Neoadjuvant Axitinib in Locally Advanced Renal Cell Carcinoma (RCC)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01263769|
Recruitment Status : Active, not recruiting
First Posted : December 21, 2010
Results First Posted : February 3, 2022
Last Update Posted : February 3, 2022
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Drug: Axitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Clinical Trial Examining the Impact Of Neoadjuvant Axitinib On Primary Tumor Response In Patients With Locally Advanced Clear Cell Renal Cell Carcinoma|
|Actual Study Start Date :||February 2011|
|Actual Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2022|
Axitinib Starting dose: 5 mg by mouth twice each day for 12 weeks.
Starting dose: 5 mg by mouth twice each day for 12 weeks.
Other Name: AG-013736
- Objective Response Rate [ Time Frame: 12 weeks ]Objective response rate is defined as Complete Response (CR)+ Partial Response (PR) and evaluated when CT abdomen is done after 12 weeks of treatment. Per Response Evaluation Criteria in Solid Tumors Criteria ( RECIST v1.0) Complete Response (CR) is complete disappearance of renal mass; and, Partial Response (PR) is >= 30% decrease in the largest diameter (LD) of the renal mass taking as reference the baseline largest diameter.
- Disease-Free Survival [ Time Frame: From randomization until death or up to 10 years ]Disease-free survival is the time from on-treatment to first relapse or death (whichever comes first). Disease free survival was estimated using the Kaplan-Meier method. Participants are still being followed for the secondary outcome measures.
- Overall Survival [ Time Frame: From randomization until death or up to 10 years ]Overall survival is defined as the time from randomization until death due to any cause. Overall Survival was estimated using the Kaplan-Meier method. Participants are still being followed for the secondary outcome measures.
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): NCT01263769
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Christopher Wood, MD||M.D. Anderson Cancer Center|