Phase II, multicenter, national, uncontrolled, multicenter, uncontrolled, phase II clinical trial for the evaluation of cabozantinib treatment prior to cytoreductive nephrectomy in patients with advanced or metastatic renal cell cancer candidates for primary tumor cytoreductive nephrectomy (NC).
Metastatic Renal cell carcinoma (RCC) is a type of kidney cancer that arises in the small tubes of the kidneys and has spread to other parts of the body (advanced cancer/metastases). Patients typically have surgery to remove a part or all of their kidney (called partial or radical nephrectomy). Other treatments include chemotherapy, targeted therapy, immunotherapy and hormone therapy and may be used before or after surgery or radiotherapy. There is no standard drug therapy given before surgery, but such preoperative therapy is used widely in the treatment of other cancer types. This approach has several potential advantages, including shrinking the tumor to help improve surgical outcomes and to help find an appropriate drug therapy. Cabozantinib is the generic for the trade chemotherapy drug CABOMETYX™ (cabozantinib). It is known as a cancer growth inhibitor and also an angiogenesis inhibitor. Tyrosine kinases are proteins that control how cells grow and divide. By blocking the activity of these proteins in cancer cells, the medicine reduces the growth and spread of cancer. This study tries to clarify whether Cabozantinib could be a safe and effective preoperative treatment in patients with advanced RCC who were candidates for removing a part or all of their kidney.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
This study tries to clarify whether Cabozantinib could be a safe and effective preoperative treatment in patients with advanced RCC who were candidates for removing a part or all of their kidney.
Institut Català d'Oncologia. Idibell
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Univeristario 12 de Octubre
Madrid, Spain
Radiological response rate prior to cytoreductive nephrectomy
Objective response to preoperative treatment with cabozantinib, defined as the percentage of patients that reach complete or partial radiological response after a 12-week cycle of treatment with cabozantinib, defined according to the RECIST 1.1 criteria (Response Evaluation Criteria In Solid Tumors: complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD))
Time frame: At 12 weeks following the start of the treatment.
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Centro Oncológico Clara Campal - HM CIOCC
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Universitario Severo Ochoa
Madrid, Spain