UMIN ID: UMIN000000996
Registered date:25/01/2008
A phase II study of oxaliplatin, folinic acid and 5-fluorouracil (modified FOLFOX-6) combination chemotherapy as adjuvant treatment after resection of liver metastases from colorectal cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | liver metastases of colorectal cancer |
| Date of first enrollment | 2006/07/01 |
| Target sample size | 50 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | To undergo modified folfox 6 regimen [5-fluorouracil 2.4 g/m2 (24-h continuous infusion), l-leucovorin 200 mg/m2 (2-h intravenous infusion), and oxaliplatin 85 mg/m2 (2-h intravenous infusion) every 2 weeks] for 24 weeks as adjuvant treatment after resection of liver metastases from colorectal cancer. |
Outcome(s)
| Primary Outcome | disease free survival side effect |
|---|---|
| Secondary Outcome | overall survival |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | (1) Multiple cancer (2) Prebious history of severe drug-induced allergy (3) Given L-OHP within 6 months before this study (4) Active infection (5) Severe complication (6) Severe sensory disturbance (7) Pregnant (8) Disqualified by attendig doctor |
Related Information
| Primary Sponsor | Miyagi HBPCOG |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Division of Hepato-Biliary Pancreatic Surgery. Tohoku University Graduate School of Medicine. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kuniharu Yamamoto |
| Address | 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN Japan |
| Telephone | 022-717-7208 |
| kyama@surg1.med.tohoku.ac.jp | |
| Affiliation | Miyagi HBPCOG coordinating office Division of Hepato-Biliary Pancreatic Surgery. Tohoku University Graduate School of Medicine. |
| scientific contact | |
| Name | Michiaki Unno |
| Address | 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN Japan |
| Telephone | 022-717-7208 |
| kein_h11@surg1.med.tohoku.ac.jp | |
| Affiliation | Tohoku University Graduate School of Medicine Division of Hepato-Biliary Pancreatic Surgery |