AzTrials
AzTrials

Kidney CancerPhase 3NCT00492258

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

A Phase 3 study testing sorafenib tosylate and adjuvant therapy in people with Kidney Cancer, run by Medical Research Council at 39 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Cancer
What is being tested?
sorafenib tosylate and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
1,656 participants
Where
39 sitesUnited Kingdom
Study dates
Jun 2007to Dec 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

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

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

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

United Kingdom39 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland, AB25 2ZN

  • Royal Bournemouth Hospital

    Bournemouth, England, BH7 7DW

  • Bristol Haematology and Oncology Centre

    Bristol, England, BS2 8ED

  • Queen's Hospital

    Burton-on-Trent, England, DE13 0RB

  • Addenbrooke's Hospital

    Cambridge, England, CB2 2QQ

  • Velindre Cancer Center at Velindre Hospital

    Cardiff, Wales, CF14 2TL

  • Gloucestershire Oncology Centre at Cheltenham General Hospital

    Cheltenham, England, GL53 7AN

  • Derbyshire Royal Infirmary

    Derby, England, DE1 2QY

  • Dorset County Hospital

    Dorchester, England, DT1 2JY

  • Gloucestershire Royal Hospital

    Gloucester, England, GL1 3NN

  • Diana Princess of Wales Hospital

    Grimsby, England, DN33 2BA

  • Princess Royal Hospital at Hull and East Yorkshire NHS Trust

    Hull, England, HU8 9HE

  • Ipswich Hospital

    Ipswich, England, IP4 5PD

  • Leeds Cancer Centre at St. James's University Hospital

    Leeds, England, LS9 7TF

  • Leicester Royal Infirmary

    Leicester, England, LE1 5WW

  • Lincoln County Hospital

    Lincoln, England, LN2 5QY

  • Saint Bartholomew's Hospital

    London, England, EC1A 7BE

  • Medical Research Council Clinical Trials Unit

    London, England, NW1 2DA

  • Guy's Hospital

    London, England, SE1 9RT

  • Royal Marsden - London

    London, England, SW3 6JJ

  • Charing Cross Hospital

    London, England, W6 8RF

  • Maidstone Hospital

    Maidstone, England, ME16 9QQ

  • Christie Hospital

    Manchester, England, M20 4BX

  • Clatterbridge Centre for Oncology

    Merseyside, England, CH63 4JY

  • James Cook University Hospital

    Middlesbrough, England, TS4 3BW

  • Northern Centre for Cancer Treatment at Newcastle General Hospital

    Newcastle upon Tyne, England, NE4 6BE

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England, HA6 2RN

  • Derriford Hospital

    Plymouth, England, PL6 8DH

  • Dorset Cancer Centre

    Poole Dorset, England, BH15 2JB

  • Portsmouth Oncology Centre at Saint Mary's Hospital

    Portsmouth Hants, England, PO3 6AD

  • Whiston Hospital

    Prescot Merseyside, England, L35 5DR

  • Berkshire Cancer Centre at Royal Berkshire Hospital

    Reading, England, RG1 5AN

  • Scarborough General Hospital

    Scarborough, England, YO12 6QL

  • Scunthorpe General Hospital

    Scunthorpe, England, DN15 7BH

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England, S1O 2SJ

  • Wexham Park Hospital

    Slough, Berkshire, England, SL2 4HL

  • Southampton General Hospital

    Southampton, England, SO16 6YD

  • University Hospital of North Staffordshire

    Stoke-on-Trent, England, ST4 7LN

  • Torbay Hospital

    Torquay, England, TQ2 7AA

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Conditions
Kidney Cancer
Being tested
sorafenib tosylate, adjuvant therapy
Keywords
stage II renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer, stage I renal cell cancer, clear cell renal cell carcinoma, papillary renal cell carcinoma
Medical subject headings
Kidney Neoplasms, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival

Secondary outcomes (5)

  1. Metastasis-free survival

  2. Disease-specific survival time

  3. Overall survival

  4. Cost effectiveness

  5. Toxicity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionAug 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
1,656 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00492258
Sponsor's protocol ID
MRC-RE05-SORCE
Other IDs
CDR0000553251, EUDRACT ID 2006-006079-19, EU-20734, ISRCTN38934710
Status last verified
Apr 2008
First submitted
25 Jun 2007
Last updated
12 Aug 2013
Results posted
No

Publications

  • Eisen T, Frangou E, Oza B, Ritchie AWS, Smith B, Kaplan R, Davis ID, Stockler MR, Albiges L, Escudier B, Larkin J, Bex A, Joniau S, Hancock B, Hermann GG, Bellmunt J, Hodgkinson E, Stewart GD, Barber J, Brown J, McMenemin R, Nathan P, Pickering LM, Parmar MKB, Meade A. Adjuvant Sorafenib for Renal Cell Carcinoma at Intermediate or High Risk of Relapse: Results From the SORCE Randomized Phase III Intergroup Trial. J Clin Oncol. 2020 Dec 1;38(34):4064-4075. doi: 10.1200/JCO.20.01800. Epub 2020 Oct 14.

    PubMed 33052759

  • Blinman PL, Davis ID, Martin A, Troon S, Sengupta S, Hovey E, Coskinas X, Kaplan R, Ritchie A, Meade A, Eisen T, Stockler MR. Patients' preferences for adjuvant sorafenib after resection of renal cell carcinoma in the SORCE trial: what makes it worthwhile? Ann Oncol. 2018 Feb 1;29(2):370-376. doi: 10.1093/annonc/mdx715.

    PubMed 29177440

  • Fairfax BP, Pratap S, Roberts IS, Collier J, Kaplan R, Meade AM, Ritchie AW, Eisen T, Macaulay VM, Protheroe A. Fatal case of sorafenib-associated idiosyncratic hepatotoxicity in the adjuvant treatment of a patient with renal cell carcinoma. BMC Cancer. 2012 Dec 11;12:590. doi: 10.1186/1471-2407-12-590.

    PubMed 23231599

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sorafenib tosylate and adjuvant therapy in people with Kidney Cancer, run by Medical Research Council at 39 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00492258, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in