SAbR For Oligo-Progressive Renal Cell Cancer.
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|ClinicalTrials.gov Identifier: NCT03696277|
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : March 25, 2019
Metastatic kidney cancer patients on systemic therapy often develop resistance to limited sites that leads to changing of the systemic therapy. Local therapy to the sites of progression may allow patients to continue on the same systemic therapy that is otherwise effective and being tolerated well.
Stereotactic ablative radiation (SAbR) can delay the change of systemic therapy with oligoprogressive renal cell cancer (RCC) and improve progression free survival (PFS).
• To evaluate the benefit of SAbR for oligo-progressive mRCC (Metastatic Renal Cell Cancer).
• To measure the toxicity, safety and tolerance of concurrent systemic therapy and SAbR for mRCC patients and its impact on quality of life.
|Condition or disease||Intervention/treatment||Phase|
|Oligoprogressive Renal Cell Carcinoma||Radiation: Stereotactic ablative body radiation (SABR)||Phase 2|
The study is a prospective phase II, single arm, open label trial evaluating Stereotactic Ablative Radiation Therapy (SAbR) for patients with oligo-progressive RCC (Renal Cell Cancer).
- Can local therapy (SAbR) for oligoprogression delay the change of systemic therapy if progression is minimal to the progressive sites?
- Safely delaying the change of systemic therapy can have significant quality of life benefits for patients with oligo-progressive RCC.
- Can SAbR potentially improve progression free survival in oligoprogressive RCC patients?
• Time to change of systemic therapy.
- To measure the toxicity, safety and tolerance.
- To evaluate the progression free survival (PFS) on subsequent systemic therapy after progression on SAbR.
- To measure the impact on health-related quality of life (HRQOL).
- To evaluate local control of SAbR for RCC
Sample Size: 20 Patients
Statistical Analysis: Time to event will be estimated using the Kaplan-Meier approach along with the 95% confidence interval.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Stereotactic Ablative Radiation Therapy (SAbR) for Patients With Oligo-progressive Renal Cell Cancer (RCC).|
|Actual Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||October 1, 2020|
|Estimated Study Completion Date :||October 1, 2024|
Experimental: Stereotactic ablative body radiation (SABR)
SAbR will be used to treat all sites of measurable metastases. New sites of metastasis will be treated if deemed appropriate by both medical and radiation oncologists with SAbR.
Radiation: Stereotactic ablative body radiation (SABR)
SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
- Time to change of systemic therapy [ Time Frame: 2 Years ]SAbR for oligo-progression will be measured to delay the change of systemic therapy.
- Progression-free survival (PFS) [ Time Frame: 6 years ]Progression-Free Survival on systemic therapy started (PFS-ST) after progression on SAbR with existing or new progression at >3 or >30% of all lesions.
- Acute & Delayed Toxicity [ Time Frame: 6 Years ]Severity or Toxicity will be assessed according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. The consequences of toxicity should all be graded 1-5 according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
- Local Control [ Time Frame: 6 Years ]Radiographic progression with >20% increase in the longest diameter of the treated lesions.
- Health-related quality of life (HRQOL) [ Time Frame: 6 Years ]HRQOL will be measured using FACT-G.
- Health-related quality of life (HRQOL) [ Time Frame: 6 years ]HRQOL will be measured using EQ-5D-5L.
- Quality of life (QOL) [ Time Frame: 6 years ]HRQOL will be measured using FKSI.
- Quality of life with cost involved [ Time Frame: 6 years ]QOL will be measured using Cost & Convenience Questionnaire.
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): NCT03696277
|Contact: Raquibul Hannan, MD, PhD||214-645-7696||Raquibul.Hannan@UTSouthwestern.edu|
|Contact: Samantha Mannala||2146481873||Samantha.Mannala@UTSouthwestern.edu|
|United States, Texas|
|University of Texas Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Neil B Desai, MD 214-645-8302 Neil.Desai@UTSouthwestern.edu|
|Contact: Samantha Mannala 2146481873 Samantha.Mannala@UTSouthwestern.edu|
|Principal Investigator: Neil Desai, MD|
|Principal Investigator:||Raquibul Hannan, MD, PhD||University of Texas|