NIPH Clinical Trials Search

UMIN ID: C000000032

Registered date:28/07/2005

Randomized phase II study of the Induction Chemotherapy with Docetaxel alone vs CDDP+Docetaxel for c-stage IB-II Non-Small Cell Lung Cancer (JCOG 0204-MF)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedpulmonary neoplasm
Date of first enrollment2002/10/01
Target sample size80
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Preoperative docetaxel-cisplatin combination chemotherapy Preoperative docetaxel monotherapy


Primary OutcomeDisease-free survival rate at 1 year
Secondary Outcomeoverall survical, disease-free survival, treatment compliance, response rate to chemotherapy, pathologic CR rate, complete resection rate, post-surgical morbidity/mortality

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum74years-old
GenderMale and Female
Include criteria
Exclude criteria(1) Invasion to the first rib or more superior chest wall (2) Metastasis to, or involvement of, mediastinal node (3) Active concomitant malignancy (4)Unstable angina, recent myocardial infarction, heart failure (5)Uncontrolled diabetes or hypertension (6) Pregnant or lactating women (7)Other severe complications (8)Systemic use of corticosteroid

Related Information


public contact
Name Hideo Kunitoh, M.D.
Address 1 Kandaizumi-cho, Chiyoda-ku, Tokyo 101-8643, Japan Japan
Affiliation JCOG0204 Coordinating Office Department of Respiratory Medicine, Mitsui Memorial Hospital
scientific contact
Name Harubumi Kato, M.D., Ph.D.
Address 1-3-3 Minamiaoyama, Minato-ku, Tokyo, 107-0062, JAPAN Japan
Affiliation International University of Health and Welfare Research Institute of Health and Welfare Sciences, Graduate School