Sunitinib Before or After Surgery in Treating Patients With Metastatic Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT00626509|
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : February 29, 2008
Last Update Posted : August 12, 2013
RATIONALE: Sunitinib 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 before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib is more effective when given before or after surgery in treating kidney cancer.
PURPOSE: This randomized phase II trial is studying the side effects of sunitinib and to compare how well it works when given before or after surgery in treating patients with metastatic kidney cancer.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Drug: sunitinib malate Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery||Phase 2|
- To compare the activity of sunitinib malate when administered before vs after cytoreductive nephrectomy, in terms of response rate, in patients with metastatic renal cell carcinoma.
- To compare the safety of these regimens in these patients.
- To compare the time to progression in patients treated with these regimens.
- To compare the duration of response in patients treated with these regimens.
- To compare the overall survival of patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo cytoreductive nephrectomy. Patients then receive adjuvant therapy comprising oral sunitinib malate once daily for 4 weeks. Treatment repeats every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Some patients may continue treatment beyond 1 year at the discretion of the investigator.
- Arm II: Patients receive neoadjuvant therapy comprising oral sunitinib malate once daily for 4 weeks. Treatment repeats every 6 weeks for 2 courses. After completion of neoadjuvant therapy, patients undergo cytoreductive nephrectomy followed by adjuvant sunitinib malate as in arm I.
After completion of study therapy, patients are followed every 2 months for up to 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Official Title:||Sunitinib Either Before or After Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell Carcinoma|
|Study Start Date :||February 2008|
|Estimated Primary Completion Date :||January 2011|
- Overall objective tumor response rate (complete response, partial response, stable disease, and progressive disease) as assessed by RECIST criteria
- Adverse events as assessed by NCI CTCAE v3.0
- Time to progression
- Duration of response
- Overall survival
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): NCT00626509
|Ospedale Sacro Cuore||Recruiting|
|Negrar, Italy, 37024|
|Contact: Contact Person 39-045-601-3912|
|Principal Investigator:||Marco Venturini, MD||Ospedale Sacro Cuore|