A randomized phase II study of TS-1+Cisplatin versus Vinorelbine+Cisplatin,with thoracic radiotherapy for locally advanced non-small cell lung cancer.

A randomized phase II study of TS-1+Cisplatin versus Vinorelbine+Cisplatin,with thoracic radiotherapy for locally advanced non-small cell lung cancer. - A randomized phase II study of TS-1+Cisplatin versus Vinorelbine+Cisplatin,with thoracic radiotherapy for locally advanced non-small cell lung cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002420

Enrollment

110

Registered

2009-09-10

Start date

2009-09-01

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

TS-1+Cisplatin+ radiation VNR+ Cisplatin+ radiation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Histologically or cytologically confirmed NSCLC -No prior chemotherapy, radiotherapy or surgery (Open biopsy is allowed). -Unresectable lung cancer Stage 3A or 3B. -V20 <= 35% -Oral intake is possible -Adult patients (>=20,<75 years of age) -ECOG performance status 0 or 1 -Adequate organ function. -Laboratory values must be as follows; WBC count >= 4,000/mm3, Neutrophil count >= 2,000/mm3 hemoglobin >= 9.5g/dL, Platelet count >= 100,000/mm3 AST and ALT <= 100IU/LBilirubine level <= 1.5 mg/dL, Serum creatinine <= 1.5 mg/dL Creatinine clearance >= 60 mL/min, PaO2 >= 70 torr -Patients must sign an informed consent.

Exclusion criteria

Exclusion criteria: -T3N1 -SVC syndrome. -Clinically significant pleural or pericardial effusion,Contralateral Hilar lymph node metastasis, -Patients with concurrent serious infections or complications -Continuous watery diarrhea -Paralysis of the intestine, or ileus -Significant interstitial pneumonitis ,pulmonary fibrosis or severe emphysema in Chest Xp -The presence of other concomitant cancers -Concomitant therapy with another new anticancer drug, phenytoin, warfarin or flucytocine -Inadequately controlled diabetes mellitus -HBs Ag is positive -A history of serious drug allergy -Mental disease or psychotic manifestation -Pregnancy,breast feeding or wish of future bearing -Other conditions not suitable for this study

Design outcomes

Primary

Measure	Time frame
2 year survival rate	—

Secondary

Measure	Time frame
Over all survival, Progression free survival, Compliance rate of protocol regimen, Adverse event	—

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