A Phase II Study of Cisplatin, Etoposide and Concurrent Thoracic Irradiation Followed by Irinotecan and Cisplatin in Patients with Limited Small-Cell Lung Cancer

A Phase II Study of Cisplatin, Etoposide and Concurrent Thoracic Irradiation Followed by Irinotecan and Cisplatin in Patients with Limited Small-Cell Lung Cancer - A Phase II Study of Cisplatin, Etoposide and Concurrent Thoracic Irradiation Followed by Irinotecan and Cisplatin in Patients with Limited Small-Cell Lung Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000109

Enrollment

Registered

2005-09-02

Start date

2001-01-01

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

LD-SCLC

Interventions

Cisplatin and etoposide with concurrent twice-daily thoracic irradiation followed by 3 cycles of cisplatin and irinotecan

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed limited-stage SCLC 2. No prior chemotherapy or radiotherapy 3. Measurable disease 4. ECOG performance status of 0-2 5. Age between 20 and 70 years 6. Life expectancy ≥ 3 months 7. Adequate organ funtion: Leukocyte count from 4,000 to 12,000/mm3; hemoglobin concentration ≥9.5 g/dl; platelet count ≥100,000/mm3; aspartate aminotransferase and alanine aminotransferase ≤2 times of the upper limit of normal value; serum bilirubin ≤1.5 mg/d; serum creatinine ≤the upper limit of normal value; 24-hour creatinine clearance ≥60 ml/min; and PaO2 ≥70 torr 8. Signed informed consent

Exclusion criteria

Exclusion criteria: 1. Clinically apparent interstitial pneumonitis or pulmonary fibrosis 2. Emphysema, chronic bronchitis or bronchial asthma which precludes thoracic radiotherapy 3. Malignant pleural effusion or malignant pericardial effusion 4. Active concomitant or a recent (<3 years) history of any malignancy 5. Uncontrolled hypertension, unstable angina pectoris, myocardial infarction <3 months before enrollment or congestive heart failure 6. Uncontrolled diabetes mellitus 7. Uncontrolled severe active infection 8. Intestinal paralysis or obstruction 9. Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Two-year survival rate	—

Countries

Japan

Contacts

Public ContactShinichiro Nakamura

West Japan Oncology Group WJOG datacenter

06-6633-7400

Outcome results

None listed

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