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Phase III Randomized Study of Sorafenib Tosylate in Patients With Resected Primary Renal Cell Carcinoma at High- or Intermediate-Risk of Relapse
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
Sorafenib in Treating Patients at Risk of Relapse After Undergoing Surgery to Remove Kidney Cancer
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
---|
Phase III | Treatment | Active | Over 18 | MRC-RE05-SORCE MRC-RE05-SORCE, EUDRACT ID 2006-006079-19, EU-20734, NCT00492258, SORCE, ISRCTN38934710 |
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.
Entry Criteria Disease Characteristics:
- Histologically confirmed renal cell carcinoma (RCC)
- Clear cell or non-clear cell tumors allowed
- Intermediate- or high-risk disease (Leibovich score 3 to 11)
- Must have undergone surgery for RCC at least 4 weeks but no more than 3 months
prior to study entry
- No evidence of residual macroscopic disease on post-operative CT scan after
resection of RCC
Prior/Concurrent Therapy:
- See Disease Characteristics
- No prior treatment for RCC other than nephrectomy
- More than 30 days since prior and no other concurrent investigational therapy
- No concurrent medications that have adverse interactions with sorafenib tosylate including, but not limited to, any of the following:
- Rifampin
- Grapefruit juice
- Ritonavir
- Ketoconazole
- Itraconazole
- Hypericum perforatum (St John’s
wort)
- No concurrent bone marrow transplant or stem cell rescue
- No other concurrent drug that targets angiogenesis, especially VEGF or VEGF receptors (e.g., bevacizumab)
- No other concurrent drug that targets Ras-pathway or EGFR
- No other concurrent anticancer therapy (chemotherapy, immunotherapy, signal transduction inhibition, or hormonal therapy)
- Concurrent non-conventional therapies (e.g., herbs or acupuncture) and vitamin or mineral supplements allowed
- Concurrent bisphosphonates for prophylaxis of osteoporosis allowed
Patient Characteristics:
- WHO performance status 0-1
- WBC > 3,400/mm³
- Platelet count > 99,000/mm³
- Creatinine < 2.5 times upper limit of normal (ULN)
- Liver function tests <
1.5 times ULN
- Serum amylase < 1.5 times ULN
- PT/INR < 1.5 times ULN
- PTT < 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 9 months after completion of study treatment
- No cardiovascular conditions, including any of the following:
- Cardiac arrhythmias requiring anti-arrhythmic medication
- Beta-blockers and digoxin
allowed
- Symptomatic coronary artery disease or ischemia
- Myocardial
infarction within the past 6 months
- NYHA class II-IV
congestive heart failure
- No active clinically serious bacterial or fungal infection
- No known history of HIV infection
- No chronic
hepatitis B or C
- No other prior malignancy except carcinoma in situ of the cervix or adequately treated
basal cell carcinoma
- No uncontrolled hypertension
Expected Enrollment 1656Outcomes Primary Outcome(s)Disease-free survival
Secondary Outcome(s)Metastasis-free survival Disease-specific survival time Overall survival Cost effectiveness Toxicity
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.
Trial Contact Information
Trial Lead Organizations Medical Research Council Clinical Trials Unit ![](https://webarchive.library.unt.edu/eot2008/20090515034504im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20090515034504im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20090515034504im_/http://www.cancer.gov/images/spacer.gif) | Timothy Eisen, Principal investigator | ![](https://webarchive.library.unt.edu/eot2008/20090515034504im_/http://www.cancer.gov/images/spacer.gif) | | ![](https://webarchive.library.unt.edu/eot2008/20090515034504im_/http://www.cancer.gov/images/spacer.gif) | Trial Sites
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United Kingdom |
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England |
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Bournemouth |
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| | | | Royal Bournemouth Hospital NHS Trust |
| | Tamas Hickish, MD | |
| Email:
tamas.hickish@rbch.nhs.uk |
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Bristol |
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| | Bristol Haematology and Oncology Centre |
| | Contact Person | |
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Burton-upon-Trent |
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| | Queen's Hospital |
| | Contact Person | Ph: | 44-128-356-6333 ext. 5465 | | |
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Cambridge |
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| | Addenbrooke's Hospital |
| | Timothy Eisen | |
| Email:
tgqe2@cam.ac.uk |
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Cheltenham |
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| | Cheltenham General Hospital |
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Derby |
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| | Derbyshire Royal Infirmary |
| | Prabir Chakraborti, MD | |
| Email:
prchakraborh@hotmail.com |
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Dorchester |
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| | Dorset County Hospital |
| | Contact Person | |
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Gloucester |
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| | Gloucestershire Royal Hospital |
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Grimsby |
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| | Diana Princess of Wales Hospital |
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Hull |
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| | Princess Royal Hospital at Hull and East Yorkshire NHS Trust |
| | Contact Person | |
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Ipswich |
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| | Ipswich Hospital |
| | Christopher Scrase, MD | |
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Leeds |
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| | Leeds Cancer Centre at St. James's University Hospital |
