A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC)

NCT00152230 | Completed Phase 3

• 1 other identifier: 01023002
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Relapse-free survival and overall survival

  every course for first three courses, then every other course

Secondary Outcomes (1)

• Adverse events

  any time

Study Arms (2)

1

EXPERIMENTAL

UFT (uracil, tegafur)

Drug: UFT (uracil, tegafur)

2

OTHER

Surgery alone

Procedure: Surgery alone

Interventions

UFT (uracil, tegafur) DRUG

to receive oral uracil-tegafur 400 mg square meter for one year

1

Surgery alone PROCEDURE

Standardized mesorectal excision with selective lateral pelvic lymphadenectomy of stage III rectal cancer.

2

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20 to 75
• Performance status 0 , 1, or 2 (ECOG)
• Hematopoietic WBC ≥ 4,000/mm\^3 Platelet ≥ 100,000/mm\^3
• Hepatic AST and ALT ≤ 2 times upper limit of normal(ULN) Total bilirubin ≤ 1.2mg/dL
• Renal BUN ≤ 25mg/dL Creatinine ≤ 1.5mg/dL

You may not qualify if:

• Prior anticancer treatment

Sponsors & Collaborators

• Taiho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

National Cancer Center Hospital East

6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan

Location

Related Publications (2)

• 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.

  PMID: 20490797 BACKGROUND

• 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.

  PMID: 16675478 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Tegafur; Uracil; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Fluorouracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Shigeaki Yoshida, MD

  National Cancer Center Hospital East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 9, 2005
• Study Start: October 1, 1996
• Primary Completion: March 1, 2006
• Study Completion: February 1, 2008
• Last Updated: July 7, 2011

Record last verified: 2011-07

Locations

JP (1)