Adult Soft Tissue SarcomaPhase 2/3NCT02379845
NBTXR3 Crystalline Nanoparticles and Radiation Therapy in Treating Randomized Patients in Two Arms With Soft Tissue Sarcoma of the Extremity and Trunk Wall
A Phase 2/3 study testing NBTXR3 and Radiation therapy in people with Adult Soft Tissue Sarcoma, run by Nanobiotix at 42 sites in 13 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Soft Tissue Sarcoma
- What is being tested?
- NBTXR3 and Radiation therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 42 sitesin 13 countries
- Study dates
- 3 Mar 2015to 20 Sep 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
42 sites in 13 countries.
42 sites in 13 countries
France9 sites
Institut Bergonie
Bordeaux
Centre Leon Berard
Lyon
Institut Paoli Calmettes
Marseille
Centre Regional de Lutte Contre Le Cancer Paul Lamarque
Montpellier
Centre Rene Gauducheau
Nantes, Saint Herblain
Centre Antoine Lacassagne
Nice
Institut Curie
Paris
Institut Claudius Regaud - Oncopole
Toulouse
Institut Gustave Roussy
Villejuif
Romania6 sites
Institutul Oncologic Bucuresti
Bucharest
Spitalului Universitar de Urgenta Militar Central
Bucharest
Amethyst-Cluj
Floreşti
County Hospital 'Dr Gavril Curteanu'
Oradea
County Hospital, Targu Mures
Târgu Mureş
Municipal Emergency Hospital
Timișoara
Philippines4 sites
Perpetual Succour Hospital Cebu
Cebu City
University of Santo Thomas
Manila
The Medical City
Pasig
St. Luke's Medical Center
Quezon City
South Africa4 sites
Iatros International
Bloemfontein
The Oncology Centre
Durban
Gvi Outeniqua Oncology Unit
George
Wilgers Oncology Centre
Pretoria
Spain4 sites
Hospital Universitari Vall D'Hebron
Barcelona
Hospital Clinico Universitario San Carlos
Madrid
START MADRID, Hospital Fundacion Jimenez Diaz
Madrid
START MADRID, Hospital Universitario Madrid Norte Sanchinarro
Madrid
Hungary3 sites
Medical Centre, Hungarian Defence Forces
Budapest
National Institute of Oncology
Budapest
University Pècs
Pécs
Italy3 sites
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
Institute of Oncology Veneto IOV
Padova
Instituto Nazionale Tumori Regina Elena
Rome
Australia2 sites
Capital Region Cancer Service, Canberra Hospital
Canberra
Chris O'Brien Lifehouse
Sydney
About this study
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
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.
Read the 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.
- Conditions
- Adult Soft Tissue Sarcoma
- Being tested
- NBTXR3, Radiation therapy
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBTXR3Device
Also called PEP503
One intratumor implantation by injection
Radiation therapyDevice
5 weeks/50 Gy (5 x 2 Gy by week)
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | NBTXR3 + Radiotherapy Receives: Device: NBTXR3; Device: Radiation therapy |
| Arm B | Active comparator | Radiotherapy alone Receives: Device: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 36 months
Secondary outcomes (6)
Incidence of early and late TEAE, post-TEAE, SAE and laboratory abnormalities (NCI CTCAE V4.0)
Measured: 36 months
Objective Response Rate (ORR) by Imaging (MRI) according to RECIST 1.1
Measured: 36 months
Tumor volume changes (theoretical tumor volume estimated as: Length x Width x Depth
Measured: 36 months
Resection Margins (R0, R1, R2)
Measured: 36 months
Hyalinization, fibrosis, necrosis and tumor infarction percentage
Measured: 36 months
Limb amputation rate
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study start3 Mar 2015
- Primary completion22 May 2018
- Study completion20 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adult Soft Tissue SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanobiotix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PharmaEngine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379845
- Sponsor's protocol ID
- NBTXR3-301
- Status last verified
- Apr 2021
- First submitted
- 19 Feb 2015
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bonvalot S, Rutkowski PL, Thariat J, Carrere S, Ducassou A, Sunyach MP, Agoston P, Hong A, Mervoyer A, Rastrelli M, Moreno V, Li RK, Tiangco B, Herraez AC, Gronchi A, Mangel L, Sy-Ortin T, Hohenberger P, de Baere T, Le Cesne A, Helfre S, Saada-Bouzid E, Borkowska A, Anghel R, Co A, Gebhart M, Kantor G, Montero A, Loong HH, Verges R, Lapeire L, Dema S, Kacso G, Austen L, Moureau-Zabotto L, Servois V, Wardelmann E, Terrier P, Lazar AJ, Bovee JVMG, Le Pechoux C, Papai Z. NBTXR3, a first-in-class radioenhancer hafnium oxide nanoparticle, plus radiotherapy versus radiotherapy alone in patients with locally advanced soft-tissue sarcoma (Act.In.Sarc): a multicentre, phase 2-3, randomised, controlled trial. Lancet Oncol. 2019 Aug;20(8):1148-1159. doi: 10.1016/S1470-2045(19)30326-2. Epub 2019 Jul 8.
