NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000002015

Registered date:30/06/2009

Randomized phase III study of nedaplatin plus docetaxel versus cisplatin plus docetaxel for advanced or relapsed squamous cell carcinoma of the lung

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedsquamous cell carcinoma of the lung
Date of first enrollment2009/07/01
Target sample size350
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Nedaplatin at 100mg/m2 plus docetaxel at 60mg/m2 are administered every three weeks. Each three-week treatment schedule is designed as one cycle, and a total of 4 to 6 cycles are administered. Cisplatin at 80mg/m2 plus docetaxel at 60mg/m2 are administered every three weeks. Each three-week treatment schedule is designed as one cycle, and a total of 4 to 6 cycles are administered.

Outcome(s)

Primary OutcomeOverall survival
Secondary OutcomeProgression free survival, response rate and adverse events

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1)Symptomatic brain metastasis or brain metastasis which needs treatment like adrenal corticosteroids or antiepileptic drugs. 2)Other current active malignancy. 3)Superior vena cava syndrome. 4)Malignant pericardial/ pleural/ peritoneal effusion which need continuous drainage or rapidly increase after temporary drainage. 5)Patient has received radiotherapy to the primary lesion. 6)Patient received palliative radiotherapy except to the primary lesion in last 2 weeks. 7)Patient has a clinically significant con current illness. 8)Interstitial pneumonia or pulmonary fibrosis documented obviously in chest X ray. 9)Pregnant or breast-feeding woman or patient who doesn't agree to contraception. 10)Patient has a history of severe allergy or hypersensitivity. 11)Any other reason that, in the opinion of the investigator, precludes the subject from participating in the study.

Related Information

Contact

public contact
Name Shinichiro Nakamura
Address Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN Japan
Telephone 06-6633-7400
E-mail datacenter@wjog.jp
Affiliation West Japan Oncology Group WJOG datacenter
scientific contact
Name Nobuyuki Yamamoto
Address 1007 Shimonagakubo, Nagaizumi-chou, Suntou-gun, Shizuoka, 411-8777, Japan Japan
Telephone 055-989-5222
E-mail nbyamamo@wakayama-med.ac.jp
Affiliation Shizuoka Cancer Center Division of Thoracic Oncology