SAbR For Oligo-Progressive Renal Cell Cancer.
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 3/27/2019 |
| Start Date: | October 1, 2018 |
| End Date: | October 1, 2024 |
| Contact: | Raquibul Hannan, MD, PhD |
| Email: | Raquibul.Hannan@UTSouthwestern.edu |
| Phone: | 214-645-7696 |
A Phase II Trial of Stereotactic Ablative Radiation Therapy (SAbR) for Patients With Oligo-progressive Renal Cell Cancer (RCC).
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.
Hypothesis:
Stereotactic ablative radiation (SAbR) can delay the change of systemic therapy with
oligoprogressive renal cell cancer (RCC) and improve progression free survival (PFS).
Primary Objectives:
• To evaluate the benefit of SAbR for oligo-progressive mRCC (Metastatic Renal Cell Cancer).
Secondary Objectives:
• To measure the toxicity, safety and tolerance of concurrent systemic therapy and SAbR for
mRCC patients and its impact on quality of life.
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.
Hypothesis:
Stereotactic ablative radiation (SAbR) can delay the change of systemic therapy with
oligoprogressive renal cell cancer (RCC) and improve progression free survival (PFS).
Primary Objectives:
• To evaluate the benefit of SAbR for oligo-progressive mRCC (Metastatic Renal Cell Cancer).
Secondary Objectives:
• To measure the toxicity, safety and tolerance of concurrent systemic therapy and SAbR for
mRCC patients and its impact on quality of life.
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).
Problem Statements:
- 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?
Primary Endpoint:
• Time to change of systemic therapy.
Secondary Endpoint:
- 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.
Ablative Radiation Therapy (SAbR) for patients with oligo-progressive RCC (Renal Cell
Cancer).
Problem Statements:
- 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?
Primary Endpoint:
• Time to change of systemic therapy.
Secondary Endpoint:
- 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.
Inclusion Criteria:
- Metastatic renal cell carcinoma with systemic therapy (oligo-progression defined as ≤3
sites of metastasis).
- Radio-graphic evidence of metastatic disease.
Exclusion Criteria:
- Subjects with ≥3 unfavorable prognostic factors defined by IMDC (International
Metastatic Renal Cell Carcinoma).
- Subjects with history of or new brain metastasis.
We found this trial at
1
site
1801 Inwood Rd
Dallas, Texas 75390
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Neil Desai, MD
Phone: 214-645-8302
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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