NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001743

Registered date:02/03/2009

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

Basic Information

Recruitment status Suspended
Health condition(s) or Problem(s) studiedinoperable stage III non-small cell lung cancer
Date of first enrollment2009/03/01
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)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

Outcome(s)

Primary Outcome2-year survival rate
Secondary OutcomeResponse rate, overall survival, incidence of toxicity

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum74years-old
GenderMale and Female
Include criteria
Exclude criteria1. 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.

Related Information

Contact

public contact
Name Ikuo Sekine
Address Tsukiji 5-1-1, Chuo-ku, Tokyo Japan
Telephone 03-3542-2511
E-mail isekine@ncc.go.jp
Affiliation National Cancer Center Hospital Division of Internal Medicine and Thoracic Oncology
scientific contact
Name Tomohide Tamura
Address Tsukiji 5-1-1, Chuo-ku, Tokyo Japan
Telephone 03-3542-2511
E-mail
Affiliation National Cancer Center Hospital Division of Internal Medicine and Thoracic Oncology