UMIN ID: C000000096
Registered date:30/08/2005
Neoadjuvant and adjuvant chemotherapy with ifosfamide and adriamycin for adult high-grade soft tissue sarcomas in the extremities (JCOG0304, Neoadjuvant and adjuvant chemotherapy with IFO/ADM phase II)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | soft tissue sarcoma |
| Date of first enrollment | 2004/03/01 |
| Target sample size | 75 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Neoadjuvant and adjuvant chemotherapy |
Outcome(s)
| Primary Outcome | response rate |
|---|---|
| Secondary Outcome | 2-year progression free survival, time to progression, overall survival, adverse effect, post-operative morbidity |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 65years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Poorly controlled diabetes mellitus 2) poorly controlled hypertension 3) history of myocardial infarction or angina 4) cardiac pacemaker 5) severe urinary dysfunction 6) infectious disease which requires treatment 7) mental disease or mental symptoms which would affect the patient's decision to participate 8) women in pregnant, possibly pregnant or breast feeding 9) active double cancer 10) continuous systemic medication of steroids |
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) |
Contact
| public contact | |
| Name | Kazuhiro Tanaka, MD, PhD |
| Address | 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, JAPAN Japan |
| Telephone | |
| JCOG_sir@ml.jcog.jp | |
| Affiliation | JCOG0304 Coordinating Office Department of Orthopaedic Surgery, Kyushu University Hospital |
| scientific contact | |
| Name | Yukihide Iwamoto, MD, PhD |
| Address | 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, JAPAN Japan |
| Telephone | |
| Affiliation | Graduate School of Medical Sciences, Kyushu University Department of Orthopaedic Surgery |