We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified April 2017 by Nanobiotix
Sponsor:
ClinicalTrials.gov Identifier:
NCT02379845
First Posted: March 5, 2015
Last Update Posted: April 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
PharmaEngine
Information provided by (Responsible Party):
Nanobiotix
  Purpose

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.


Condition Intervention Phase
Adult Soft Tissue Sarcoma Device: NBTXR3 Device: Radiation therapy Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MULTICENTER RANDOMIZED, OPEN-LABEL PHASE II/III STUDY, TO COMPARE EFFICACY OF NBTXR3 IMPLANTED AS INTRATUMOR INJECTION AND ACTIVATED BY RADIOTHERAPY, VERSUS RADIOTHERAPY ALONE IN PATIENTS WITH LOCALLY ADVANCED SOFT TISSUE SARCOMA (EXTREMITY AND TRUNK WALL)

Resource links provided by NLM:


Further study details as provided by Nanobiotix:

Primary Outcome Measures:
  • Pathological Complete Response Rate (pCRR) [ Time Frame: 36 months ]
    To compare antitumor activity in terms of Pathological complete response rate (pCRR) of intratumor injection of NBTXR3 activated by external beam radiation therapy (EBRT), versus EBRT alone


Secondary Outcome Measures:
  • Incidence of early and late TEAE, post-TEAE, SAE and laboratory abnormalities (NCI CTCAE V4.0) [ Time Frame: 30 months ]
  • Objective Response Rate (ORR) by Imaging (MRI) according to RECIST 1.1 [ Time Frame: 30 months ]
  • Tumor volume changes (theoretical tumor volume estimated as: Lenght x Width x Depth [ Time Frame: 30 months ]
  • Resection Margins (R0, R1, R2) [ Time Frame: 30 months ]
  • Limb amputation rate [ Time Frame: 36 months ]

Estimated Enrollment: 180
Study Start Date: February 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
NBTXR3 + Radiotherapy
Device: NBTXR3
One intratumor implantation by injection
Other Name: PEP503
Device: Radiation therapy
5 weeks/50 Gy (5 x 2 Gy by week)
Active Comparator: Arm B
Radiotherapy alone
Device: Radiation therapy
5 weeks/50 Gy (5 x 2 Gy by week)

Detailed Description:
Patients who will be allocated in arm A, will receive a single intratumor injection of NBTXR3 and will receive external beam radiotherapy starting 24hrs after the injection 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 event until the end of study.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18 years and older
  • Locally Advanced Soft Tissue Sarcoma of the Extremity and Trunk Wall
  • All grades, including Locally advanced unresectable low grade tumor
  • Candidate to radiotherapy i.e. unresectable tumor or unfeasible carcinological surgery:

    • Primary tumor or,
    • Relapsed tumor, localized out of previously irradiated area
  • WHO performance score 0 to 2
  • Adequate function of bone marrow
  • Adequate renal function
  • Adequate hepatic function
  • Adequate pulmonary function
  • All female patients of childbearing potential must have a negative serum/urinary pregnancy test

Exclusion Criteria:

  • Absence of written Informed Consent duly signed and dated
  • Patients with the following histological type: embryonal or alveolar rhabdomyosarcoma, Ewing's sarcoma, osteosarcoma or chondrosarcoma, Kaposi's sarcoma, primitive neuroectodermal tumor, angiosarcoma, aggressive fibromatosis or dermatofibrosarcoma protuberans
  • Soft Tissue Sarcoma of the Trunk Wall localized in the abdominal region i.e. the region defined cranially by the xiphoid process of the sternum and the costal margins, and caudally by the line joining the anterior superior iliac spines, both limited by the perpendicular lines crossing both nipples
  • Metastatic disease (CT-scan / MRI verification) with life expextancy shorter than 6 months
  • Previous radiation therapy in relapse site of soft tissue sarcoma (no radiation re-chanllenge is permitted)
  • Concurrent treatment with any other anticancer therapy, including chemotherapy, immunotherapy, targeted therapy, gene therapy, or patients planning to receive these treatments during the study
  • Absence of histologically or cytologically proven cancer at the first diagnosis
  • Previous neoadjuvant chemotherapy treatment given as an upfront of the current treatment line
  • Hemolytic anemia
  • Autoimmune disease
  • Complete initial work up earlier than 4 weeks prior to patient registration
  • Patients unable to comply with scheduled visites, treatment plans, laboratory tests, and other study procedures
  • Patients participating in another clinical investigation at the time of signature of the informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02379845


Contacts
Contact: Mikaela DIMITRIU, PhD mikaela.dimitriu@nanobiotix.com
Contact: Elsa BORGHI, MD elsa.borghi@nanobiotix.com

  Show 39 Study Locations
Sponsors and Collaborators
Nanobiotix
PharmaEngine
  More Information

Responsible Party: Nanobiotix
ClinicalTrials.gov Identifier: NCT02379845     History of Changes
Other Study ID Numbers: NBTXR3-301
First Submitted: February 19, 2015
First Posted: March 5, 2015
Last Update Posted: April 25, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms