Sorafenib in Treating Patients at Risk of Relapse After Undergoing Surgery to Remove Kidney Cancer

Phase 3

Completed

• Conditions: Kidney Cancer

• Registration Number: NCT00492258
• Lead Sponsor: Medical Research Council

Brief Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sorafenib after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sorafenib is more effective than a placebo in treating kidney cancer.

PURPOSE: This randomized phase III trial is studying sorafenib to see how well it works compared with a placebo in treating patients at risk of relapse after undergoing surgery to remove kidney cancer.

Detailed Description

OBJECTIVES:

* Compare disease-free survival of patients with resected primary renal cell carcinoma at high- or intermediate-risk of relapse treated with a placebo for 3 years vs a placebo for 2 years and sorafenib tosylate for 1 year vs sorafenib tosylate for 3 years.

OUTLINE: This is a randomized, placebo-controlled, double-blind, open-label, multicenter study. Patients are randomized to 1 of 3 treatment arms.

* Arm I: Patients receive oral placebo twice daily for 3 years in the absence of disease progression or unacceptable toxicity.

* Arm II: Patients receive oral sorafenib tosylate twice daily for 1 year and oral placebo twice daily for 2 years in the absence of disease progression or unacceptable toxicity.

* Arm III: Patients receive oral sorafenib tosylate twice daily for 3 years in the absence of disease progression or unacceptable toxicity.

Patients in arms I and II with progressive disease may cross over and receive treatment in arm III.

After completion of study treatment, patients are followed periodically.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-25
• Study First Submitted QC: 2007-06-25
• Study First Posted: 2007-06-27
• Status Verified: 2008-04
• Primary Completion: 2012-08
• Study Completion: 2012-12
• Last Update Submitted: 2013-08-09
• Last Update Posted: 2013-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1656

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival

Secondary Outcome Measures

Name	Time	Method
Metastasis-free survival
Disease-specific survival time
Overall survival
Cost effectiveness
Toxicity

Trial Locations

Locations (39)

Royal Bournemouth Hospital; 🇬🇧 Bournemouth, England, United Kingdom

Bristol Haematology and Oncology Centre; 🇬🇧 Bristol, England, United Kingdom

Queen's Hospital; 🇬🇧 Burton-upon-Trent, England, United Kingdom

Addenbrooke's Hospital; 🇬🇧 Cambridge, England, United Kingdom

Gloucestershire Oncology Centre at Cheltenham General Hospital; 🇬🇧 Cheltenham, England, United Kingdom

Derbyshire Royal Infirmary; 🇬🇧 Derby, England, United Kingdom

Dorset County Hospital; 🇬🇧 Dorchester, England, United Kingdom

Gloucestershire Royal Hospital; 🇬🇧 Gloucester, England, United Kingdom

Diana Princess of Wales Hospital; 🇬🇧 Grimsby, England, United Kingdom

Princess Royal Hospital at Hull and East Yorkshire NHS Trust; 🇬🇧 Hull, England, United Kingdom

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