Neoadjuvant Cabozantinib in Treating Patients With Locally Advanced Kidney Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04022343|
Recruitment Status : Recruiting
First Posted : July 17, 2019
Last Update Posted : August 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Clear Cell Renal Cell Carcinoma Renal Cell Carcinoma Stage III Renal Cell Cancer AJCC v8||Drug: Cabozantinib||Phase 2|
I. To assess the objective response rate (complete and partial responses), following the administration of cabozantinib for 12 weeks in patients with locally advanced biopsy-proven non-metastatic clear cell renal cell carcinoma (ccRCC) prior to undergoing surgery.
I. To assess the safety, and tolerability of neoadjuvant cabozantinib.
II. To determine the clinical outcome (disease-free survival [DFS], overall survival [OS]) of patients with non-metastatic ccRCC who treated with neoadjuvant cabozantinib.
III. To evaluate the surgery related outcomes.
IV. To evaluate correlative studies, including biomarkers, quality of life, and frailty/sarcopenia assessment of patients with non-metastatic ccRCC who treated with neoadjuvant cabozantinib.
Patients receive cabozantinib orally (PO) once daily (QD) for 12 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Neoadjuvant Cabozantinib in Patients With Locally Advanced Non-Metastatic Clear Cell Renal Cell Carcinoma|
|Actual Study Start Date :||August 6, 2019|
|Estimated Primary Completion Date :||August 31, 2020|
|Estimated Study Completion Date :||August 31, 2023|
Experimental: Treatment (cabozantinib)
Patients receive cabozantinib orally once daily for 12 weeks in the absence of disease progression or unacceptable toxicity. The assigned starting dose for cabozantinib is 60 mg/day. Two dose reduction levels of cabozantinib are permitted
- Objective response rate (ORR) [ Time Frame: At 12 weeks after cabozantinib dose ]
Objective response rate will be evaluated using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) criteria. All tumor measurements must be recorded in centimeters.
For target lesions, a complete response (CR) is defined as the disappearance of all target lesions. A partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.
- Disease-free survival (DFS) [ Time Frame: From time of surgery to first tumor recurrence or death, assessed up to 3 years ]Disease-free survival will be defined as the interval between time of surgery and the first tumor recurrence or death. Patients will be censored at time of last follow-up. Disease-free survival will be estimated with the Kaplan-Meier method.
- Overall survival (OS) [ Time Frame: From time of surgery to death from any cause, assessed up to 3 years ]For overall survival, death from any cause will be defined as the event. Patients will be censored at time of last follow-up. Overall survival will be estimated with the Kaplan-Meier method.
- Quality of life assessment: Functional Assessment of Cancer Therapy-Kidney Specific Index-19 (FKSI-19) questionnaire [ Time Frame: Baseline and weeks 6 and 12 after treatment initiation ]Quality of life will be studied using the Functional Assessment of Cancer Therapy-Kidney Specific Index-19 (FKSI-19) questionnaire. The questionnaire consists of 19 statements such as "I have a lack of energy" and "I have pain" which are answered on a scale of 0-4, with 0 being "Not at all" and 4 being "Very much."
- Frailty assessment [ Time Frame: Baseline and weeks 6 and 12 after treatment initiation ]Frailty assessment will be studied using the Fried Frailty score. Domains to be assessed include shrinking, weakness, exhaustion, low activity, and slow walking speed. Each domain yields a dichotomous score of 0 or 1. Totaled scores classify patients as not frail (0-1), intermediate frail (2-3), and frail (4-5).
- Sarcopenia assessment [ Time Frame: Baseline and week 12 after treatment initiation ]Sarcopenia assessment will be done by using baseline and week 12 scans via SliceOmatic version 5.0 by TomoVision program.
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): NCT04022343
|Contact: Mehmet Asim Bilen, MDfirstname.lastname@example.org|
|Contact: Viraj Master, MD, PhDemail@example.com|
|United States, Georgia|
|Emory University Hospital/Winship Cancer Institute||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Wilena Session 404-778-3448 firstname.lastname@example.org|
|Contact: Stephanie Giles 404-778-4162 email@example.com|
|Principal Investigator:||Mehmet Asim Bilen, MD||Emory University|