NIPH Clinical Trials Search

UMIN ID: C000000109

Registered date:02/09/2005

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedLD-SCLC
Date of first enrollment2001/01/01
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Cisplatin and etoposide with concurrent twice-daily thoracic irradiation followed by 3 cycles of cisplatin and irinotecan


Primary OutcomeTwo-year survival rate
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum70years-old
GenderMale and Female
Include criteria
Exclude criteria1. 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

Related Information


public contact
Name Shinichiro Nakamura
Address Japan
Telephone 06-6633-7400
Affiliation West Japan Oncology Group WJOG datacenter
scientific contact
Name Hiroshi Saito, M.D.
Address 18 Kuriyado Kake-machi, Okazaki Aichi 444-0011, Japan. Japan
Affiliation Aichi Cancer Center Aichi Hospital Department of Respiratory Medicine