Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-25 @ 3:12 PM
Study NCT ID:
NCT01433068
Status:
COMPLETED
Last Update Posted:
2020-10-06
First Post:
2011-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NBTXR3 Crystalline Nanoparticles and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma of the Extremity
Sponsor:
Nanobiotix
Organization:
Study Overview
Official Title:
An Open-Label, Single Arm, Feasibility And Safety Phase I Study With NBTXR3 Intratumor Implantation (By Injection) And Activated By External Beam Radiation Therapy In Patients With Soft Tissue Sarcoma Of The Extremity And Trunk Wall
Status:
COMPLETED
Status Verified Date:
2020-10
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:
None
Brief Summary:
RATIONALE: Radiation therapy given before surgery of soft tissue sarcoma decreases the size of the tumor mass and the presence of malignant cells in its peripheral region. NBTXR3 and radiation therapy may kill more cancer cells and increase the tumor shrinkage rendering surgery more feasible or easier and achieve better local control of the tumor.
PURPOSE: This Phase I trial aims at evaluating the feasibility of the NBTXR3 injection in the tumor, safety and the adequate dose of NBTXR3 when given with radiation therapy.
PURPOSE: This Phase I trial aims at evaluating the feasibility of the NBTXR3 injection in the tumor, safety and the adequate dose of NBTXR3 when given with radiation therapy.
Detailed Description:
Patients will receive a single intratumor injection of NBTXR3 on day 1 and will receive external beam radiotherapy starting on day 2 up to completion of 5 weeks, 5 days a week of treatment (50Gy, 2Gy/fraction). Then, all patients will undergo surgical resection of the tumor 5 weeks later and will be followed for wound healing and toxicity assessment. A visit of end of treatment will take place approximately 3-4 weeks after surgery. Patients will be followed for evaluation of their disease status and adverse events every 8 weeks until the end of study.
Study Oversight
Has Oversight DMC:
True
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 |
|---|---|---|---|---|
| ID RCB : 2011-A00342-39 | OTHER | Afssaps | View |