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) studied | pulmonary neoplasm |
| Date of first enrollment | 2002/10/01 |
| Target sample size | 80 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Preoperative docetaxel-cisplatin combination chemotherapy Preoperative docetaxel monotherapy |
Outcome(s)
| Primary Outcome | Disease-free survival rate at 1 year |
|---|---|
| Secondary Outcome | overall 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 minimum | 20years-old |
|---|---|
| Age maximum | 74years-old |
| Gender | Male 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
| Primary Sponsor | Japan Clinical Oncology Group(JCOG) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) | NCT00132639 |
Contact
| public contact | |
| Name | Hideo Kunitoh, M.D. |
| Address | 1 Kandaizumi-cho, Chiyoda-ku, Tokyo 101-8643, Japan Japan |
| Telephone | |
| JCOG_sir@ml.jcog.jp | |
| 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 |
| Telephone | |
| Affiliation | International University of Health and Welfare Research Institute of Health and Welfare Sciences, Graduate School |