Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-03-06 @ 9:58 AM
Study NCT ID:
NCT02575066
Status:
TERMINATED
Last Update Posted:
2019-06-27
First Post:
2015-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of Concurrent Pazopanib and Radiotherapy for Non-metastatic Sarcoma Patients
Sponsor:
The Netherlands Cancer Institute
Organization:
Study Overview
Official Title:
Phase II Clinical Study of Concurrent Pazopanib for Non-metastatic Sarcoma Patients to be Treated With Radiotherapy, Localized in the Extremities, Trunk and Chest Wall or the Head and Neck Region (PASART-2)
Status:
TERMINATED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
stopping rule
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PASART-2
Brief Summary:
Radiotherapy (RT) alone is able to induce a clinically significant effect with a variable pathologic response (a pathological complete remission, pCR, defined as ≥ 95%, or ≤ 5% remaining visible tumour cells) in only about 10% of cases. A prior phase I study (PASART-1; NCT01985295) suggested that 25 x 2 Gy preoperative RT in combination with once daily 800mg oral pazopanib is feasible, while inducing tissue replacing tumor that can consist of fibrosis and necrosis in 40% of thus treated patients.
During this study, the interim analysis showed that the combination treatment of preoperative radiation with orally pazopanib is more effective than was anticipated. For this reason, the pazopanib dose of 800 mg once daily is maintained but the RT dose is reduced to 18x2Gy instead of 25x2Gy. Predominant aim of this RT dose reduction is lowering the wound complication risk after preoperative radiotherapy.
During this study, the interim analysis showed that the combination treatment of preoperative radiation with orally pazopanib is more effective than was anticipated. For this reason, the pazopanib dose of 800 mg once daily is maintained but the RT dose is reduced to 18x2Gy instead of 25x2Gy. Predominant aim of this RT dose reduction is lowering the wound complication risk after preoperative radiotherapy.
Detailed Description:
Patients of the first part of the study received radiotherapy (25x2Gy) and pazopanib (QD 800 mg).
Patients of the second part of the study received/ will receive radiotherapy (18x2Gy) and pazopanib (QD 800 mg).
Patients of the second part of the study received/ will receive radiotherapy (18x2Gy) and pazopanib (QD 800 mg).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|---|
| DSSG02 | OTHER | Dutch Sarcoma Study Group | View |