Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-13 @ 7:52 AM
Study NCT ID:
NCT00492258
Status:
COMPLETED
Last Update Posted:
2013-08-12
First Post:
2007-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sorafenib in Treating Patients at Risk of Relapse After Undergoing Surgery to Remove Kidney Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077157', 'term': 'Sorafenib'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}], 'ancestors': [{'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1656}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-09', 'studyFirstSubmitDate': '2007-06-25', 'studyFirstSubmitQcDate': '2007-06-25', 'lastUpdatePostDateStruct': {'date': '2013-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival'}], 'secondaryOutcomes': [{'measure': 'Metastasis-free survival'}, {'measure': 'Disease-specific survival time'}, {'measure': 'Overall survival'}, {'measure': 'Cost effectiveness'}, {'measure': 'Toxicity'}]}, 'conditionsModule': {'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'], 'conditions': ['Kidney Cancer']}, 'referencesModule': {'references': [{'pmid': '33052759', 'type': 'DERIVED', 'citation': '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': '29177440', 'type': 'DERIVED', 'citation': "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': '23231599', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\n* 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.\n\nOUTLINE: This is a randomized, placebo-controlled, double-blind, open-label, multicenter study. Patients are randomized to 1 of 3 treatment arms.\n\n* Arm I: Patients receive oral placebo twice daily for 3 years in the absence of disease progression or unacceptable toxicity.\n* 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.\n* Arm III: Patients receive oral sorafenib tosylate twice daily for 3 years in the absence of disease progression or unacceptable toxicity.\n\nPatients in arms I and II with progressive disease may cross over and receive treatment in arm III.\n\nAfter completion of study treatment, patients are followed periodically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed renal cell carcinoma (RCC)\n\n * Clear cell or non-clear cell tumors allowed\n * Intermediate- or high-risk disease (Leibovich score 3 to 11)\n* Must have undergone surgery for RCC at least 4 weeks but no more than 3 months prior to study entry\n\n * No evidence of residual macroscopic disease on post-operative CT scan after resection of RCC\n\nPATIENT CHARACTERISTICS:\n\n* WHO performance status 0-1\n* WBC \\> 3,400/mm³\n* Platelet count \\> 99,000/mm³\n* Creatinine \\< 2.5 times upper limit of normal (ULN)\n* Liver function tests \\< 1.5 times ULN\n* Serum amylase \\< 1.5 times ULN\n* PT/INR \\< 1.5 times ULN\n* PTT \\< 1.5 times ULN\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 9 months after completion of study treatment\n* No cardiovascular conditions, including any of the following:\n\n * Cardiac arrhythmias requiring anti-arrhythmic medication\n\n * Beta-blockers and digoxin allowed\n * Symptomatic coronary artery disease or ischemia\n * Myocardial infarction within the past 6 months\n * NYHA class II-IV congestive heart failure\n* No active clinically serious bacterial or fungal infection\n* No known history of HIV infection\n* No chronic hepatitis B or C\n* No other prior malignancy except carcinoma in situ of the cervix or adequately treated basal cell carcinoma\n* No uncontrolled hypertension\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No prior treatment for RCC other than nephrectomy\n* More than 30 days since prior and no other concurrent investigational therapy\n* No concurrent medications that have adverse interactions with sorafenib tosylate including, but not limited to, any of the following:\n\n * Rifampin\n * Grapefruit juice\n * Ritonavir\n * Ketoconazole\n * Itraconazole\n * Hypericum perforatum (St John's wort)\n* No concurrent bone marrow transplant or stem cell rescue\n* No other concurrent drug that targets angiogenesis, especially VEGF or VEGF receptors (e.g., bevacizumab)\n* No other concurrent drug that targets Ras-pathway or EGFR\n* No other concurrent anticancer therapy (chemotherapy, immunotherapy, signal transduction inhibition, or hormonal therapy)\n* Concurrent non-conventional therapies (e.g., herbs or acupuncture) and vitamin or mineral supplements allowed\n* Concurrent bisphosphonates for prophylaxis of osteoporosis allowed"}, 'identificationModule': {'nctId': 'NCT00492258', 'briefTitle': 'Sorafenib in Treating Patients at Risk of Relapse After Undergoing Surgery to Remove Kidney Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'MRC-RE05-SORCE'}, 'secondaryIdInfos': [{'id': 'CDR0000553251', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'EUDRACT ID 2006-006079-19'}, {'id': 'EU-20734'}, {'id': 'ISRCTN38934710'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'sorafenib tosylate', 'type': 'DRUG'}, {'name': 'adjuvant therapy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BH7 7DW', 'city': 'Bournemouth', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Bournemouth Hospital', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'zip': 'BS2 8ED', 'city': 'Bristol', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Bristol Haematology and Oncology Centre', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'DE13 0RB', 'city': 'Burton-on-Trent', 'state': 'England', 'country': 'United Kingdom', 'facility': "Queen's Hospital", 'geoPoint': {'lat': 52.80728, 'lon': -1.64263}}, {'zip': 'CB2 2QQ', 'city': 'Cambridge', 'state': 'England', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'GL53 7AN', 'city': 'Cheltenham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Gloucestershire Oncology Centre at Cheltenham General Hospital', 'geoPoint': {'lat': 51.90006, 'lon': -2.07972}}, {'zip': 'DE1 2QY', 'city': 'Derby', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Derbyshire Royal Infirmary', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}, {'zip': 'DT1 2JY', 'city': 'Dorchester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Dorset County Hospital', 'geoPoint': {'lat': 50.71667, 'lon': -2.43333}}, {'zip': 'GL1 3NN', 'city': 'Gloucester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Gloucestershire Royal Hospital', 'geoPoint': {'lat': 51.86568, 'lon': -2.2431}}, {'zip': 'DN33 2BA', 'city': 'Grimsby', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Diana Princess of Wales Hospital', 'geoPoint': {'lat': 53.56539, 'lon': -0.07553}}, {'zip': 'HU8 9HE', 'city': 'Hull', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Princess Royal Hospital at Hull and East Yorkshire NHS 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-2.23743}}, {'zip': 'CH63 4JY', 'city': 'Merseyside', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Clatterbridge Centre for Oncology'}, {'zip': 'TS4 3BW', 'city': 'Middlesbrough', 'state': 'England', 'country': 'United Kingdom', 'facility': 'James Cook University Hospital', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}, {'zip': 'NE4 6BE', 'city': 'Newcastle upon Tyne', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Northern Centre for Cancer Treatment at Newcastle General Hospital', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'HA6 2RN', 'city': 'Northwood', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Mount Vernon Cancer Centre at Mount Vernon Hospital', 'geoPoint': {'lat': 51.61162, 'lon': -0.42454}}, {'zip': 'PL6 8DH', 'city': 'Plymouth', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Derriford Hospital', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'BH15 2JB', 'city': 'Poole Dorset', 'state': 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