SAbR For Oligometastatic Renal Cell Carcinoma

The University of Texas System (UT)

Status and phase: Active, not recruiting; Phase 2

Conditions: Oligometastatic Renal Cell Carcinoma

Treatments: Radiation: Stereotactic ablative body radiation (SABR)

Study type: Interventional

Funder types: Other

Identifiers

NCT02956798

STU 042016-046

Details and patient eligibility

About

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).

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Stereotactic ablative body radiation (SABR)

Experimental group

Description:

Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR.

Treatment:

Radiation: Stereotactic ablative body radiation (SABR)