Phase II study of high-dose thoracic 3D-conformal radiotherapy without elective nodal irradiation concurrently combined with cisplatin and vinorelbine chemotherapy in patients with inoperable stage III non-small cell lung cancer

Phase II study of high-dose thoracic 3D-conformal radiotherapy without elective nodal irradiation concurrently combined with cisplatin and vinorelbine chemotherapy in patients with inoperable stage III non-small cell lung cancer - Phase II study of high-dose thoracic and cisplatin and vinorelbine for stage III NSCLC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001743

Enrollment

Registered

2009-03-02

Start date

2009-03-01

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

inoperable stage III non-small cell lung cancer

Interventions

Cisplatin 80mg/m2 on day 1 + vinorelbine 20mg/m2 on days 1 and 8, repeated every 4 weeks for 4 cycles, Thoracic radiotherapy 72 Gy/36 fractions

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. a histological or cytological diagnosis of NSCLC; 2. inoperable clinical stage III; 3. no prior treatment; 4. measurable disease; 5. the percent volume of the normal lung receiving 20 Gy or more (V20) equal to or less than 30%; 6. age between 20 and 74 years; 7. Performance Status of 0 - 1; 8. adequate organ function; and 9. written informed consent.

Exclusion criteria

Exclusion criteria: 1. malignant pleural or pericardial effusion; 2. contralateral hilar lymph node metastasis, intralobular metastasis or lymphangitis carcinomatosa; 3. serious concomitant medical illness; 4. synchronous active malignancies; 5. history of chemotherapy or thoracic radiotherapy; 6. pregnancy or breast feeding.

Design outcomes

Primary

Measure	Time frame
2-year survival rate	—

Secondary

Measure	Time frame
Response rate, overall survival, incidence of toxicity	—

Countries

Japan

Contacts

Public ContactIkuo Sekine

National Cancer Center Hospital Division of Internal Medicine and Thoracic Oncology

isekine@ncc.go.jp03-3542-2511

Outcome results

None listed

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