Prior Axitinib as a Determinant of Outcome of Renal Surgery (PADRES)
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|ClinicalTrials.gov Identifier: NCT03438708|
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : September 20, 2018
This is a single arm phase II study of axitinib in patients with clear cell renal cell carcinoma (RCC) with strong indications for partial nephrectomy (PN) for whom PN is not currently possible due to anatomic considerations and residual renal function concerns. Evaluation of tumor downsizing will be performed including changes of tumor complexity by nephrometry score. A total of 50 participants will be enrolled.
It is hypothesized that pretreatment with axitinib will be safe and improve the feasibility of complex nephron sparing surgery in select patients with localized clear cell RCC and imperative indications for partial nephrectomy.
|Condition or disease||Intervention/treatment||Phase|
|Clear Cell Renal Cell Carcinoma||Drug: Axitinib Oral Tablet [Inlyta]||Phase 2|
The primary objective of the study is to prospectively assess utility of axitinib in facilitation of partial nephrectomy where partial nephrectomy was not thought to be safe/possible in the setting of imperative indication for complex renal masses in renal cell cancer.
Secondary objectives: To determine the safety, tumor diameter (per RECIST v1.1) volume change, surgical morbidity and renal functional outcomes following neoadjuvant axitinib for RCC.
- tumor diameter/volume change,
- conversion of hilar to non-hilar tumors,
- reduction in RENAL morphometric score.
- Requirement of acute dialysis
- Change in Glomerular Filtration Rate (GFR)
- Whether or not GFR crosses 30 threshold, or decline by GFR to >50% of baseline.
- Incidence of Clavien >3 complications
- Avoidance of need for multiple blood transfusions
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||"PADRES" (Prior Axitinib as a Determinant of Outcome of REnal Surgery)|
|Actual Study Start Date :||March 5, 2018|
|Estimated Primary Completion Date :||October 29, 2019|
|Estimated Study Completion Date :||February 1, 2020|
Experimental: Axitinib Oral Tablet [Inlyta]
Axitinib 5 mg PO BID for 8-10 weeks
Drug: Axitinib Oral Tablet [Inlyta]
Axitinib 5 milligrams (mg) administered orally (po) twice daily (BID) for 8 weeks (with titration to 7 mg BID as tolerated at 4 weeks)
Other Name: Inlyta
- Percent reduction of longest diameter of tumor in millimeters [ Time Frame: 90 days ]
- Objective Tumor Response Rate (by RECIST criteria) [ Time Frame: 90 days ]Percentage of patients achieving partial response (reduction in tumor diameter by at least 30% of maximum diameter) as defined by RECIST criteria
- Effect on tumor morphometry, as measured by RENAL score [(R)adius, (E)xophytic/endophytic components, (N)earness to the collecting system or sinus, (A)neterior/posterior, and (L)ocation relative to polar lines] [ Time Frame: 90 days ]The RENAL nephrometry score quantifies tumor size and location relative to the major blood vessel and collecting system supply of the kidney according to 5 domains (tumor radius, exophytic/endophytic appearance, proximity to urinary collecting system, anterior/posterior location, and location with respect to renal poles). Four of these domains have a score of 1-3, with 3 indicating a more complex score within the domain. The total score is the sum of all of the domains (total minimum score being 4 and the maximum score being 12, and with more complex tumors having a higher score). The study will record effect of the medication on tumor complexity as measured by total RENAL nephrometry score.
- Feasibility of partial nephrectomy surgery [ Time Frame: 90 days ]Percentage of Successful partial nephrectomy perfomed (as opposed to radical nephrectomy) with negative surgical margins determined by pathological assessment of resection margins.
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): NCT03438708
|Contact: Candace Winkler, MSemail@example.com|
|Contact: William Brocklehurstfirstname.lastname@example.org|
|United States, California|
|UC San Diego Moores Cancer Center||Recruiting|
|La Jolla, California, United States, 92093|
|Contact: Candace M Winkler, MS 858-822-5398 email@example.com|
|Contact: Arlene Araneta 8588226187 firstname.lastname@example.org|
|Study Chair:||Ithaar H Derweesh, MD||UC San Diego Moores Cancer Center|
|Principal Investigator:||Ithaar H Derweesh, MD||UC San Diego Moores Cancer Center|
|Principal Investigator:||Brian I Rini, MD||The Cleveland Clinic|
|Principal Investigator:||Steven C Campbell, MD, PhD||The Cleveland Clinic|