PubMed 31296491
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02379845
- Acronym / sponsor ID
- NBTXR3-301
- Conditions
- Adult Soft Tissue Sarcoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- NanobiotixIndustry (pharma, biotech, devices)
- Collaborators
- PharmaEngine
- Study start
- 3 Mar 2015 (actual)
- Primary completion
- 22 May 2018 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Device: NBTXR3, Device: Radiation therapyNBTXR3 + Radiotherapy |
| Arm B | Active comparator | Device: Radiation therapyRadiotherapy alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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 :
- WHO performance score 0 to 2
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NBTXR3Also: PEP503One intratumor implantation by injection | Device | Arm A |
| Radiation therapy5 weeks/50 Gy (5 x 2 Gy by week) | Device | Arm A, Arm B |
Primary outcome
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
6 secondary outcomes
Incidence of early and late TEAE, post-TEAE, SAE and laboratory abnormalities (NCI CTCAE V4.0)
Time frame: 36 months
Objective Response Rate (ORR) by Imaging (MRI) according to RECIST 1.1
Time frame: 36 months
Tumor volume changes (theoretical tumor volume estimated as: Length x Width x Depth
Time frame: 36 months
Resection Margins (R0, R1, R2)
Time frame: 36 months
Hyalinization, fibrosis, necrosis and tumor infarction percentage
Time frame: 36 months
Limb amputation rate
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Derived from this study: PubMed 31296491Bonvalot S, Rutkowski PL, Thariat J, Carrere S, Ducassou A, Sunyach MP, Agoston P, Hong A, Mervoyer A, Rastrelli M, Moreno V, Li RK, Tiangco B, Herraez AC, Gronchi A, Mangel L, Sy-Ortin T, Hohenberger P, de Baere T, Le Cesne A, Helfre S, Saada-Bouzid E, Borkowska A, Anghel R, Co A, Gebhart M, Kantor G, Montero A, Loong HH, Verges R, Lapeire L, Dema S, Kacso G, Austen L, Moureau-Zabotto L, Servois V, Wardelmann E, Terrier P, Lazar AJ, Bovee JVMG, Le Pechoux C, Papai Z. NBTXR3, a first-in-class radioenhancer hafnium oxide nanoparticle, plus radiotherapy versus radiotherapy alone in patients with locally advanced soft-tissue sarcoma (Act.In.Sarc): a multicentre, phase 2-3, randomised, controlled trial. Lancet Oncol. 2019 Aug;20(8):1148-1159. doi: 10.1016/S1470-2045(19)30326-2. Epub 2019 Jul 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
42 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing NBTXR3 and Radiation therapy in people with Adult Soft Tissue Sarcoma, run by Nanobiotix at 42 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in France, Romania, Philippines, South Africa, Spain and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response Rate (pCRR) (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02379845, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.