A Phase II Study of Combination Chemotherapy using TS-1 and Cisplatin with Concurrent Thoracic Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer

A Phase II Study of Combination Chemotherapy using TS-1 and Cisplatin with Concurrent Thoracic Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer - Cis/TS-1 radiation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001370

Enrollment

Registered

2008-09-12

Start date

2006-11-01

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

Locally Advanced Non-Small Cell Lung Cancer

Interventions

Cisplatin+TS-1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologicaly or cytologicaly proven NSCLC 2.Un-treated patients with measurable (more than 10mm by CT or MRI) IIIA/IIIB NSCLC. 3.the case can eat. 4.When radio-oncologist judged that the patients can tolerable for full dose irradiation. 5.age under than 75 6.PS (ECOG) 0 to 1 7.Organ functions are met for this study. 8.WBC:4000/mm3 9.Neut: 2,000/mm3 10.Hb: 9.5 g/dl 11.PLT: 100,000/mm3 12.AST,ALT: 100 IU/L 13.T-bil: 1.5 mg/dL 14.Crea: 1.2 mg/dL 15.(Cockcroft-Gault):60 mL/min 16.PaO2: 70 torr 17.with written informed consent from patients.

Exclusion criteria

Exclusion criteria: 1.with Superior vena cava syndrome 2.with sever allergy 3.on going other studies or treating with uncomfortable drugs to TS-1 and cisplatin 4.contra hilar lymph nod swelling, pleural or cardiac effusion dew to cancer, lymphangitis carcinomatoses, T3N1M0 5.with sever infection, bleeding, cardiac diseases. 6.with continues diarrhea 7.ileus or sub-ireus 8.with interstitial pneumonia, sever COPD 9.Presence of other active malignancy 10.un-controlled DM 11.Uncontrolled psychiatric disease. 12.pregnancy or lactating patients 13.Others

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Toxicity, overall survival, progression free survival, the rate of treatment success, The comparison of monitor units at the reference points with or without inhomogeneity corrections.	—

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