SAbR For Oligometastatic Renal Cell Carcinoma
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 3/27/2019 |
| Start Date: | July 19, 2018 |
| End Date: | December 31, 2021 |
| Contact: | Raquibul Hannan, MD, PhD |
| Email: | Raquibul.Hannan@UTSouthwestern.edu |
| Phone: | 214-645-7696 |
Phase II Trial of SAbR for Patients With Oligometastatic Renal Cell Carcinoma
Hypothesis:
Stereotactic ablative body radiation (SAbR) prolongs progression-free survival for patients
with oligometastatic kidney cancer (RCC) and delays the initiation of systemic therapy.
Primary Objectives:
• To evaluate the delay in time to start of systemic therapy (TTST) as a surrogate of
progression free survival (PFS), defined as the time from the first day of SAbR to start of
systemic therapy.
Secondary Objective:
- To evaluate the modified progression-free survival (mPFS) for patients with
oligometastatic renal cell carcinoma who are treated with SAbR.
- To evaluate the overall survival (OS)
- To evaluate the cancer specific survival (CSS)
- To evaluate the local control rate of irradiated lesions.
- To measure the health-related quality of life (HRQOL).
Stereotactic ablative body radiation (SAbR) prolongs progression-free survival for patients
with oligometastatic kidney cancer (RCC) and delays the initiation of systemic therapy.
Primary Objectives:
• To evaluate the delay in time to start of systemic therapy (TTST) as a surrogate of
progression free survival (PFS), defined as the time from the first day of SAbR to start of
systemic therapy.
Secondary Objective:
- To evaluate the modified progression-free survival (mPFS) for patients with
oligometastatic renal cell carcinoma who are treated with SAbR.
- To evaluate the overall survival (OS)
- To evaluate the cancer specific survival (CSS)
- To evaluate the local control rate of irradiated lesions.
- To measure the health-related quality of life (HRQOL).
The study is a prospective single institution phase II single-arm open-label trial evaluating
SAbR in patients with newly diagnosed oligometastatic RCC.
Problem Statements:
- Can local therapy (SAbR) safely delay the start of systemic therapy?
- Safely delaying the start of systemic therapy can have significant quality of life
benefits for patients since systemic therapy has significant side effects.
- Can SAbR be curative in truly oligometastatic RCC patients?
Primary Endpoint:
• Time to start of systemic therapy (TTST) defined as the time from the first day of SAbR to
start of systemic therapy.
Secondary Endpoint:
- Modified progression-free survival (mPFS) is defined as the survival interval without
development of >3 sites of new metastasis, new sites of metastases that are not amenable
to SAbR treatment, a total of >6 sites of metastasis that required SAbR, local failure
at SAbR-treated site, or development of brain metastasis.
- Overall Survival
- Local control
- Toxicity
- HRQOL
Sample Size: 23 Patients will be enrolled.
Statistical Analysis: Time to event will be estimated using the Kaplan-Meier approach along
with the 95% confidence interval.
SAbR in patients with newly diagnosed oligometastatic RCC.
Problem Statements:
- Can local therapy (SAbR) safely delay the start of systemic therapy?
- Safely delaying the start of systemic therapy can have significant quality of life
benefits for patients since systemic therapy has significant side effects.
- Can SAbR be curative in truly oligometastatic RCC patients?
Primary Endpoint:
• Time to start of systemic therapy (TTST) defined as the time from the first day of SAbR to
start of systemic therapy.
Secondary Endpoint:
- Modified progression-free survival (mPFS) is defined as the survival interval without
development of >3 sites of new metastasis, new sites of metastases that are not amenable
to SAbR treatment, a total of >6 sites of metastasis that required SAbR, local failure
at SAbR-treated site, or development of brain metastasis.
- Overall Survival
- Local control
- Toxicity
- HRQOL
Sample Size: 23 Patients will be enrolled.
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 limited measurable extracranial metastases
(Limited metastases, or oligometastases, defined as ≤3 sites of metastasis).
- Radiographic evidence of metastatic disease.
- For previous established metastatic status, repeat biopsy is not required.
- Prior surgery, or radiation is permitted.
Exclusion Criteria:
- Subjects with brain metastasis as assessed by contrast MRI or contrast CT scans.
- Subjects with previous history of brain metastasis.
- Subjects received prior systemic therapy, except one line of immuno- or cytokine
therapy (e.g. prior IL-2 or any single or combination of checkpoint inhibitors)
- Subjects with ≥3 unfavorable prognostic factors defined by Motzer et al. (1999), (KPS
<80 %, Hgb < LLN, LDH >1.5x normal, corrected serum calcium >10mg/dl and absence of
prior nephrectomy), Patients with 0, 1-2, and ≥3 factors had time to death of 20
months, 10 months and 4 months.
- Subjects with life expectancy < 6 months.
- Subjects may not be receiving any other investigational agents.
- Subjects must not be pregnant due to the potential for congenital abnormalities and
the potential of this regimen to harm nursing infants.
We found this trial at
1
site
1801 Inwood Rd
Dallas, Texas 75390
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Raquibul Hannan, MD, PhD
Phone: 214-645-7696
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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