Working... 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

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. Identifier: NCT02379845
Recruitment Status : Active, not recruiting
First Posted : March 5, 2015
Last Update Posted : June 4, 2018
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : April 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: Lenght x Width x Depth [ Time Frame: 36 months ]
  4. Resection Margins (R0, R1, R2) [ Time Frame: 36 months ]
  5. 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

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.

Layout table for eligibility information
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 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

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 identifier (NCT number): NCT02379845

  Hide Study Locations
Layout table for location information
Capital Region Cancer Service, Canberra Hospital
Canberra, Australia
Chris O'Brien Lifehouse
Sydney, Australia
Jules Bordet Institute
Bruxelles, Belgium
Ghent University Hospital
Ghent, Belgium
Centre Rene Gauducheau
Nantes, Saint Herblain, France
Institut Bergonie
Bordeaux, France
Centre Leon Berard
Lyon, France
Institut Paoli Calmettes
Marseille, France
Centre Regional de Lutte Contre Le Cancer Paul Lamarque
Montpellier, France
Centre Antoine Lacassagne
Nice, France
Institut Curie
Paris, France
Institut Claudius Regaud - Oncopole
Toulouse, France
Institut Gustave Roussy
Villejuif, France
Klinikum Mannheim
Mannheim, Germany
Klinikum Nürnberg
Nürnberg, Germany
Hong Kong
Princes of Wales Hospital
Shatin, Hong Kong
Medical Centre, Hungarian Defence Forces
Budapest, Hungary
National Institute of Oncology
Budapest, Hungary
University Pècs
Pecs, Hungary
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Institute of Oncology Veneto IOV
Padova, Italy
Instituto Nazionale Tumori Regina Elena
Rome, Italy
Oslo University Hospital
Oslo, Norway
Perpetual Succour Hospital Cebu
Cebu City, Philippines
University of Santo Thomas
Manila, Philippines
The Medical City
Pasig City, Philippines
St. Luke's Medical Center
Quezon City, Philippines
Cancer Center Institute
Warsaw, Poland
Institutul Oncologic Bucuresti
Bucharest, Romania
Spitalului Universitar de Urgenta Militar Central
Bucharest, Romania
Floresti, Romania
County Hospital 'Dr Gavril Curteanu'
Oradea, Romania
County Hospital, Targu Mures
Targu Mures, Romania
Municipal Emergency Hospital
Timisoara, Romania
South Africa
Iatros International
Bloemfontein, South Africa
The Oncology Centre
Durban, South Africa
Gvi Outeniqua Oncology Unit
George, South Africa
Wilgers Oncology Centre
Pretoria, South Africa
Hospital Universitari Vall D'Hebron
Barcelona, Spain
Hospital Clinico Universitario San Carlos
Madrid, Spain
START MADRID, Hospital Fundacion Jimenez Diaz
Madrid, Spain
START MADRID, Hospital Universitario Madrid Norte Sanchinarro
Madrid, Spain
Sponsors and Collaborators