A Study Comparing Irinotecan and Cisplatin (IP) With Etoposide and Cisplatin (EP) Following EP/TRT for LD-SCLC

Haruhiko Fukuda

Status and phase: Completed; Phase 3

Conditions: Small-Cell-Lung Cancer

Treatments: Drug: Irinotecan and cisplatin after chemoradiotherapy; Drug: Etoposide and cisplatin after chemoradiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00144989

JCOG0202-MF

C000000095

Details and patient eligibility

About

To evaluate the role of 3 cycles of irinotecan and cisplatin for patients with limited-stage small-cell lung cancer who received one course of etoposide and cisplatin plus concurrent accelerated hyperfractionated thoracic irradiation.

Full description

The Japan Clinical Oncology Group (JCOG) previously conducted a randomized phase III trial comparing irinotecan and cisplatin (IP) with EP in patients with extensive-stage SCLC. The response rate and overall median survival were significantly better for IP, i.e. 84.4% and 12.8 months with IP, versus 67.5% and 9.4 months with EP, respectively. The 2-year survival rates were 19.5% for IP and 5.2% for EP (7). These encouraging results prompted us to explore the use of IP in LSCLC.

Enrollment: 281 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. cytologically, histologically proven small-cell lung cancer
2. limited disease
3. age 20-70 years old
4. performance status of 0-1
5. measurable disease
6. no prior treatment for small-cell lung cancer
7. no history of chemotherapy
8. adequate organ functions
9. written informed consent

Exclusion criteria

1. pericardial effusion
2. active concomitant malignancy
3. pregnant or lactating women
4. interstitial pneumonia/active lung fibrosis on chest x-ray, watery diarrhea, intestinal obstruction or paralysis, uncontrolled heart disease or a history of myocardial infarction within the previous 6 months, uncontrolled diabetes mellitus, active infection, psychological disease deemed unacceptable for inclusion to the study, long-term steroid treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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281 participants in 2 patient groups

1

Active Comparator group

Description:

Etoposide and cisplatin after chemoradiotherapy

Treatment:

Drug: Etoposide and cisplatin after chemoradiotherapy

2

Experimental group

Description:

Irinotecan and cisplatin after chemoradiotherapy

Treatment:

Drug: Irinotecan and cisplatin after chemoradiotherapy