UMIN ID: C000000223
Registered date:13/09/2005
A randomized controlled trial of chemotherapy with 5FU and cisplatin before and after surgery for stage II,III squamous cell carcinoma of the thoracic esophagus (JCOG9907)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | esophageal squamous cell carcinoma |
| Date of first enrollment | 2000/05/01 |
| Target sample size | 330 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Surgery +(Cisplatin 80 mg/m2 +5FU 800mg/m2 x5days) x2 (Cisplatin 80 mg/m2 +5FU 800mg/m2 x5days) x2 +Surgery |
Outcome(s)
| Primary Outcome | Disease free survival |
|---|---|
| Secondary Outcome | Overall survival, Toxicity of chemotherapy, Operaive morbidity |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | (1)severe heart diseases (2)uncontrolable hyper tension or diabetes mellitus (3)severe pulmonary dysfunction (4)HBs positive (5)active bacterial infection (6)synchronous or metachronous (within 5 years) malignancy (7)pregnant female (8)psychiatric medication |
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) | NCT00190554 |
Contact
| public contact | |
| Name | Nobutoshi Ando, M.D. |
| Address | 5-11-13, Sugano, Ichikawashi, Chiba 272-8513 Japan Japan |
| Telephone | |
| JCOG_sir@ml.jcog.jp | |
| Affiliation | JCOG9907 Coordinating Office Department of Surgery, Tokyo Dental College Ichikawa General Hospital |
| scientific contact | |
| Name | Nobutoshi Ando, M.D. |
| Address | 5-11-13, Sugano, Ichikawashi, Chiba 272-8513 Japan Japan |
| Telephone | |
| Affiliation | Tokyo Dental College Ichikawa General Hospital Department of Surgery |