Back to resultsA Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
UFT (uracil, tegafur)
Surgery alone
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal Cancer
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Prior anticancer treatment
Sites / Locations
- National Cancer Center Hospital East
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
1
2
Arm Description
UFT (uracil, tegafur)
Surgery alone
Outcomes
Primary Outcome Measures
Relapse-free survival and overall survival
Secondary Outcome Measures
Adverse events
Full Information
NCT ID
NCT00152230
First Posted
September 8, 2005
Last Updated
July 6, 2011
Sponsor
Taiho Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00152230
Brief Title
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC)
Official Title
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of UFT Compared With Surgery Alone in Patients With Dukes C Colorectal Cancer (NSAS-CC)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
October 1996 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Taiho Pharmaceutical Co., Ltd.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
900 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
UFT (uracil, tegafur)
Arm Title
2
Arm Type
Other
Arm Description
Surgery alone
Intervention Type
Drug
Intervention Name(s)
UFT (uracil, tegafur)
Intervention Description
to receive oral uracil-tegafur 400 mg square meter for one year
Intervention Type
Procedure
Intervention Name(s)
Surgery alone
Intervention Description
Standardized mesorectal excision with selective lateral pelvic lymphadenectomy of stage III rectal cancer.
Primary Outcome Measure Information:
Title
Relapse-free survival and overall survival
Time Frame
every course for first three courses, then every other course
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
any time
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Prior anticancer treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shigeaki Yoshida, MD
Organizational Affiliation
National Cancer Center Hospital East
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center Hospital East
City
6-5-1, Kashiwanoha, Kashiwa, Chiba
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
20490797
Citation
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 Reference
background
PubMed Identifier
16675478
Citation
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.
Results Reference
result
Learn more about this trial
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC)
We'll reach out to this number within 24 hrs