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

NCT00492258 | Completed Phase 3

• 5 other identifiers: MRC-RE05-SORCECDR0000553251EUDRACT ID 2006-006079-19EU-20734ISRCTN38934710
• Study Type: interventional
• Target: 1,656
• Locations: 1 country
• Sites: 39

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.

Conditions

Kidney Cancer

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

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

Secondary Outcomes (5)

• Metastasis-free survival

• Disease-specific survival time

• Overall survival

• Cost effectiveness

• Toxicity

Interventions

sorafenib tosylate DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical Research Council: lead

Study Sites (39)

Royal Bournemouth Hospital

Bournemouth, England, BH7 7DW, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Queen's Hospital

Burton-on-Trent, England, DE13 0RB, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Gloucestershire Oncology Centre at Cheltenham General Hospital

Cheltenham, England, GL53 7AN, United Kingdom

Location

Derbyshire Royal Infirmary

Derby, England, DE1 2QY, United Kingdom

Location

Dorset County Hospital

Dorchester, England, DT1 2JY, United Kingdom

Location

Gloucestershire Royal Hospital

Gloucester, England, GL1 3NN, United Kingdom

Location

Diana Princess of Wales Hospital

Grimsby, England, DN33 2BA, United Kingdom

Location

Princess Royal Hospital at Hull and East Yorkshire NHS Trust

Hull, England, HU8 9HE, United Kingdom

Location

Ipswich Hospital

Ipswich, England, IP4 5PD, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Lincoln County Hospital

Lincoln, England, LN2 5QY, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Medical Research Council Clinical Trials Unit

London, England, NW1 2DA, United Kingdom

Location

Guy's Hospital

London, England, SE1 9RT, United Kingdom

Location

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

Location

Charing Cross Hospital

London, England, W6 8RF, United Kingdom

Location

Maidstone Hospital

Maidstone, England, ME16 9QQ, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

Location

James Cook University Hospital

Middlesbrough, England, TS4 3BW, United Kingdom

Location

Northern Centre for Cancer Treatment at Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Derriford Hospital

Plymouth, England, PL6 8DH, United Kingdom

Location

Dorset Cancer Centre

Poole Dorset, England, BH15 2JB, United Kingdom

Location

Portsmouth Oncology Centre at Saint Mary's Hospital

Portsmouth Hants, England, PO3 6AD, United Kingdom

Location

Whiston Hospital

Prescot Merseyside, England, L35 5DR, United Kingdom

Location

Berkshire Cancer Centre at Royal Berkshire Hospital

Reading, England, RG1 5AN, United Kingdom

Location

Scarborough General Hospital

Scarborough, England, YO12 6QL, United Kingdom

Location

Scunthorpe General Hospital

Scunthorpe, England, DN15 7BH, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Wexham Park Hospital

Slough, Berkshire, England, SL2 4HL, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

University Hospital of North Staffordshire

Stoke-on-Trent, England, ST4 7LN, United Kingdom

Location

Torbay Hospital

Torquay, England, TQ2 7AA, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 33052759 DERIVED

• 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.

  PMID: 29177440 DERIVED

• 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.

  PMID: 23231599 DERIVED

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Sorafenib; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Timothy Eisen

  Cancer Research UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 25, 2007
• First Posted: June 27, 2007
• Study Start: June 1, 2007
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 12, 2013

Record last verified: 2008-04

Locations

GB (39)