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Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
rofecoxib
adjuvant therapy
Sponsored by
Cancer Research Campaign Clinical Trials Centre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage II colon cancer, stage III colon cancer, stage II rectal cancer, stage III rectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed colorectal carcinoma Stage II (T3-4, N0, M0) or stage III (any T, N1-2, M0) disease Completely resected primary tumor without gross or microscopic evidence of residual disease Must have received potentially curative therapy within the past 12 weeks, including any of the following: Surgery alone Surgery plus radiotherapy and/or chemotherapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST/ALT no greater than 1.5 times ULN Renal: Creatinine clearance greater than 30 mL/min Cardiovascular: No severe congestive heart failure Other: Not pregnant or nursing Fertile patients must use effective contraception No active peptic ulcer or gastrointestinal bleeding within the past year No inflammatory bowel disease No known sensitivity to rofecoxib No prior adverse reaction to non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., asthma, acute rhinitis, nasal polyps, angioneurotic edema, or urticaria) No other malignancy within the past 10 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: No concurrent long-term NSAIDs except low-dose aspirin (no more than 80 mg/day) for cardio-prophylaxis

Sites / Locations

  • Radcliffe Infirmary NHS Trust

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 8, 2002
Last Updated
August 1, 2013
Sponsor
Cancer Research Campaign Clinical Trials Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00031863
Brief Title
Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer
Official Title
Phase III, Randomized, Double Blind, Placebo Controlled Study of Rofecoxib in Colorectal Cancer Patients Following Adjuvant Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2002
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cancer Research Campaign Clinical Trials Centre

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Rofecoxib may stop the growth of cancer by stopping blood flow to the tumor and killing tumor cells that remain after surgery. It is not yet known if rofecoxib is effective in treating colorectal cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of giving rofecoxib after surgery in treating patients who have stage II or stage III colorectal cancer.
Detailed Description
OBJECTIVES: Compare the overall survival of patients with previously resected stage II or III colorectal cancer treated with rofecoxib vs placebo administered for at least 2 years vs 5 years. Compare the relapse-free survival of patients treated with these regimens. OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to participating center, site of disease (colon vs rectum), disease stage (II vs III), age, adjuvant chemotherapy (yes vs no), and type of chemotherapy regimen (1 vs 2 vs 3 vs 4 vs 5). Within 3 months of surgical resection alone or completion of adjuvant radiotherapy and/or chemotherapy after surgical resection, patients are randomized to one of four treatment arms. Arm I: Patients receive oral rofecoxib once daily for 2 years. Arm II: Patients receive oral rofecoxib once daily for 5 years. Arm III: Patients receive oral placebo once daily for 2 years. Arm IV: Patients receive oral placebo once daily for 5 years. Treatment continues in all arms in the absence of disease recurrence or unacceptable toxicity. PROJECTED ACCRUAL: A total of 7,000 patients (1,750 per treatment arm) will be accrued for this study within 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage II colon cancer, stage III colon cancer, stage II rectal cancer, stage III rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rofecoxib
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed colorectal carcinoma Stage II (T3-4, N0, M0) or stage III (any T, N1-2, M0) disease Completely resected primary tumor without gross or microscopic evidence of residual disease Must have received potentially curative therapy within the past 12 weeks, including any of the following: Surgery alone Surgery plus radiotherapy and/or chemotherapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST/ALT no greater than 1.5 times ULN Renal: Creatinine clearance greater than 30 mL/min Cardiovascular: No severe congestive heart failure Other: Not pregnant or nursing Fertile patients must use effective contraception No active peptic ulcer or gastrointestinal bleeding within the past year No inflammatory bowel disease No known sensitivity to rofecoxib No prior adverse reaction to non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., asthma, acute rhinitis, nasal polyps, angioneurotic edema, or urticaria) No other malignancy within the past 10 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: No concurrent long-term NSAIDs except low-dose aspirin (no more than 80 mg/day) for cardio-prophylaxis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J. Kerr, MD, FRCP, DSc
Organizational Affiliation
Oxford University Hospitals NHS Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Radcliffe Infirmary NHS Trust
City
Oxford
State/Province
England
ZIP/Postal Code
OX2 6HE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20837956
Citation
Midgley RS, McConkey CC, Johnstone EC, Dunn JA, Smith JL, Grumett SA, Julier P, Iveson C, Yanagisawa Y, Warren B, Langman MJ, Kerr DJ. Phase III randomized trial assessing rofecoxib in the adjuvant setting of colorectal cancer: final results of the VICTOR trial. J Clin Oncol. 2010 Oct 20;28(30):4575-80. doi: 10.1200/JCO.2010.29.6244. Epub 2010 Sep 13.
Results Reference
result
PubMed Identifier
17652651
Citation
Kerr DJ, Dunn JA, Langman MJ, Smith JL, Midgley RS, Stanley A, Stokes JC, Julier P, Iveson C, Duvvuri R, McConkey CC; VICTOR Trial Group. Rofecoxib and cardiovascular adverse events in adjuvant treatment of colorectal cancer. N Engl J Med. 2007 Jul 26;357(4):360-9. doi: 10.1056/NEJMoa071841.
Results Reference
result

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Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer

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