Clinical trial · Interventional
Sorafenib in Treating Patients at Risk of Relapse After Undergoing Surgery to Remove Kidney Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| sorafenib tosylate | Drug | Sorafenib Tosylate | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Disease-free survival
Secondary outcomes (5)
- measure
- Metastasis-free survival
- measure
- Disease-specific survival time
- measure
- Overall survival
- measure
- Cost effectiveness
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 allowedReferences
Publications (3)
- DERIVEDEisen 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
- DERIVEDBlinman 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
- DERIVEDFairfax 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