UMIN ID: C000000114
Registered date:05/09/2005
The safety and efficacy trial of primary chemo-radiotherapy for stage I to IIIA breast cancer (JCOG0306)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | stage I to IIIA breast cancer |
| Date of first enrollment | 2004/07/01 |
| Target sample size | 104 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Doxorubicine+cyclophosphamide followed by paclitaxel, radiotherapy |
Outcome(s)
| Primary Outcome | pathological complete response rate |
|---|---|
| Secondary Outcome | toxicity, clinical complete response rate, breast conserving rate, relapse free survival, overall survival |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 70years-old |
| Gender | Female |
| Include criteria | |
| Exclude criteria | 1) Current history of malignant neoplasms except for curative carcinoma in situ or mucosal carsinoma 2) Pregnant or lactating women or women of childbearing potential 3) Active infectious diesase 4) Past histry of allergic reaction to cremophor EL(polyoxethylated castor oil) or polysorbate 5) Interstitial pneumonia or fibroid lung reveald by chest x-ray 6) Poorly controlled or insulin dependent diabetes mellitus 7) Psychological disease or psychological symptom that interferes with entering this trial |
Related Information
| Primary Sponsor | Japan Clinical Oncology Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hirofumi Mukai, MD |
| Address | 6-5-1 kashiwahoha, Kashiwa-shi, Chiba, 277-8577, Japan Japan |
| Telephone | |
| JCOG_sir@ml.jcog.jp | |
| Affiliation | JCOG0306 Coordinating Office Divison of Oncology and Hematology, National Cancer Center Hospital East |
| scientific contact | |
| Name | Toru Watanabe, MD , PhD |
| Address | 117 Shinmachi Hamamatsu, Shizuoka 430-0921, Japan Japan |
| Telephone | |
| Affiliation | Hamamatsu Oncology Center Medical Oncology |