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

JRCT ID: jRCTs031180216

Registered date:08/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Pulmonary High-grade Neuroendocrine Carcinoma
• Date of first enrollment: 18/04/2013
• Target sample size: 220
• Study type: Interventional

Intervention(s)

Arm A: Etoposide + Cisplatin (every 3 weeks) X 4 courses
[Etoposide] 100 mg/m2, day 1,2,3
[Cisplatin] 80 mg/m2, day 1

B: Irinotecan + Cisplatin (every 4 weeks) X 4 courses
[Irinotecan] 60 mg/m2, day 1,8,15
[Cisplatin] 60 mg/m2, day 1

Outcome(s)

• Primary Outcome: Relapse-free survival
• Secondary Outcome: Overall survival, Proportion of treatment completion, Adverse events, Serious adverse events, Second malignancy

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 74age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: TSUBOI Masahiro
• Secondary Sponsor: NIHO Seiji
• Source(s) of Monetary Support: National Cancer Center Japan,Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000010298