In this study, we aim to define the recommended dose of a VEGFR-TKI (pazopanib) in combination with RT pre-operatively given.
Study design A dose escalation trial of Pazopanib, starting at 400mg daily, orally in combination with the standard 25 x 2Gy preoperative radiotherapy in newly diagnosed extremity sarcoma patients. Dose of pazopanib will be escalated via 600mg to maximally 800mg. Overall treatment time of pazopanib is 40 days. Treatment plan: Pazopanib Dose level Dose of pazopanib orally, once daily, # patients 1. (starting) 400 mg 3 2. 600 mg 3 3. (maximum) 800 mg 3 Treatment plan: radiotherapy RT is given during 5 weeks with a once daily fraction of 2 Gray (50 Gray in 25 daily fractions) RT planning: The dose planning should be performed by CT based Intensity Modulated RT (IMRT) or 3 Dimensional Conformal RT (3D-RT) according to the local planning protocol of the participating institute. Dose specification: According to the ICRU 50/62.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
A dose escalation trial of Pazopanib, starting at 400mg daily, orally in combination with the standard 25 x 2Gy preoperative radiotherapy in newly diagnosed extremity sarcoma patients. Dose of pazopanib will be escalated via 600mg to maximally 800mg. Overall treatment time of pazopanib is 40 days.
The Netherlands Cancer Institute
Amsterdam, North Holland, Netherlands
Dose limiting toxicity
To study the safety and feasibility of adding 6 weeks of orally administered Pazopanib to 25 x 2Gy in 5 weeks preoperative radiotherapy in extremity or head and neck area soft tissue sarcoma patients (to identify the Dose Limiting Toxicity (DLT) and the Recommend Phase II Dose (RPTD) if pazopanib is added to 50 Gy pre-operatively)
Time frame: 14 weeks
the exploration/feasibility of dynamic imaging
The secondary objective is to explore the feasibility to perform perfusion weighted MRI imaging regarding tumor respons to RT and neoangio genesis inhibitor by pazopanib.
Time frame: 14 weeks
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