UMIN ID: UMIN000001791
Registered date:01/05/2009
Multicenter Phase II Study of Combination Epitope Peptides with mFOLFOX6 in Advanced/metastatic Colorectal Cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Metastatic chemo naive colorectal cancer |
| Date of first enrollment | 2009/01/01 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | HLA-A2402 positive HLA-A2402 negative |
Outcome(s)
| Primary Outcome | the efficacy (response rate, time to progression) |
|---|---|
| Secondary Outcome | 1. Safety 2. Over all survival 3. Induction of immune responses 4. Progression free survival |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Severe heart diseases 2. Wish for pregnancy 3. Active infection 4. Steroid or immunosuppressive therapy 5. Allergy for using epitope peptides 6. Mental and nervous disorder 7. Massive pleural or abdominal effusions 8. Peripheral nervous disorder 9. Diarrhea 10. Doctors opinion |
Related Information
| Primary Sponsor | YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE Department of Digestive Surgery and Surgical Oncology |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Yamaguchi University Tokyo University |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shoichi Hazama |
| Address | 1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan Japan |
| Telephone | 0836-22-2264 |
| hazama-jsgs@umin.ac.jp | |
| Affiliation | YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE Department of Digestive Surgery and Surgical Oncology |
| scientific contact | |
| Name | Masaaki Oka |
| Address | 1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan Japan |
| Telephone | 0836-22-2264 |
| hazama@yamaguchi-u.ac.jp | |
| Affiliation | YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE Department of Digestive Surgery and Surgical Oncology |