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Head and Neck CancerNCT01946867

NBTXR3 and Radiation Therapy in Treating Patients With Locally Advanced SCC of the Oral Cavity or Oropharynx

A study testing NBTXR3 activated by IMRT in people with Head and Neck Cancer, run by Nanobiotix at 20 sites in 4 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

RATIONALE: Cancers of the oral cavity represent 30% of head and neck carcinomas in the western world. The oropharynx is the posterior continuation of the oral cavity and connects with the nasopharynx (above) and laryngopharynx (below). It is also a frequent site of primary head and neck cancers. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
NBTXR3 activated by IMRT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
20 sitesin 4 countries
Study dates
3 Jan 2014to Feb 2023
Phase
Interventional
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patients aged ≥ 70 years old, or
  • Patients aged ≥ 65 years old and < 70 years old who are unable to receive cisplatin, or
  • Patients who have contraindication to cisplatin or that are intolerant to cisplatin or cetuximab or that cannot receive the combination of chemoradiation, regardless the age
  • Histologically or cytologically confirmed squamous cell carcinoma (SCC) of the oral cavity or oropharynx
  • T3 or T4 primary tumor or Stage III or IVA according to AJCC guidelines (8th Edition, 2018)
  • No evidence of distant metastatic disease, as determined by a negative PET scan or CT scan
Show all 20Show fewer
  • Clinically eligible for intratumor implantation by injection
  • Karnofsky Performance Status ≥ 70
  • Adequate function of Bone marrow:
  • White Blood Cell (WBC) > 3.0 x 10^9/L
  • Absolute neutrophil count (ANC) > or = 1.0 x 10^9/L
  • Platelet count > or = 100 x 10^9/L
  • Hemoglobin > or = 9.0 g/dL
  • Adequate function of Kidney:
  • o Creatinine < or = 3.0 x ULN or creatinine clearance > or = 30 mL/min/1.73m²
  • Adequate function of the liver:
  • AST < or = 5 x ULN
  • ALT < or = 5 x ULN
  • Bilirubin < or = 1.5 x ULN
  • Negative pregnancy test ≤ 7 days of NBTXR3 injection in all females of child-bearing potential

Who cannot join

  • Written Informed Consent not obtained, signed and dated
  • Prior radiotherapy to any area within the planned radiotherapy field
  • Tumor-related dyspnea
  • Tumor ulceration which implies vascular risk
  • Non measurable disease as defined by RECIST criteria
  • History of stroke, CABG, or significant blockage of carotid arteries or coronary arteries or current blockage of coronary or carotid arteries equal to or in excess of 50% blockage
Show all 12Show fewer
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active severe infection, symptomatic congestive heart failure, acute coronary syndrome, etc.
  • Medical history of life-threatening ventricular arrhythmia
  • Prior or concurrent non-head and neck malignancies, excluding adequately treated basal or squamous cell cancer of the skin, and in situ cervical cancer, and any other cancer from which the subject has been cancer free for 5 years
  • Concurrent treatment with any other anticancer therapy, including chemotherapy, immunotherapy, targeted therapy, gene therapy, or patients planning to receive these treatments during the study
  • Patients unable to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures or those with severe psychiatric illness/social situations that would limit compliance with study requirements
  • Patients participating in another clinical investigation at the time of signature of the informed consent.

Trial locations and contacts

20 sites in 4 countries.

20 sites in 4 countries

France8 sites

  • Centre Francois Baclesse

    Caen, 14076

  • Centre Oscar Lambret

    Lille, 59000

  • Hôpital La Timone

    Marseille, 13385

  • Centre Antoine Lacassagne

    Nice, 06189

  • Institut Curie

    Paris, 75005

  • CHU Pontchaillou

    Rennes, 35033

  • Institut de Cancérologie de la Loire Lucien Neuwirth

    Saint-Priest-en-Jarez, 42270

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

Poland5 sites

  • Centrum Onkologii - Instytut im. M. Skłodowskiej- Curie, Oddział w Gliwicach

    Gliwice

  • Świętokrzyskie Centrum Onkologii Samodzielny Publiczny Zakład Opieki Zdrowotnej W Kielcach

