Small-Cell-Lung Cancer
Conditions
Keywords
Small-cell lung cancer, Limited-Stage Small-Cell Lung Cancer, Combined modality therapy, chemotherapy, radiotherapy, Irinotecan, Cisplatin
Brief summary
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.
Detailed 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.
Interventions
DRUGEtoposide and cisplatin after chemoradiotherapy
Etoposide and cisplatin after chemoradiotherapy
DRUGIrinotecan and cisplatin after chemoradiotherapy
Irinotecan and cisplatin after chemoradiotherapy
Sponsors
Ministry of Health, Labour and Welfare, Japan
Haruhiko Fukuda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | during the study conduct |
Secondary
| Measure | Time frame |
|---|---|
| adverse events of induction chemoradiotherapy | during the study conduct |
| chemotherapy after chemoradiotherapy | during the study conduct |
| late radiation morbidity | during the study conduct |
| serious adverse event | during the study conduct |
| progression-free survival | during the study conduct |
Countries
Japan
Outcome results
None listed