Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT01985295
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2013-10-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Modality Treatment of Sarcomas of the Extremities
Sponsor:
The Netherlands Cancer Institute
Organization:
Study Overview
Official Title:
Phase I Clinical Study of a Combined Modality Treatment of Sarcomas of the Extremities With Radiotherapy (RT) and Dose-escalation of Pazopanib
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PASART-1
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2009-014901-15 | EUDRACT_NUMBER | None | View |