    Kielce

  • Centrum Onkologii Ziemi Lubelskiej im. Św. Jana z Dukli

    Lublin

  • NU-MED, Provita Prolife

    Tomaszów Mazowiecki

  • Nu-Med Centrum Diagnostyki I Terapii Onkologicznej Zamość Spółka Z Ograniczoną Odpowiedzialnością

    Zamość

Other trials in Poland

Spain5 sites

  • Institut Catala d'Oncologia Hospital

    Barcelona

  • Vall d'Hebron Hospital

    Barcelona

  • Hospital Fundación Jimenez Diaz

    Madrid

  • Hospital Universitario Madrid Sanchinarro

    Madrid

  • Hospital Universitario Regional de Malaga

    Málaga, 29010

Other trials in Spain

Hungary2 sites

  • Hungarian Defense Forces Hospital

    Budapest

  • National Institute of Oncology

    Budapest

Other trials in Hungary

About this study

Official title: A Phase I Dose-Escalation/Dose Expansion Study Of NBTXR3 Activated By Intensity Modulated Radiation Therapy In Patients With Locally Advanced Squamous Cell Carcinoma Of The Oral Cavity Or Oropharynx

RATIONALE: Cancers of the oral cavity represent 30% of head and neck carcinomas in the western world. The oropharynx is the posterior continuation of the oral cavity and connects with the nasopharynx (above) and laryngopharynx (below). It is also a frequent site of primary head and neck cancers. These structures play a crucial role in swallowing, breath and speech. Locally advanced oropharyngeal cancers can obstruct the air flow or infiltrate muscles or nerves, which significantly disturb local functions. The incidence of Head and Neck Squamous Cell Cancer in patients older 65 years is high, 47% occurred in this population as recorded by the Surveillance, Epidemiology, and End Results registries in the United States. Regarding the therapeutic strategies, the association of radiotherapy with chemotherapy or biologics has demonstrated significant improvement of outcomes with the drawback of higher toxicity, or as demonstrated by 2 meta-analyses, without survival improvement in older patients. NBTXR3 and radiation therapy may increase the cancer cell killing and complete tumor shrinkage allowing a definitive treatment and preservation of local structures and functions in patients older 65 years, who cannot receive cisplatin.

Read the detailed description

Patients will receive a single administration of NBTXR3 on day 1,as an intratumor injection, followed by Intensity Modulated Radiation Therapy starting 24 hours later (Day 2), and up to completion of 7 weeks, i.e. 70 Grays, 2Grays/fraction. Patients whose tumor has completely shrunk will be followed for the post-radiotherapy evaluation up to the End of Treatment visit. Those patients whose tumor has not shrunk more than 50% of the baseline size, will stop the radiotherapy and may have a salvage tumor surgery. Then, all patients will be followed every 8 weeks, for the safety evaluation and cancer disease status until the end of the study.

Being tested
NBTXR3 activated by IMRT
Keywords
Oral cavity Cancer, Oropharynx Cancer
Medical subject headings
Head and Neck Neoplasms, Mouth Neoplasms, Oropharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NBTXR3 activated by IMRTDevice

Study groups in NCT01946867
Study groupRoleWhat they receive
NBTXR3 IntraTumoral injection (IT)ExperimentalSingle intratumor injection
Receives: Device: NBTXR3 activated by IMRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Escalation: Incidence of DLTs and determination of the Recommended Phase 2 Dose

    The incidence of early DLTs (early adverse effects related to NBTXR3, as an intratumor injection, activated by IMRT)

    Measured: 12 months

  2. Dose Escalation: Determination of the Recommended Phase 2 Dose

    The recommended Phase II dose (RD) of NBTXR3 administered as intratumor injection, activated by Intensity Modulated Radiation Therapy (IMRT)

    Measured: 12 months

  3. Dose Expansion: Overall Response Rate

    The Objective Response Rate (ORR) of the primary tumor, by imaging according to RECIST 1.1

