Adult Soft Tissue SarcomaPhase 1NCT01433068
NBTXR3 Crystalline Nanoparticles and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma of the Extremity
A Phase 1 study testing NBTXR3 in people with Adult Soft Tissue Sarcoma, run by Nanobiotix at 2 sites in France.
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
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2011to Feb 2015
- Phase
- Phase 1
- 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
- Soft tissue sarcoma of the extremity or trunk wall, or localized in the posterior region of the neck (i.e., coronal section passing through the posterior limit of the ear)
- Locally advanced soft tissue sarcoma,candidate to radiotherapy
- Primary tumor or,
- Relapsed tumor, localized out of already irradiated area or,
- Sarcomas secondary to previous irradiation exposure due to other primary cancer
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- WHO performance score 0 to 2
- Adequate function of Bone marrow:
- Adequate renal function
- Adequate liver function
- All female patients of childbearing potential must have a negative serum/urinary pregnancy test
Who cannot join
- Written Informed Consent not obtained, signed and dated
- Patients with the following histological type: Gastrointestinal Stromal Tumors (GIST), embryonal or alveolar rhabdomyosarcoma, Ewing's sarcoma, osteosarcoma or chondrosarcoma, Kaposi's sarcoma, primitive neuroectodermal tumor 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
- Angiosarcoma of the trunk wall because of its diffuse frontier
- Metastatic disease (CT-scan verification) with survival expectation < 6 months
- Concurrent treatment with any other anticancer therapy
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- Absence of histologically or cytologically proven cancer at the first diagnosis
- Previous neoadjuvant chemotherapy treatment given as an upfront of the current treatment line
- Previous radiation therapy in relapse site of the soft tissue sarcoma (no radiation re-challenge is permitted)
- Moderate and severe liver dysfunction
- 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
2 sites in 1 country.
France2 sites
Institut Bergonie
Bordeaux, 33076
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: An Open-Label, Single Arm, Feasibility And Safety Phase I Study With NBTXR3 Intratumor Implantation (By Injection) And Activated By External Beam Radiation Therapy In Patients With 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 I trial aims at evaluating the feasibility of the NBTXR3 injection in the tumor, safety and the adequate dose of NBTXR3 when given with radiation therapy.
Read the detailed description
Patients will receive a single intratumor injection of NBTXR3 on day 1 and will receive external beam radiotherapy starting on day 2 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 events every 8 weeks until the end of study.
- Conditions
- Adult Soft Tissue Sarcoma
- Being tested
- NBTXR3
- Keywords
- Adult Soft Tissue Sarcoma of the extremities and Trunk wall
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBTXR3Device
One intratumor implantation by injection
| Study group | Role | What they receive |
|---|---|---|
| NBTXR3 | Experimental | Not described Receives: Device: NBTXR3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the feasibility of the intratumor injection of NBTXR3
- To evaluate the feasibility of NBTXR3 given as intratumor implantation (by injection) and activated by external beam radiation in patients with soft tissue sarcoma of the extremity and trunk wall
Measured: 6 months
Assessment of the safety profile and determination of early dose limiting toxicity
- To assess the safety profile and determine the early dose limiting toxicity (DLT) of NBTXR3 intratumor implantation (by injection) and activated by external beam radiation
Measured: 20 months
Secondary outcomes (3)
Evaluation of the anti-tumor activity of NBTXR3 in terms of pathological Response (pR)
- To evaluate the anti-tumor activity of NBTXR3 implanted within the tumor (by injection) at Day 1 and activated 24 hours later by external beam radiation therapy in terms of pathological Response (pR)
Measured: 20 months
Evaluation of the Response Rate (RR) of NBTXR3 as per RECIST
- To evaluate the Response Rate (RR) of NBTXR3 implanted within the tumor (by injection) at Day 1 and activated 24 hours later by external beam radiation therapy as per RECIST
Measured: 20 months
Characterization of the body kinetic profile of NBTXR3
- To characterize the body kinetic profile of NBTXR3 implanted within the tumor (by injection) at Day 1 and Day 2 before its activation by radiation therapy
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanobiotix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sylvie BONVALOT, MD-PhD, Principal investigator, Head of Surgery DivisionGuy KANTOR, MD-PhD, Principal investigator, Head of Radiotherapy Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433068
- Sponsor's protocol ID
- NBTXR3-101
- Other IDs
- ID RCB : 2011-A00342-39
- Status last verified
- Oct 2020
- First submitted
- 9 Sep 2011
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single Arm, Feasibility And Safety Phase I Study With NBTXR3 Intratumor Implantation (By Injection) And Activated By External Beam Radiation Therapy In Patients With Soft Tissue Sarcoma Of The Extremity And Trunk Wall
- ClinicalTrials.gov ID
- NCT01433068
- Acronym / sponsor ID
- NBTXR3-101
- Conditions
- Adult Soft Tissue Sarcoma
- Keywords
- Adult Soft Tissue Sarcoma of the extremities and Trunk wall
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- NanobiotixIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 13 Sep 2011 (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 I trial aims at evaluating the feasibility of the NBTXR3 injection in the tumor, safety and the adequate dose of NBTXR3 when given with radiation therapy.
Detailed description
Patients will receive a single intratumor injection of NBTXR3 on day 1 and will receive external beam radiotherapy starting on day 2 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 events every 8 weeks until the end of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NBTXR3 | Experimental | Device: NBTXR3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age: 18 years and older
- Soft tissue sarcoma of the extremity or trunk wall, or localized in the posterior region of the neck (i.e., coronal section passing through the posterior limit of the ear)
- Locally advanced soft tissue sarcoma,candidate to radiotherapy
- WHO performance score 0 to 2
- Adequate function of Bone marrow:
Key exclusion criteria (15 listed)
- Written Informed Consent not obtained, signed and dated
- Patients with the following histological type: Gastrointestinal Stromal Tumors (GIST), embryonal or alveolar rhabdomyosarcoma, Ewing's sarcoma, osteosarcoma or chondrosarcoma, Kaposi's sarcoma, primitive neuroectodermal tumor 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
- Angiosarcoma of the trunk wall because of its diffuse frontier
- Metastatic disease (CT-scan verification) with survival expectation < 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 |
|---|---|---|
| NBTXR3One intratumor implantation by injection | Device | NBTXR3 |
Primary outcome
Evaluation of the feasibility of the intratumor injection of NBTXR3
Time frame: 6 months
- To evaluate the feasibility of NBTXR3 given as intratumor implantation (by injection) and activated by external beam radiation in patients with soft tissue sarcoma of the extremity and trunk wall
Assessment of the safety profile and determination of early dose limiting toxicity
Time frame: 20 months
- To assess the safety profile and determine the early dose limiting toxicity (DLT) of NBTXR3 intratumor implantation (by injection) and activated by external beam radiation
3 secondary outcomes
Evaluation of the anti-tumor activity of NBTXR3 in terms of pathological Response (pR)
Time frame: 20 months
Evaluation of the Response Rate (RR) of NBTXR3 as per RECIST
Time frame: 20 months
Characterization of the body kinetic profile of NBTXR3
Time frame: 20 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 Oct 2020.
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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.
Sylvie BONVALOT, MD-PhD principal investigator
Head of Surgery Division
Guy KANTOR, MD-PhD principal investigator
Head of Radiotherapy Department
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NBTXR3 in people with Adult Soft Tissue Sarcoma, run by Nanobiotix at 2 sites in France.
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 11 inclusion and 15 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 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Evaluation of the feasibility of the intratumor injection of NBTXR3 (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2020; AzTrials last refreshed its copy on 8 Nov 2026.