A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC)
Summary
This is a controlled study designed to compare relapse-free survival and overall survival in patients receiving UFT with those in patients receiving surgery alone. Patients will be randomly assigned to surgery alone or surgery followed by UFT within 6 weeks after curative resection. To assess treatment efficacy, data on recurrence and survival will be collected for 5 years after enrollment of the last patient. To evaluate safety, data on adverse events will be collected for 12 months after the start of treatment.Evaluations will be separately done for colon cancer and rectal cancer.
Timeline
- Start
- 1996-10
- Primary completion
- 2006-03
- Completion
- 2008-02
Outcome
Met primary endpoint
paper Planned interim analysis 2 years after accrual termination revealed significant prolongation of relapse-free survival (P = 0.001) PMID 16675478 ↗
paper The 3-year relapse-free survival and overall survival rates were 78 and 91% in the chemotherapy group and 60 and 81% in the surgery-alone group, respectively. PMID 16675478 ↗
Publications
- Background Hamaguchi T, Shirao K, Moriya Y, Yoshida S, Kodaira S, Ohashi Y; NSAS-CC Group. Final results of randomized trials by the National Surgical Adjuvant Study of Colorectal Cancer (NSAS-CC). Cancer Chemother Pharmacol. 2011 Mar;67(3):587-96. doi: 10.1007/s00280-010-1358-1. Epub 2010 May 19.
- Results Akasu T, Moriya Y, Ohashi Y, Yoshida S, Shirao K, Kodaira S; National Surgical Adjuvant Study of Colorectal Cancer. Adjuvant chemotherapy with uracil-tegafur for pathological stage III rectal cancer after mesorectal excision with selective lateral pelvic lymphadenectomy: a multicenter randomized controlled trial. Jpn J Clin Oncol. 2006 Apr;36(4):237-44. doi: 10.1093/jjco/hyl014. Epub 2006 May 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | UFT | Unknown | 400 mg/m2 | Oral |