Immediate Surgery or Surgery After Sunitinib Malate in Treating Patients With Metastatic Kidney Cancer
NCT ID: NCT01099423
Last Updated: 2017-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
99 participants
INTERVENTIONAL
2010-04-30
2017-05-31
Brief Summary
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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.
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Detailed Description
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* To determine if immediate versus deferred nephrectomy has an effect on disease control in patients with resectable, synchronous, metastatic renal cell carcinoma treated with sunitinib malate.
* To identify potential response criteria based on histopathology and molecular research on tumor tissue.
OUTLINE: This is a multicenter study. Patients are stratified according to WHO performance status (0 vs 1), number of metastatic sites (1 vs 2 or more), and institution. Patients are randomized to 1 of 2 treatment arms.
* Arm I (immediate nephrectomy): Patients undergo cytoreductive nephrectomy. Beginning 4 weeks after surgery, patients receive oral sunitinib malate once daily on days 1-28. Treatment with sunitinib malate repeats every 6 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
* Arm II (deferred nephrectomy): Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. About 1 day after completion of sunitinib malate, patients undergo cytoreductive nephrectomy. Patients then receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Some patients undergo tumor tissue collection at baseline and at time of surgery to assess possible differences in gene expression. Patients also undergo blood sample collection periodically to evaluate the potential impact of serum proteins on the clinical outcome. Samples are then stored for future studies.
After completion of study treatment, patients are followed periodically.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Immediate nephrectomy
Surgery followed by Sunitinib
gene expression analysis
biologic sample preservation procedure
laboratory biomarker analysis
therapeutic conventional surgery
Deferred nephrectomy
Sunitinib (3 cycles) followed by surgery followed by Sunitinib
timing of surgery
gene expression analysis
biologic sample preservation procedure
laboratory biomarker analysis
Interventions
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timing of surgery
gene expression analysis
biologic sample preservation procedure
laboratory biomarker analysis
therapeutic conventional surgery
Eligibility Criteria
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Inclusion Criteria
* 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 RCC
18 Years
120 Years
ALL
No
Sponsors
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Wales Cancer Trials Unit
OTHER
Canadian Urologic Oncology Group
OTHER
Institute of Cancer Research, United Kingdom
OTHER
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Axel Bex
Role: STUDY_CHAIR
The Netherlands Cancer Institute
John B.A.G. Haanen
Role: STUDY_CHAIR
The Netherlands Cancer Institute
Locations
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Onze Lieve Vrouw Ziekenhuis
Aalst, , Belgium
Cliniques Universitaires St. Luc
Brussels, , Belgium
Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Virga Jesse Hospital
Hasselt, , Belgium
AZ Groeninghe - Campus Loofstraat
Kortrijk, , Belgium
AZ Damiaan - Campus Sint-Jozef
Ostend, , Belgium
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
CHUM - Pavillon Saint-Luc
Montreal, Quebec, Canada
Montreal General Hospital
Montreal, , Canada
The Ottawa Hospital, The Integrated Cancer Program- General Campus
Ottawa, , Canada
University Health Network - Oci / Princess Margaret Hospital
Toronto, , Canada
Diamond Health Care Centre
Vancouver, , Canada
San Camillo Forlanini Hospitals
Roma, , Italy
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Academisch Medisch Centrum - Universiteit van Amsterdam
Amsterdam, , Netherlands
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
Amsterdam, , Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, , Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, , Netherlands
Universitair Medisch Centrum - Academisch Ziekenhuis
Utrecht, , Netherlands
Royal United Hospital
Bath, , United Kingdom
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
Bristol, , United Kingdom
St. James'S University Hospital
Leeds, , United Kingdom
Barts and The London NHS Trust - St. Bartholomew'S Hospital
London, , United Kingdom
Imperial College Healthcare NHS Trust - Charing Cross Hospital
London, , United Kingdom
Christie NHS Foundation Trust
Manchester, , United Kingdom
Singelton Hospital
Swansea, , United Kingdom
Countries
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References
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Bex 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.
Leon 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.
Winquist E, Rodrigues G. Open clinical uro-oncology trials in Canada. Can J Urol. 2012 Dec;19(6):6587-91. No abstract available.
Other Identifiers
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EU-21022
Identifier Type: -
Identifier Source: secondary_id
PFIZER-EORTC-30073
Identifier Type: -
Identifier Source: secondary_id
EORTC-30073
Identifier Type: -
Identifier Source: org_study_id
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