Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377722
Status:
TERMINATED
Last Update Posted:
2024-04-26
First Post:
2024-04-17
Brief Title:
Cabozantinib Treatment Prior to Cytoreductive Nephrectomy in Patients With Advanced or Metastatic Renal Cells Cancer
Sponsor:
Fundacion Oncosur
Organization:
Fundacion Oncosur
Study Overview
Official Title:
Phase II Study for the Evaluation of Neoadjuvant Treatment With Cabozantinib Pior to Cytoreductive Nephrectomy in Patients With Advanced or Metastatic Renal Cells Cancer
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The achieved number of samples has been smaller than the planned 50 thus a mainly descriptive final result analysis was conducted as presented herein
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 cancermetastases 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None