Cisplatin versus Pemetrexed plus Cisplatin combined with Concurrent Thoracic Radiotherapy in Locally Advanced Non-Small-Cell Lung Cancer. North Japan Lung Cancer Study Group Trial 1001 (NJLCG1001) - RDM PII UFT+CDDP+RT vs PEM+CDDP+RT NJLCG1001

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003948

Enrollment

Registered

2010-07-31

Start date

2010-08-01

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

Patients receive UFT (400mg/m2 per os) on day 1-14 and cisplatin (80mg/m2 div) on day8 every 3 weeks up to 3 cycles combined with concurrent thoracic radiotherapy (66Gy/33Fr) Patients receive pemetrex

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Non-squamous non-small-cell lung cancer 2) Chemotherapy-naive 3) Radiotherapy-naive 4) Unresectable locally advanced clinical stage IIIA or IIIB 5) ECOG-PS 0 or 1 6) Measurable lesion by RECIST ver.1.1 criteria 7) Adequate organ function 8) Life expectancy more than 3 months 9) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Clinically active interstitial pneumonia or pulmonary fibrosis, detectable on CT scan 2) Malignant pleural or pericardial effusion or ascites 3) Severe co-morbidities (ex. uncontrolled heart or lung or hepatic or renal disease or diabetes) 4) Regular use of corticosteroid (less than 2 weeks interval after cessation) 5) Pregnancy or lactation, or those who decline contraception 6) Contraindication with chemotherapy or radiotherapy 7) Active concomitant malignancy. Except carcinoma in situ or those who did not relapse 5-years or more 8) Those judged to be not suitable by the attending physician

Design outcomes

Primary

Measure	Time frame
Two-years survival rate	—

Secondary

Measure	Time frame
response rate, progression free survival, overall survival, adverse events	—

Countries

Japan

Contacts

Public ContactAkira Inoue

Tohoku University Hospital Dept. of Respiratory Medicine

akinoue@idac.tohoku.ac.jp

Outcome results

None listed

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