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NBTXR3 Crystalline Nanoparticles and Radiation Therapy in Treating Randomized Patients in Two Arms With Soft Tissue Sarcoma of the Extremity and Trunk Wall

NCT02379845 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2021-04-06

No results posted yet for this study

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 II/III is a prospective randomized, multi-center, open-label and active controlled two arms study in patients with locally advanced soft tissue sarcoma (STS) of the extremity and trunk wall. Patients will be randomized to receive either NBTXR3 as intratumor injection, activated by external beam radiation therapy or external beam radiation therapy alone, as preoperative treatment. Once the radiotherapy treatment is completed, tumor surgery will be performed in all patients.

Conditions

  • Adult Soft Tissue Sarcoma

Interventions

DEVICE

NBTXR3

One intratumor implantation by injection

DEVICE

Radiation therapy

5 weeks/50 Gy (5 x 2 Gy by week)

Sponsors & Collaborators

  • PharmaEngine

    collaborator INDUSTRY

  • Nanobiotix

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-03
Primary Completion
2018-05-22
Completion
2020-09-20

Countries

  • Australia
  • Belgium
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Italy
  • Norway
  • Philippines
  • Poland
  • Romania
  • South Africa
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02379845 on ClinicalTrials.gov