Immediate Surgery or Surgery After Sunitinib Malate in Treating Patients With Metastatic Kidney Cancer (SURTIME)
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|ClinicalTrials.gov Identifier: NCT01099423|
Recruitment Status : Active, not recruiting
First Posted : April 7, 2010
Last Update Posted : February 8, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Procedure: timing of surgery Genetic: gene expression analysis Other: biologic sample preservation procedure Other: laboratory biomarker analysis Procedure: therapeutic conventional surgery||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase III Trial Comparing Immediate Versus Deferred Nephrectomy in Patients With Synchronous Metastatic Renal Cell Carcinoma|
|Actual Study Start Date :||April 2010|
|Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||May 2017|
Active Comparator: Immediate nephrectomy
Surgery followed by Sunitinib
|Genetic: gene expression analysis Other: biologic sample preservation procedure Other: laboratory biomarker analysis Procedure: therapeutic conventional surgery|
Experimental: Deferred nephrectomy
Sunitinib (3 cycles) followed by surgery followed by Sunitinib
|Procedure: timing of surgery Genetic: gene expression analysis Other: biologic sample preservation procedure Other: laboratory biomarker analysis|
- Overall progression-free survival
- Overall survival
- Overall response to treatment in the deferred nephrectomy arm including the proportion of patients who become unresectable
- Effect of nephrectomy on early progression in both arms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01099423
|Onze Lieve Vrouw Ziekenhuis|
|Cliniques Universitaires St. Luc|
|Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet|
|Universitair Ziekenhuis Gent|
|Virga Jesse Hospital|
|AZ Groeninghe - Campus Loofstraat|
|AZ Damiaan - Campus Sint-Jozef|
|Canada, Nova Scotia|
|Queen Elizabeth II Health Sciences Centre|
|Halifax, Nova Scotia, Canada|
|CHUM - Pavillon Saint-Luc|
|Montreal,, Quebec, Canada|
|Montreal General Hospital|
|The Ottawa Hospital, The Integrated Cancer Program- General Campus|
|University Health Network - Oci / Princess Margaret Hospital|
|Diamond Health Care Centre|
|San Camillo Forlanini Hospitals|
|Jeroen Bosch Ziekenhuis|
|Academisch Medisch Centrum - Universiteit van Amsterdam|
|The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis|
|Vrije Universiteit Medisch Centrum|
|University Medical Center Groningen|
|Academisch Ziekenhuis Maastricht|
|Radboud University Nijmegen Medical Centre|
|Universitair Medisch Centrum - Academisch Ziekenhuis|
|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|
|Swansea, United Kingdom|
|Study Chair:||Axel Bex||The Netherlands Cancer Institute|
|Study Chair:||John B.A.G. Haanen||The Netherlands Cancer Institute|