Spots Global Cancer Trial Database for Combined Modality Treatment of Sarcomas of the Extremities

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Trial Identification

Brief Title: Combined Modality Treatment of Sarcomas of the Extremities

Official Title: Phase I Clinical Study of a Combined Modality Treatment of Sarcomas of the Extremities With Radiotherapy (RT) and Dose-escalation of Pazopanib

Study ID: NCT01985295

Conditions

Sarcoma,Soft Tissue

Interventions

pazopanib

Study Description

Brief Summary: In this study, we aim to define the recommended dose of a VEGFR-TKI (pazopanib) in combination with RT pre-operatively given.

Detailed Description: 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.