Sarcoma,Soft Tissue Clinical Trial
Official title:
Phase I Clinical Study of a Combined Modality Treatment of Sarcomas of the Extremities With Radiotherapy (RT) and Dose-escalation of Pazopanib
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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