Phase I/II Trial of Stereotactic Body Radiotherapy With Concurrent Fixed Dose Tyrosine Kinase Inhibitors in Metastatic Renal Cell Carcinoma: Dose Limiting Toxicity and Abscopal Effect.

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

Conditions
Carcinoma, Renal Cell
Interventions
RADIATION

Stereotactic body radiotherapy

A first line TKI will be administered according to the standard dosing of the drug for metastatic RCC during a 1-week run-in period after which SBRT will be delivered to the largest metastatic lesion concurrently with the TKI. The SBRT dose will be escalated in 3 dose levels, starting at 24Gy (8 Gy per fraction), followed by 30 Gy (10 Gy per fraction) and 36 Gy (12 Gy per fraction).

Trial Locations (1)

9000

Dept. of Radiotherapy, Ghent University Hospital, Ghent

All Listed Sponsors
lead

University Hospital, Ghent

OTHER

NCT02334709 - Phase I/II Trial of Stereotactic Body Radiotherapy With Concurrent Fixed Dose Tyrosine Kinase Inhibitors in Metastatic Renal Cell Carcinoma: Dose Limiting Toxicity and Abscopal Effect. | Biotech Hunter | Biotech Hunter