NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001319

Registered date:18/08/2008

A pilot study of adjuvant chemotherapy with cisplatin and irinotecan for High grade pulmonary neuroendocrine carcinona (Large cell neuroendocrine carcinoma and small cell lung cancer)

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedHigh grade pulmonary neuroendocrine carcinona (Large cell neuroendocrine carcinoma and small cell lung cancer)
Date of first enrollment2007/09/01
Target sample size40
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)cisplatin 60mg/m2 on day 1 irinotecan 60mg/m2 on days 1,8 and 15 start within 4-10 weeks after surgery q4weeks,4 courses

Outcome(s)

Primary Outcomethe rate of completion of chemotherapy
Secondary Outcome3-years overall survival 3-years relapse free survival Incidence of an adverse event

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1) prior radiotherapy 2) active concomitant malignancy 3) with uncontrolled pleural/pericardial effusion 4) with interstitial pneumonia or pulmonary fibrosis as determined by chest x-ray 5) watery diarrhea 6) intestinal obstruction or paralysis 7) symptomatic brain metastasis 8) with serious complications .cardiac failure, stenocardia, and myocardial infarction within the previous 3 months .uncontrolled diabetes mellitus and hypertension .uncontrolled infection 9) pregnant or lactating women 10) psychological disease deemed unacceptable for inclusion to the study 11) with severe drug allergy 12) doctor's decision not to be registered to this study

Related Information

Contact

public contact
Name Kaoru Kubota
Address 6-5-1, Kashiwanoha, Kashiwa-shi, Chiba 277-8577, Japan Japan
Telephone 04-7133-1111
E-mail
Affiliation National cancer center east Thoracic Oncology Division
scientific contact
Name Kanji Nagai
Address 6-5-1, Kashiwanoha, Kashiwa-shi, Chiba 277-8577, Japan Japan
Telephone 04-7133-1111
E-mail
Affiliation National cancer center east Thoracic Surgery Division