Clinical Study of Concurrent Pazopanib and Radiotherapy for Non-metastatic Sarcoma Patients
Status:
Terminated
Trial end date:
2019-03-20
Target enrollment:
Participant gender:
Summary
Radiotherapy (RT) alone is able to induce a clinically significant effect with a variable
pathologic response (a pathological complete remission, pCR, defined as ≥ 95%, or ≤ 5%
remaining visible tumour cells) in only about 10% of cases. A prior phase I study (PASART-1;
NCT01985295) suggested that 25 x 2 Gy preoperative RT in combination with once daily 800mg
oral pazopanib is feasible, while inducing tissue replacing tumor that can consist of
fibrosis and necrosis in 40% of thus treated patients.
During this study, the interim analysis showed that the combination treatment of preoperative
radiation with orally pazopanib is more effective than was anticipated. For this reason, the
pazopanib dose of 800 mg once daily is maintained but the RT dose is reduced to 18x2Gy
instead of 25x2Gy. Predominant aim of this RT dose reduction is lowering the wound
complication risk after preoperative radiotherapy.