Stereotactic Ablative Body Radiation Therapy for Patients With Primary Renal Cancer
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|ClinicalTrials.gov Identifier: NCT02141919|
Recruitment Status : Active, not recruiting
First Posted : May 20, 2014
Last Update Posted : October 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Renal Cancers||Radiation: Stereotactic Ablative Radiation Therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Stereotactic Ablative Body Radiation Therapy (SABR) for Patients With Primary Renal Cancer (RCC)|
|Actual Study Start Date :||June 2013|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||December 2025|
Experimental: Stereotactic Ablative Radiation Therapy
Stereotactic Ablative Radiation Therapy (SABR)
Radiation: Stereotactic Ablative Radiation Therapy
Stereotactic Ablative Body Radiation Therapy (SABR): 3 fractions of 12Gy, or 4 fractions of 10Gy or 5 fractions of 8 Gy
Other Name: SABR
- Eliminate its growth and tumor viability. [ Time Frame: 2 years ]To evaluate if SABR to small renal tumors is able to eliminate its growth and viable tumor.
- Adverse events [ Time Frame: 2 years ]To describe the adverse events associated with the administration of SABR to renal tumors.
- growth rate of renal tumors [ Time Frame: 2 years ]To measure the growth rate of renal tumors after SABR treatment.
- Renal function [ Time Frame: 2 years ]To measure the changes in kidney function, creatinine levels, renal perfusion and GFR after SABR treatment
- Tumor Viability [ Time Frame: one year ]To measure tumor viability pathologically one year after SABR treatment with biopsy.
- progression of disease [ Time Frame: 2 years ]
To assess radiographic changes to the renal tumor after SABR treatment including tumor viability, enhancement necrosis,T2 tumor cellularity with diffusion-weighted imaging. To assess local, regional and systemic progression of disease after SABR to SRM .To assess time to progression (TTP) of disease from the first SABR treatment.
To assess progression free survival (PFS). PFS is defined as the length of time from start of treatment to the time of loco-regional disease progression or death from any cause.
To assess overall survival (OS). OS is defined as the duration of time from start of treatment to the time of death from any cause.
To assess tumor growth, local failure and indeterminate disease response (IDR).
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): NCT02141919
|United States, Texas|
|University of Texas Southwestern|
|Dallas, Texas, United States, 75239|
|Principal Investigator:||Raquibul Hannan, MD, PhD||UTSW|