    Measured: 12-24 months

  4. Dose Expansion: Complete Response Rate

    The Complete Response Rate (CRR) of the primary tumor, by imaging according to RECIST 1.1

    Measured: 12-24 months

Secondary outcomes (4)

  1. Dose Escalation: Objective Response Rate (ORR) of the primary tumor

    The Objective Response Rate (ORR) of the primary tumor, by imaging according to RECIST 1.1

    Measured: 12-24 months

  2. Dose Escalation: Complete Response Rate

    The Complete Response Rate (CRR) of the primary tumor, by imaging according to RECIST 1.1

    Measured: 12 months

  3. Dose Expansion: Local Progression Free Survival

    Local Progression Free Survival (LPFS) defined as any recurrence at the site of the primary tumor

    Measured: 12-24 months

  4. Dose Expansion: Progression Free Survival

    Progression Free Survival (PFS) defined as the time to any progression at the site of the primary tumor, in regional lymph nodes and/or distant metastasis

    Measured: 12-24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2013 (estimated)
  2. Study start3 Jan 2014
  3. Primary completionFeb 2023 (estimated)
  4. Study completionFeb 2023 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This study consists of two parts: Dose Escalation and Dose Expansion. This phase I is an open-label non-randomized, dose-escalation/dose expansion study of safety and tolerability evaluation of NBTXR3, administered as an intratumoral implantation by injection, activated by intensity modulated radiation therapy (IMRT), in patients with locally advanced squamous cell carcinoma of the oral cavity or oropharynx.
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01946867
Sponsor's protocol ID
NBTXR3-102
Other IDs
ID RCB: 2013-A00706-39
Status last verified
Dec 2022
First submitted
10 Sep 2013
Last updated
29 Dec 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Le Tourneau C, Liem X, Nguyen F, Deraedt S, Salas S, Calugaru V, Serrahima MP, Wong Hee Kam S, Hoffmann C, Lesnik M, Blanchard P, Poissonnet G, Bozec A, Saada-Bouzid E, Jegoux F, Castelli J, Devisetty K, Lelonge Y, Jadaud E, Houdas L, Debard A, Vivar OI, Finzi L, Serra A, Linares I, Arranz Obispo C, Thariat J, Rambeau A, Fakhry N, Santini L, Giralt J, Brana Garcia I, Barba MS, Gorphe P, Helfferich F, Herczeg A, Papai Z, Fijuth J, Takacsi-Nagy Z. Intratumoral Radioenhancer Nanoparticle NBTXR3 Followed by Radiotherapy in Head and Neck Cancer: A Phase 1 Dose-Expansion Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2026 Mar 1;152(3):284-293. doi: 10.1001/jamaoto.2025.4939.

    PubMed 41609775

  • Hoffmann C, Calugaru V, Borcoman E, Moreno V, Calvo E, Liem X, Salas S, Doger B, Jouffroy T, Mirabel X, Rodriguez J, Chilles A, Bernois K, Dimitriu M, Fakhry N, Hee Kam SW, Le Tourneau C. Phase I dose-escalation study of NBTXR3 activated by intensity-modulated radiation therapy in elderly patients with locally advanced squamous cell carcinoma of the oral cavity or oropharynx. Eur J Cancer. 2021 Mar;146:135-144. doi: 10.1016/j.ejca.2021.01.007. Epub 2021 Feb 16.

    PubMed 33607477

Questions about this trial

What is this clinical trial studying?

A study testing NBTXR3 activated by IMRT in people with Head and Neck Cancer, run by Nanobiotix at 20 sites in 4 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 20 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France, Poland, Spain, Hungary. 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.

Are results available for this study?

Results are not available in the source record.

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?

Dose Escalation: Incidence of DLTs and determination of the Recommended Phase 2 Dose (time frame: 12 months). The study lists 4 primary outcomes in all. 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 NCT01946867, which also lists 2 linked publications.

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 29 Dec 2022.

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