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)

UMIN ID: UMIN000001319

Registered date:18/08/2008

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: High grade pulmonary neuroendocrine carcinona (Large cell neuroendocrine carcinoma and small cell lung cancer)
• Date of first enrollment: 2007/09/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• 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 Outcome: the rate of completion of chemotherapy
• Secondary Outcome: 3-years overall survival 3-years relapse free survival Incidence of an adverse event

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) 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

• Primary Sponsor: Department Thoracic Oncology, National Cancer Center Hospital East
• Source(s) of Monetary Support: Department Thoracic Oncology, National Cancer Center Hospital East