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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

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02379845
Recruitment Status : Completed
First Posted : March 5, 2015
Last Update Posted : April 6, 2021
Information provided by (Responsible Party):

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 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 or disease Intervention/treatment Phase
Adult Soft Tissue Sarcoma Device: NBTXR3 Device: Radiation therapy Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized, Open-Label Phase II/III Study, To Compare The Efficacy Of NBTXR3, Implanted As Intratumor Injection And Activated By Radiotherapy, Versus Radiotherapy Alone In Patients With Locally Advanced Soft Tissue Sarcoma Of The Extremity And Trunk Wall
Actual Study Start Date : March 3, 2015
Actual Primary Completion Date : May 22, 2018
Actual Study Completion Date : September 20, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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 :
  1. Incidence of early and late TEAE, post-TEAE, SAE and laboratory abnormalities (NCI CTCAE V4.0) [ Time Frame: 36 months ]
  2. Objective Response Rate (ORR) by Imaging (MRI) according to RECIST 1.1 [ Time Frame: 36 months ]
  3. Tumor volume changes (theoretical tumor volume estimated as: Length x Width x Depth [ Time Frame: 36 months ]
  4. Resection Margins (R0, R1, R2) [ Time Frame: 36 months ]
  5. Hyalinization, fibrosis, necrosis and tumor infarction percentage [ Time Frame: 36 months ]
  6. Limb amputation rate [ Time Frame: 36 months ]

Other Outcome Measures:
  1. Local and distant recurrence rate [ Time Frame: 12 months and 24 months ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age: 18 years and older
  • Locally Advanced Soft Tissue Sarcoma of the Extremity and Trunk Wall
  • All grades
  • Candidate to radiotherapy + surgery (ESMO guideline 2014) i.e. tumor must not have involvement of bone and / or vessel and or nerve :

    • 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
  • Patient with a calculated tumor baseline volume > 3000 mL
  • Metastatic disease (CT-scan / MRI verification) with life expectancy shorter than 6 months
  • Previous radiation therapy in relapse site of soft tissue sarcoma (no radiation re-challenge 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 visits, treatment plans, laboratory tests, and other study procedures
  • Patients participating in another clinical investigation at the time of signature of the informed consent

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

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Sponsors and Collaborators
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nanobiotix
ClinicalTrials.gov Identifier: NCT02379845    
Other Study ID Numbers: NBTXR3-301
First Posted: March 5, 2015    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type