NCT01985295

Combined Modality Treatment of Sarcomas of the Extremities

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sarcoma,Soft Tissue

Interventions

Type	Name	Description
DRUG	pazopanib	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.

Timeline

• Start date: 2010-06-01
• Primary completion: 2014-08-01
• Completion: 2014-11-01
• First posted: 2013-11-15
• Last updated: 2015-10-09

Locations

1 site across 1 country: Netherlands