This randomized controlled phase II trial will investigate whether the addition of stereotactic body radiotherapy to checkpoint inhibitor treatment in patients with non-small-cell lung carcinoma, urothelial carcinoma, renal cell carcinoma, melanoma or head-and-neck carcinoma can improve progression-free survival as compared to checkpoint inhibitor monotherapy. The primary outcome is progression-free survival; secondary outcomes include overall survival, response according to iRecist and Recist v1.1 and toxicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
99
per national standard of care
Stereotactic body radiotherapy is administered to maximally 3 lesions in 3 fractions of 8Gy prior to the second/third cycle of checkpoint inhibitors.
AZ Sint-Lucas
Ghent, Oost-Vlaanderen, Belgium
AZ Sint-Lucas
Bruges, West-Vlaanderen, Belgium
GasthuisZusters Antwerpen
Antwerp, Belgium
Jules Bordet Institute
Brussels, Belgium
University Hospital Ghent
Ghent, Belgium
Progression-free survival
Progression-free survival will be defined as the time from randomization to disease progression (as per iRECIST) or death from any cause.
Time frame: 15 months
Overall survival
Overall survival will be defined as the time from randomization to death from any cause.
Time frame: 2 years after start trial treatment
Tumor response as per RECIST
Response of non-irradiated lesions will be evaluated as per RECIST v1.1.
Time frame: 12 weeks
Tumor response as per iRECIST
Response of non-irradiated lesions will be evaluated as per iRECIST
Time frame: 12 weeks
Incidence of Treatment-Related Adverse Events [safety and tolerability]
Adverse events will be monitored as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 12 weeks
Patient-reported quality of life
Quality of life will be assessed as per EORTC-QLQ C30 questionnaire
Time frame: 12 weeks
Systemic immune response
Exploratory translational analyses will be performed using blood and fecal samples
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.