Phase II Trial Of Stereotactic Body Radiation Therapy (SBRT) for Oligoprogression on Immune Checkpoint Inhibitors (ICI) in Metastatic Renal Cell Carcinoma
Yale University
Summary
This Phase II trial will evaluate progression-free survival after Stereotactic Body Radiation Therapy to oligoprogressive (1-5) lesions in metastatic renal cell carcinoma patients on any immune checkpoint inhibitor-containing regimen with last dose of systemic therapy within 3 months prior to trial enrollment.
Description
This Phase II trial will evaluate progression-free survival after Stereotactic Body Radiation Therapy to oligoprogressive (1-5) lesions in metastatic renal cell carcinoma patients on any immune checkpoint inhibitor-containing regimen with last dose of systemic therapy within 3 months prior to trial enrollment. Alternative local therapy (including but not limited to metastectomy or radiofrequency ablation) to one or more of the oligoprogressive lesions is allowed provided at least one of the lesions is receiving Stereotactic Body Radiation Therapy. Stereotactic Body Radiation Therapy will be de…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: In order to be eligible for participation in this trial, the subject must: 1. Be willing and able to provide written informed consent/assent for the trial 2. Be ≥ 18 years of age on day of signing informed consent. 3. Have histologically confirmed renal cell carcinoma with metastatic disease detected on imaging. Biopsy of metastasis is preferred but not required 4. The subject has a performance status of 0, 1, or 2 on the ECOG Performance Scale 5. The life expectancy is \> 6 months 6. The most recent systemic therapy must be an ICI-containing regimen, delivered for at lea…
Interventions
- RadiationStereotactic Body Radiation Therapy
1-5 fraction Stereotactic Body Radiation Therapy to all sites of progression
Location
- Yale UniversityNew Haven, Connecticut