Clinical trial · Interventional
Immediate Surgery or Surgery After Sunitinib Malate in Treating Patients With Metastatic Kidney Cancer
Randomized Phase III Trial Comparing Immediate Versus Deferred Nephrectomy in Patients With Synchronous Metastatic Renal Cell Carcinoma
- 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: Sunitinib malate 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 sunitinib malate before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving sunitinib malate after surgery may kill any tumor cells that remain after surgery. It is not yet known whether undergoing immediate surgery or surgery after sunitinib malate is more effective in treating patients with metastatic kidney cancer. PURPOSE: This randomized phase III trial is studying immediate surgery to see how well it works compared with surgery after sunitinib malate in treating patients with metastatic 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biologic sample preservation procedure | Other | — | UNRESOLVED |
| gene expression analysis | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
| timing of surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Immediate nephrectomy
- description
- Surgery followed by Sunitinib
- interventionNames
- Genetic: gene expression analysis
- Other: biologic sample preservation procedure
- Other: laboratory biomarker analysis
- Procedure: therapeutic conventional surgery
- type
- EXPERIMENTAL
- label
- Deferred nephrectomy
- description
- Sunitinib (3 cycles) followed by surgery followed by Sunitinib
- interventionNames
- Procedure: timing of surgery
- Genetic: gene expression analysis
- Other: biologic sample preservation procedure
- Other: laboratory biomarker analysis
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed renal cell cancer (RCC)
* Clear-cell subtype with a resectable asymptomatic in situ primary
* Asymptomatic primary is defined as the absence of symptoms\* which can be exclusively assigned to the primary tumor such as flank pain and/or gross hematuria necessitating blood transfusion NOTE: \*Para-neoplastic symptoms cannot be assigned to the primary tumor alone in metastatic disease, they are not included in this definition.
* No symptomatic primary tumor necessitating nephrectomy
* Resectable primary tumor
* Bulky locoregional lymph node metastases larger than the primary tumor allowed provided resectability of the lymph nodes is surgically feasible
* Metastatic RCC
* Distant metastases are not completely resectable at the time of surgery or during an additional intervention
* No multiple distant lesions at one site
* No bone-only metastases
* Measurable disease, both primary and metastatic, according to RECIST 1.1 criteria
* Planning to receive sunitinib malate as background therapy
* Patients with \> 3 of the following surgical risk factors are not eligible:
* Serum albumin CTCAE v 4.0 grade 2 or worse
* Serum LDH \> 1.5 times upper limit of normal
* Liver metastases
* Symptoms at presentation due to metastases
* Retroperitoneal lymph node involvement
* Supra-diaphragmatic lymph node involvement
* Clinical stage T3 or T4 disease
* No clinical signs of CNS involvement
PATIENT CHARACTERISTICS:
* See Disease Characteristics
* WHO performance status 0-1
* Life expectancy \> 3 months
* WBC \> 3.0 x 10\^9/L
* Platelet count \> 100 x 10\^9/L
* Hemoglobin \> 10.0 g/dL
* PT/PTT or INR ≤ 1.2 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN
* ALT ≤ 2.5 times ULN (≤ 5 times ULN if liver lesions)
* Serum calcium \< 10.0 mg/dL
* Calculated or measured creatinine clearance \> 30 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception 2 weeks before and during study treatment
* LVEF normal by MUGA scan or ECHO
* 12-lead ECG normal
* No serious cardiac illness (myocardial infarction and/or treatable or untreatable angina pectoris not responding to treatment) within the past 12 months
* No uncontrolled, high BP (≥ 150/100 mm Hg) despite optimal medical therapy
* No current pulmonary disease
* No active or uncontrolled infections, serious illnesses, malabsorption syndrome, or medical conditions, including patients with a history of chronic alcohol abuse, hepatitis, HIV, and/or cirrhosis
* No malignancies within the past 5 years except renal cell carcinoma, basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, resected incidental prostate cancer staged pT2 with Gleason Score ≤ 6 and postoperative PSA \< 0.5 ng/mL, or patients with any history of malignancies who are disease-free for more than 5 years
* No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
PRIOR CONCURRENT THERAPY:
* Prior local radiotherapy for bone lesions allowed
* No prior systemic therapy for metastatic RCC
* No prior partial or total nephrectomy
* No concurrent systemic corticosteroid and/or other immunosuppressive systemic therapies
* No concurrent radiotherapy, except palliative radiotherapy
* No concurrent participation in another clinical trial testing treatments for any disease including renal cell carcinoma
* No other concurrent investigational or systemic therapy for metastatic RCCReferences
Publications (3)
- DERIVEDBex A, Mulders P, Jewett M, Wagstaff J, van Thienen JV, Blank CU, van Velthoven R, Del Pilar Laguna M, Wood L, van Melick HHE, Aarts MJ, Lattouf JB, Powles T, de Jong Md PhD IJ, Rottey S, Tombal B, Marreaud S, Collette S, Collette L, Haanen J. Comparison of Immediate vs Deferred Cytoreductive Nephrectomy in Patients With Synchronous Metastatic Renal Cell Carcinoma Receiving Sunitinib: The SURTIME Randomized Clinical Trial. JAMA Oncol. 2019 Feb 1;5(2):164-170. doi: 10.1001/jamaoncol.2018.5543. PMID 30543350
- DERIVEDLeon L, Garcia-Figueiras R, Suarez C, Arjonilla A, Puente J, Vargas B, Mendez Vidal MJ, Sebastia C. Recommendations for the clinical and radiological evaluation of response to treatment in metastatic renal cell cancer. Target Oncol. 2014 Mar;9(1):9-24. doi: 10.1007/s11523-013-0304-7. Epub 2013 Dec 12. PMID 24338498
- DERIVEDWinquist E, Rodrigues G. Open clinical uro-oncology trials in Canada. Can J Urol. 2012 Dec;19(6):6587-91. No abstract available. PMID 23228299