JCOG1205/1206: A Phase III Study Comparing Irinotecan and Cisplatin with Etoposide and Cisplatin for Adjuvant Chemotherapy of Completely Resected Pulmonary High-grade Neuroendocrine Carcinoma

Phase 3

• Conditions: Pulmonary High-grade Neuroendocrine Carcinoma

• Registration Number: JPRN-jRCTs031180216
• Lead Sponsor: TSUBOI Masahiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1) Pathologically proven high-grade neuroendocrine carcinoma (small cell carcinoma including combined small cell carcinoma or large cell neuroendocrine carcinoma including combined large cell neuroendocrine carcinoma)
2) Pathological stage I-IIIA based on the TNM classification 2009
3) Pathologically proven either of R0, R1 (is), or R1 (cy+)
4) Aged 20 to 74 years old
5) ECOG performance status of 0 or 1
6) Lobectomy or more extended surgery was performed
7) ND 2a-1 or more extended lymph node dissection was performed.
8) Within 28 to 56 days after surgery
9) No distant metastases including brain metastasis
10) No prior chemotherapy or radiotherapy for any other cancers
11) Adequate organ functions
12) Without diarrhea and intestinal obstruction of grade 1 or greater based on CTCAE v4.0.
13) Written informed consent

Exclusion Criteria

1) Synchronous or metachronous (within 5 years) malignancies except carcinoma in situ or intramucosal tumor curatively treated with local therapy
2) Active infection requiring systemic therapy
3) Body temperature >= 38 degrees Celsius
4) Pregnant or lactating women or women of childbearing potential
5) Psychiatric disease
6) Serious postoperative complications
7) Patients requiring systemic steroids medication
8) Poorly controlled diabetes mellitus or routine administration of insulin
9) Poorly controlled hypertension
10) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months
11) Positive HBs antigen
12) Positive HIV antibody
13) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse-free survival

Secondary Outcome Measures

Name	Time	Method
Overall survival, Proportion of treatment completion, Adverse events, Serious adverse events, Second malignancy