Renal Cell Carcinoma Clinical Trial
Official title:
Phase I/II Trial Evaluating Toxicity and Efficacy of Adding Stereotactic Body Radiotherapy to Sorafenib in Patients With Metastatic, Recurrent, or Unresectable Renal Cell Cancer
The purpose of this study is to determine the safety and efficacy of combined stereotactic body radiotherapy (SBRT) + sorafenib in the treatment of patients with Stage IV renal cell carcinoma (RCC) who have recurred locally, developed progression of an unresectable primary or progression of extra-cranial and/or extra-pulmonary metastases while on sorafenib. All subjects will remain on sorafenib during SBRT.
In the phase I portion of this investigation, subjects will be enrolled in cohorts of three
to the SBRT dose groups. Subjects will remain on sorafenib therapy during SBRT. Any change
in sorafenib dosage before, during or after SBRT will be at the discretion of the subject's
medical oncologist. Subjects will be assessed during, immediately after and at 4 and 8 weeks
post-therapy for toxicity.
Stereotactic body radiotherapy will be given in increasingly higher dose levels each cohort
until the maximum tolerated dose of radiation is determined.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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