Immediate Surgery or Surgery After Sunitinib Malate in Treating Patients With Metastatic Kidney Cancer
- Conditions
- Kidney Cancer
- Interventions
- Procedure: timing of surgeryGenetic: gene expression analysisOther: biologic sample preservation procedureOther: laboratory biomarker analysisProcedure: therapeutic conventional surgery
- Registration Number
- NCT01099423
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 99
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Immediate nephrectomy therapeutic conventional surgery Surgery followed by Sunitinib Deferred nephrectomy gene expression analysis Sunitinib (3 cycles) followed by surgery followed by Sunitinib Immediate nephrectomy biologic sample preservation procedure Surgery followed by Sunitinib Immediate nephrectomy laboratory biomarker analysis Surgery followed by Sunitinib Deferred nephrectomy timing of surgery Sunitinib (3 cycles) followed by surgery followed by Sunitinib Deferred nephrectomy biologic sample preservation procedure Sunitinib (3 cycles) followed by surgery followed by Sunitinib Deferred nephrectomy laboratory biomarker analysis Sunitinib (3 cycles) followed by surgery followed by Sunitinib Immediate nephrectomy gene expression analysis Surgery followed by Sunitinib
- Primary Outcome Measures
Name Time Method Overall progression-free survival
- Secondary Outcome Measures
Name Time Method Morbidity Overall survival Effect of nephrectomy on early progression in both arms Overall response to treatment in the deferred nephrectomy arm including the proportion of patients who become unresectable
Trial Locations
- Locations (29)
Academisch Ziekenhuis Maastricht
🇳🇱Maastricht, Netherlands
Radboud University Nijmegen Medical Centre
🇳🇱Nijmegen, Netherlands
Cliniques Universitaires St. Luc
🇧🇪Brussels, Belgium
Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet
🇧🇪Brussels, Belgium
Virga Jesse Hospital
🇧🇪Hasselt, Belgium
Onze Lieve Vrouw Ziekenhuis
🇧🇪Aalst, Belgium
AZ Damiaan - Campus Sint-Jozef
🇧🇪Oostende, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
AZ Groeninghe - Campus Loofstraat
🇧🇪Kortrijk, Belgium
CHUM - Pavillon Saint-Luc
🇨🇦Montreal,, Quebec, Canada
Montreal General Hospital
🇨🇦Montreal, Canada
University Health Network - Oci / Princess Margaret Hospital
🇨🇦Toronto, Canada
The Ottawa Hospital, The Integrated Cancer Program- General Campus
🇨🇦Ottawa, 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
Universitair Medisch Centrum - Academisch Ziekenhuis
🇳🇱Utrecht, Netherlands
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
🇬🇧Bristol, United Kingdom
Royal United Hospital
🇬🇧Bath, United Kingdom
Singelton Hospital
🇬🇧Swansea, 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
St. James'S University Hospital
🇬🇧Leeds, United Kingdom
Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada