UMIN ID: C000000031
Registered date:28/07/2005
A phase II trial of pre-operative chemoradiotherapy followed by surgical resection in Pancoast tumors: initial report of Japan Clinical Oncology Group trial (JCOG 9806)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | pulmonary neoplasm |
| Date of first enrollment | 1999/05/01 |
| Target sample size | 75 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Preoperative mytomicin C-vindesine-cisplatin combination chemotherapy and thoracic radiotherapy |
Outcome(s)
| Primary Outcome | 3-year survival rate |
|---|---|
| Secondary Outcome | complete resection rate, post-surgical morbidity/mortality, local control rate |
Key inclusion & exclusion criteria
| Age minimum | 15years-old |
|---|---|
| Age maximum | 74years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Metastasis to, or involvement of, mediastinal node (N2) Distant metastasis or dissemination to pleura/pericardium Active concomitant malignancy Unstable angina, recent myocardial infarction, heart failure Uncontrolled diabetes or hypertension Pregnant or lactating women Other severe complications |
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) | NCT00128037 |
Contact
| public contact | |
| Name | Hideo Kunitoh, M.D. |
| Address | 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, JAPAN Japan |
| Telephone | |
| JCOG_sir@ml.jcog.jp | |
| Affiliation | JCOG9806 Coordinating Office Medical Oncology Division, National Cancer Center Hospital |
| scientific contact | |
| Name | Harubumi Kato, M.D., Ph.D. |
| Address | 6-7-1 Nishishinnjuku, Shinjuku-ku, Tokyo, 160-0023, JAPAN Japan |
| Telephone | |
| Affiliation | Tokyo Medical University First Department of Surgery |