| | Contact Person | |
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Leicester |
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| | Leicester Royal Infirmary |
| | Contact Person | |
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Lincoln |
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| | Lincoln County Hospital |
| | Contact Person | |
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London |
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| | Charing Cross Hospital |
| | Contact Person | |
| | Guy's Hospital |
| | Contact Person | |
| | Medical Research Council Clinical Trials Unit |
| | Contact Person | |
| | Royal Marsden - London |
| | Martin Gore, MD | |
| Email:
martin.gore@rmh.nhs.uk |
| | Saint Bartholomew's Hospital |
| | Contact Person | |
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Maidstone |
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| | Maidstone Hospital |
| | Contact Person | |
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Manchester |
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| | Christie Hospital |
| | Contact Person | |
| | Robert Hawkins, MD | |
| Email:
rhawkins@picr.man.ac.uk |
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Merseyside |
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| | Clatterbridge Centre for Oncology |
| | Ernest Marshall, MD | |
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Middlesbrough |
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| | James Cook University Hospital |
| | Contact Person | |
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Newcastle-Upon-Tyne |
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| | Northern Centre for Cancer Treatment at Newcastle General Hospital |
| | Contact Person | |
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Northwood |
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| | Mount Vernon Cancer Centre at Mount Vernon Hospital |
| | Contact Person | |
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Plymouth |
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| | Derriford Hospital |
| | Contact Person | |
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Poole Dorset |
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| | Poole Hospital NHS Trust |
| | Contact Person | |
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Portsmouth Hants |
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| | Portsmouth Oncology Centre at Saint Mary's Hospital |
| | Contact Person | Ph: | 44-239-228-6000 ext. 3896 | | |
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Prescot Merseyside |
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| | Whiston Hospital |
| | Contact Person | Ph: | 44-151-334-1155 ext. 4814 | | |
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Reading |
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| | Berkshire Cancer Centre at Royal Berkshire Hospital |
| | Contact Person | |
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Scarborough |
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| | Scarborough General Hospital |
| | Simon Hawkyard, MD | |
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Scunthorpe |
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| | Scunthorpe General Hospital |
| | Contact Person | Ph: | 44-17-2428-2282 ext. 2263 | | |
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Sheffield |
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| | Cancer Research Centre at Weston Park Hospital |
| | Contact Person | Ph: | 44-114-226-5000 ext. 5007 | | |
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Slough, Berkshire |
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| | Wexham Park Hospital |
| | Contact Person | |
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Southampton |
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| | Southampton General Hospital |
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Stoke-On-Trent |
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| | University Hospital of North Staffordshire |
| | Contact Person | |
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Torquay |
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| | Torbay Hospital |
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Scotland |
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Aberdeen |
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| | | Aberdeen Royal Infirmary |
| | Contact Person | |
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Wales |
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Cardiff |
![](https://webarchive.library.unt.edu/eot2008/20090515034504im_/http://www.cancer.gov/images/spacer.gif) |
| | | Velindre Cancer Center at Velindre Hospital |
| | Contact Person | |
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Registry Information | ![](https://webarchive.library.unt.edu/eot2008/20090515034504im_/http://www.cancer.gov/images/spacer.gif) | Official Title | | SORCE: A Phase III Randomised Double-Blind Study Comparing Sorafenib with Placebo in Patients with Resected Primary Renal Cell Carcinoma at High or Intermediate Risk of Relapse | ![](https://webarchive.library.unt.edu/eot2008/20090515034504im_/http://www.cancer.gov/images/spacer.gif) | Trial Start Date | | 2007-06-01 | ![](https://webarchive.library.unt.edu/eot2008/20090515034504im_/http://www.cancer.gov/images/spacer.gif) | Trial Completion Date | | 2012-08-01 (estimated) | ![](https://webarchive.library.unt.edu/eot2008/20090515034504im_/http://www.cancer.gov/images/spacer.gif) | Registered in ClinicalTrials.gov | | NCT00492258 | ![](https://webarchive.library.unt.edu/eot2008/20090515034504im_/http://www.cancer.gov/images/spacer.gif) | Date Submitted to PDQ | | 2007-05-30 | ![](https://webarchive.library.unt.edu/eot2008/20090515034504im_/http://www.cancer.gov/images/spacer.gif) | Information Last Verified | | 2008-04-29 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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