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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 April 2021
• Main ID: NCT02379845
• Date of registration: 19/02/2015
• Prospective Registration: Yes
• Primary sponsor: Nanobiotix
• Public title: NBTXR3 Crystalline Nanoparticles and Radiation Therapy in Treating Randomized Patients in Two Arms With Soft Tissue Sarcoma of the Extremity and Trunk Wall
• Scientific 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
• Date of first enrolment: March 3, 2015
• Target sample size: 180
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02379845
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2/Phase 3

Countries of recruitment

Australia, Belgium, Canada, France, Germany, Hong Kong, Hungary, Italy, Netherlands, Norway, Philippines, Poland, Romania, South Africa, Spain

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Adult Soft Tissue Sarcoma

Intervention(s)

Device: NBTXR3

Device: Radiation therapy

Primary Outcome(s)

Pathological Complete Response Rate (pCRR) [Time Frame: 36 months]

Secondary Outcome(s)

Limb amputation rate [Time Frame: 36 months]

Objective Response Rate (ORR) by Imaging (MRI) according to RECIST 1.1 [Time Frame: 36 months]

Resection Margins (R0, R1, R2) [Time Frame: 36 months]

Incidence of early and late TEAE, post-TEAE, SAE and laboratory abnormalities (NCI CTCAE V4.0) [Time Frame: 36 months]

Tumor volume changes (theoretical tumor volume estimated as: Length x Width x Depth [Time Frame: 36 months]

Hyalinization, fibrosis, necrosis and tumor infarction percentage [Time Frame: 36 months]

Secondary ID(s)

NBTXR3-301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PharmaEngine