NCT03696277

SAbR For Oligo-Progressive Renal Cell Cancer.

A Phase II Trial of Stereotactic Ablative Radiation Therapy (SAbR) for Patients With Oligo-progressive Renal Cell Cancer (RCC).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: * PFS on subsequent systemic therapy (PFS-SST) after progression on SAbR. * Overall survival(OS). * Toxicity, safety and tolerance. * Impact on health-related quality of life (HRQoL). Sample Size: 20 Patients Statistical Analysis: Time to event will be estimated using the Kaplan-Meier approach along with the 95% confidence interval.

Conditions

• Oligoprogressive Renal Cell Carcinoma

Interventions

Type	Name	Description
RADIATION	Stereotactic ablative body radiation (SABR)	SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.

Timeline

• Start date: 2018-10-01
• Primary completion: 2024-01-23
• Completion: 2024-01-23
• First posted: 2018-10-04
• Last updated: 2024-07-17

Locations

1 site across 1 country: United States