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)

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) - 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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001319

Enrollment

Registered

2008-08-18

Start date

2007-09-01

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

High grade pulmonary neuroendocrine carcinona (Large cell neuroendocrine carcinoma and small cell lung cancer)

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)be able to start chemotherapy within 4-10 weeks after surgery 2) histologically confirmed large cell neuroendocrine carcinoma and small cell lung cancer, completely resected, pathological stage IA, IB, IIA, IIB and IIIA 3) age 20-70 years old 4) Performance status (ECOG performance status score)0-1 5) no prior chemotherapy with platinum-based or irinotecan regimen 6) adequate organ function . WBC>=4,000 /mm3 . Hemoglobin>=9.5g/dL . Platelet count>=100,000/mm3 . Total serum bilirubin<=1.5mg/dL . GOT, GPT<100 IU/L . Serum creatinine<=1.5mg/dL . PaO2>=70mmHg 7) without UGT1A128(TA)7/7homo, UGT1A16(211G>A)+/+homo, UGT1A128(TA)6/7hetero nor UGT1A16(211G>A)-/+hetero 8) written informed consent

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
the rate of completion of chemotherapy	—

Secondary

Measure	Time frame
3-years overall survival 3-years relapse free survival Incidence of an adverse event	—

Countries

Japan

Contacts

Public ContactKaoru Kubota

National cancer center east Thoracic Oncology Division

04-7133-1111

Outcome results

None listed

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