NBTXR3 Crystalline Nanoparticles and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma of the Extremity
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Evaluation of the feasibility of the intratumor injection of NBTXR3 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]- To evaluate the feasibility of NBTXR3 given as intratumor implantation (by injection) and activated by external beam radiation in patients with soft tissue sarcoma of the extremity and trunk wall
- Assessment of the safety profile and determination of early dose limiting toxicity [ Time Frame: 20 months ] [ Designated as safety issue: Yes ]- To assess the safety profile and determine the early dose limiting toxicity (DLT) of NBTXR3 intratumor implantation (by injection) and activated by external beam radiation
- Evaluation of the anti-tumor activity of NBTXR3 in terms of pathological Response (pR) [ Time Frame: 20 months ] [ Designated as safety issue: No ]- To evaluate the anti-tumor activity of NBTXR3 implanted within the tumor (by injection) at Day 1 and activated 24 hours later by external beam radiation therapy in terms of pathological Response (pR)
- Evaluation of the Response Rate (RR) of NBTXR3 as per RECIST [ Time Frame: 20 months ] [ Designated as safety issue: No ]- To evaluate the Response Rate (RR) of NBTXR3 implanted within the tumor (by injection) at Day 1 and activated 24 hours later by external beam radiation therapy as per RECIST
- Characterization of the body kinetic profile of NBTXR3 [ Time Frame: 20 months ] [ Designated as safety issue: Yes ]- To characterize the body kinetic profile of NBTXR3 implanted within the tumor (by injection) at Day 1 and Day 2 before its activation by radiation therapy
|Study Start Date:||October 2011|
|Study Completion Date:||February 2015|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
One intratumor implantation by injection
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433068
|Bordeaux, France, 33076|
|Institut Gustave Roussy|
|Villejuif, France, 94805|
|Principal Investigator:||Sylvie BONVALOT, MD-PhD||Head of Surgery Division|
|Principal Investigator:||Guy KANTOR, MD-PhD||Head of Radiotherapy Department|