NCT04974671

Trial Of Stereotactic Body Radiation Therapy (SBRT) for Oligoprogression on Immune Checkpoint Inhibitors (ICI) in Metastatic Renal Cell Carcinoma

Phase II Trial Of Stereotactic Body Radiation Therapy (SBRT) for Oligoprogression on Immune Checkpoint Inhibitors (ICI) in Metastatic Renal Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 delivered on nonconsecutive days (if \>1 fraction) for a total of 1-5 fractions depending on anatomic site at the treating physicians discretion. Treatment to multiple sites can be delivered sequentially or concurrently, at the treating physicians discretion. Patients will undergo response-assessment imaging (CT chest/abdomen/pelvis with IV contrast and/or PET CT scan and/or MRI plus or minus contrast), and response to treatment will be measured via RECIST. The acute and long-term toxicity will be monitored and graded per CTCAE 5.0 (https://ctep.cancer.gov/). Patients will continue on the same immune checkpoint inhibitor-containing regimen during Stereotactic Body Radiation Therapy planning and delivery, and after completion of Stereotactic Body Radiation Therapy until progression of disease as defined by RECIST criteria. The immune checkpoint inhibitor-containing regimen can be continued beyond RECIST progression of disease if the treating physician feels that a patient will continue to benefit. Each eligible patient will be discussed at a multidisciplinary tumor board in the presence of medical and radiation oncology and will be seen in consultation in a Yale-affiliated radiation oncology department prior to enrollment in the trial.

Conditions

• Renal Cell Carcinoma
• Metastatic Renal Cell Carcinoma
• Oligoprogressive
• Progression

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiation Therapy	1-5 fraction Stereotactic Body Radiation Therapy to all sites of progression

Timeline

• Start date: 2023-12-22
• Primary completion: 2027-01-01
• Completion: 2028-04-01
• First posted: 2021-07-23
• Last updated: 2025-12-04

Locations

1 site across 1 country: United States