Phase II Trial of SAbR for Patients With Oligometastatic Renal Cell Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Oligometastatic Renal Cell Carcinoma
- Sponsor
- University of Texas Southwestern Medical Center
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Time to start of systemic therapy (TTST)
- Status
- Active, not recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Raquibul Hannan
Associate Professor of Medicine
University of Texas Southwestern Medical Center
Eligibility Criteria
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. CT should be performed within 30 days of registration.
- •Pathology confirmation of Renal cell carcinoma.
- •Prior surgery, or radiation is permitted.
- •Age ≥ 18 years.
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, and for 90 days after Radiation treatment has been completed . Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- •Has not undergone a hysterectomy or bilateral oophorectomy; or
- •Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- •Ability to understand and the willingness to sign a written informed consent and agrees to undergo image studies and follow up
Exclusion Criteria
- •Subjects with brain metastasis as assessed by contrast MRI or contrast CT scans(contrast recommended).
- •Subjects with previous history of brain metastasis.
- •Subjects that received prior systemic therapy for kidney cancer in the past 1 year, except one line of immuno- or cytokine therapy (e.g. prior IL-2); systemic therapy for other cancers does not apply to this exclusion criteria
- •Subjects with ≥3 unfavorable prognostic factors defined by Motzer et al. (1999), (KPS \<80% or ECOG\>1, 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 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.
Outcomes
Primary Outcomes
Time to start of systemic therapy (TTST)
Time Frame: 1 Year
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 Outcomes
- Modified progression-free survival (mPFS) for patients who are treated with SAbR(6 years)
- Progression-free survival on systemic therapy (mPFS)(6 years)
- Overall survival (OS)(6 years)
- Time to disease progression that cannot be treated(6 years)
- Health-related quality of life (HRQOL) FKSI(6 years)
- Cancer specific survival (CSS)(6 years)
- Local Control(6 years)
- Acute & Delayed Toxicity(6 years)
- Health-related quality of life (HRQOL) EQ-5D(6 years)
- Median response duration(6 years)
- Time to development of new lesions(6 years)
- Health-related quality of life (HRQOL) FACT-G(6 years)
- Health-related quality of life (HRQOL) cost-effectiveness(6 years)