Clinical Trials

Clinical Trials

i-SAbR Trials

Phase II Trial of High-Dose IL-2 and Stereotactic Ablative Radiation Therapy (SAbR) for Patients with Metastatic Clear Cell Renal Cell Cancer
Treatment: Stereotactic radiation to multiple metastatic lesions followed by HD IL-2.
Endpoints: Response rate, partial response, complete response, overall survival.
Eligibility: Clear cell histology of renal cancer, metastatic disease, ECOG 0-1.
Website: https://www.clinicaltrials.gov/ct2/show/NCT01896271
Research coordinator: Samantha Mannala, Samantha.Mannala@UTSouthwestern.edu
Closed to accrual

Phase II Trial of Nivolumab and Stereotactic Ablative Radiation Therapy (SAbR) for Patients with Metastatic Clear Cell Renal Cell Cancer
Treatment: SAbR of multiple metastatic lesions in 1 or 3 fractions concurrent with Nivolumab.
Endpoints: Response rate.
Eligibility: Progression or not able to tolerate targeted therapy.
Website: https://clinicaltrials.gov/ct2/show/NCT02781506
Research coordinator: Satish Veerla, Satish.Veerla@UTSouthwestern.eduClosed to accrual

Phase II Trial of Sipuleucel-T and Stereotactic Ablative Body Radiation (SAbR) for Patients with Metastatic Castrate-Resistant Prostate Cancer (mCRPC)
Treatment: Stereotactic radiation to multiple metastatic lesions concurrently with Sipuleucel-T.
Endpoints: Time to progression, biochemical recurrence-free survival, overall survival.
Eligibility: Metastatic prostate cancer, castrate-resistant disease.
Website: https://www.clinicaltrials.gov/ct2/show/NCT01818986
Research coordinator: Satish Veerla, Satish.Veerla@UTSouthwestern.edu
Closed to accrual

Other SBRT Trials

Phase II Trial of Stereotactic Ablative Radiation Therapy (SAbR) for Patients with Primary Renal Cell Cancer
Treatment: Stereotactic radiation of primary renal cancer with 3 or 5 fractions over two weeks.
Endpoint: Local control.
Eligibility: Growing renal mass.
Website: https://www.clinicaltrials.gov/ct2/show/NCT02141919
Research coordinator: Satish Veerla, Satish.Veerla@UTSouthwestern.edu

Phase II Trial of Neoadjuvant Stereotactic Ablative Radiation Therapy (SAbR) to IVC Tumor Thrombus for Patients with Newly Diagnosed Renal Cell Cancer
Treatment: Stereotactic radiation of IVC tumor thrombus ≥ level II followed by tumor thrombectomy and nephrectomy.
Endpoints: Relapse-free survival at 1 year.
Eligibility: ≥ level II IVC tumor thrombus with primary renal cancer.
Website: https://www.clinicaltrials.gov/ct2/show/NCT02473536
Research coordinator: Satish Veerla, Satish.Veerla@UTSouthwestern.edu

Phase II Trial of SAbR for Patients with Oligometastatic Renal Cell Carcinoma)

Treatment: SAbR dose and fractionations to targeted lesions with 1, 3, or 5 fractions.
Endpoints: Primary endpoint will be time to start of systemic therapy (TTST). Secondary endpoints include modified progression-free survival (mPFS), progression-free survival on systemic therapy started after SAbR (PFS-ST), health-related quality of life (HR-QoL), overall survival, cancer-specific survival, local control, interval time to development of new lesions that can be treated with additional local therapy, and toxicity profile from SAbR.
Eligibility: Metastatic renal cell carcinoma with limited measurable extracranial metastases (limited metastases, or oligometastases, defined as ≤3 sites of metastasis).
Website: https://clinicaltrials.gov/ct2/show/NCT02956798
Research coordinator: Satish Veerla, Satish.Veerla@UTSouthwestern.edu

A Phase II Trial of Stereotactic Ablative Radiation Therapy (SAbR) for Patients with Oligo-Progressive Renal Cancer (RCC)
Treatment: Adjuvant stereotactic radiation therapy to oligo-progressive sites of renal cancer while being treated with systemic therapy.
Endpoints: Time to progression/change of systemic therapy.
Eligibility: On systemic therapy with radiographic scan to verify oligo-progression ≤3 sites AND ≤ 30% of all sites, diagnosis of metastatic renal cell carcinoma.
Website: https://clinicaltrials.gov/ct2/show/NCT03696277
Research coordinator: Samantha Mannala, Samantha.Mannala@UTSouthwestern.edu

Phase II Study of Stereotactic Body Radiotherapy (SBRT) for High-Risk Prostate Cancer with Injectable Rectal Spacer
Treatment: 9.5Gy x 5 to prostate and SV and 4.5Gy x5 to pelvic lymph node regions after placement of fiducial and bio-degradable rectal spacer.
Endpoints: Acute GI toxicity.
Eligibility: Gleason >7 OR PSA >20 OR cT3.  
Comments: Neo-adjuvant and concurrent long-term ADT.
Website: https://www.clinicaltrials.gov/ct2/show/NCT02353819
Research coordinator: Samantha Mannala, Samantha.Mannala@UTSouthwestern.edu

For information on these trials, please contact the respective research coordinator.