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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02379845




Registration number
NCT02379845
Ethics application status
Date submitted
19/02/2015
Date registered
5/03/2015
Date last updated
4/06/2018

Titles & IDs
Public title
NBTXR3 Crystalline Nanoparticles and Radiation Therapy in Treating and Randomized Patients in Two Arms With Soft Tissue Sarcoma of the Extremity and Trunk Wall
Scientific 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)
Secondary ID [1] 0 0
NBTXR3-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adult Soft Tissue Sarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - NBTXR3
Treatment: Devices - Radiation therapy

Experimental: Arm A - NBTXR3 + Radiotherapy

Active Comparator: Arm B - Radiotherapy alone


Treatment: Devices: NBTXR3
One intratumor implantation by injection

Treatment: Devices: Radiation therapy
5 weeks/50 Gy (5 x 2 Gy by week)

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pathological Complete Response Rate (pCRR) - 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
Timepoint [1] 0 0
36 months
Secondary outcome [1] 0 0
Incidence of early and late TEAE, post-TEAE, SAE and laboratory abnormalities (NCI CTCAE V4.0)
Timepoint [1] 0 0
36 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR) by Imaging (MRI) according to RECIST 1.1
Timepoint [2] 0 0
36 months
Secondary outcome [3] 0 0
Tumor volume changes (theoretical tumor volume estimated as: Lenght x Width x Depth
Timepoint [3] 0 0
36 months
Secondary outcome [4] 0 0
Resection Margins (R0, R1, R2)
Timepoint [4] 0 0
36 months
Secondary outcome [5] 0 0
Limb amputation rate
Timepoint [5] 0 0
36 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Capital Region Cancer Service, Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse - Sydney
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Bruxelles
Country [2] 0 0
Belgium
State/province [2] 0 0
Ghent
Country [3] 0 0
France
State/province [3] 0 0
Saint Herblain
Country [4] 0 0
France
State/province [4] 0 0
Bordeaux
Country [5] 0 0
France
State/province [5] 0 0
Lyon
Country [6] 0 0
France
State/province [6] 0 0
Marseille
Country [7] 0 0
France
State/province [7] 0 0
Montpellier
Country [8] 0 0
France
State/province [8] 0 0
Nice
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
France
State/province [10] 0 0
Toulouse
Country [11] 0 0
France
State/province [11] 0 0
Villejuif
Country [12] 0 0
Germany
State/province [12] 0 0
Mannheim
Country [13] 0 0
Germany
State/province [13] 0 0
Nürnberg
Country [14] 0 0
Hong Kong
State/province [14] 0 0
Shatin
Country [15] 0 0
Hungary
State/province [15] 0 0
Budapest
Country [16] 0 0
Hungary
State/province [16] 0 0
Pecs
Country [17] 0 0
Italy
State/province [17] 0 0
Milan
Country [18] 0 0
Italy
State/province [18] 0 0
Padova
Country [19] 0 0
Italy
State/province [19] 0 0
Rome
Country [20] 0 0
Norway
State/province [20] 0 0
Oslo
Country [21] 0 0
Philippines
State/province [21] 0 0
Cebu City
Country [22] 0 0
Philippines
State/province [22] 0 0
Manila
Country [23] 0 0
Philippines
State/province [23] 0 0
Pasig City
Country [24] 0 0
Philippines
State/province [24] 0 0
Quezon City
Country [25] 0 0
Poland
State/province [25] 0 0
Warsaw
Country [26] 0 0
Romania
State/province [26] 0 0
Bucharest
Country [27] 0 0
Romania
State/province [27] 0 0
Floresti
Country [28] 0 0
Romania
State/province [28] 0 0
Oradea
Country [29] 0 0
Romania
State/province [29] 0 0
Targu Mures
Country [30] 0 0
Romania
State/province [30] 0 0
Timisoara
Country [31] 0 0
South Africa
State/province [31] 0 0
Bloemfontein
Country [32] 0 0
South Africa
State/province [32] 0 0
Durban
Country [33] 0 0
South Africa
State/province [33] 0 0
George
Country [34] 0 0
South Africa
State/province [34] 0 0
Pretoria
Country [35] 0 0
Spain
State/province [35] 0 0
Barcelona
Country [36] 0 0
Spain
State/province [36] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Nanobiotix
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
PharmaEngine
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02379845
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02379845