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

NCT ID: NCT01946867

Last Updated: 2022-12-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-03
• Study Completion Date: 2023-02-28

Brief 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. 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.

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.

Conditions

Head and Neck Cancer

Keywords

Oral cavity Cancer; Oropharynx Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NBTXR3 IntraTumoral injection (IT)

Single intratumor injection

Group Type: EXPERIMENTAL

NBTXR3 activated by IMRT

Intervention Type: DEVICE

Interventions

NBTXR3 activated by IMRT

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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
• 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

Exclusion Criteria

• 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
• 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanobiotix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe LE TOURNEAU, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Curie Paris France

Locations

Centre Francois Baclesse

Caen, , France

Centre Oscar Lambret

Lille, , France

Hôpital La Timone

Marseille, , France

Centre Antoine Lacassagne

Nice, , France

Institut Curie

Paris, , France

CHU Pontchaillou

Rennes, , France

Institut de Cancérologie de la Loire Lucien Neuwirth

Saint-Priest-en-Jarez, , France

Institut Gustave Roussy

Villejuif, , France

Hungarian Defense Forces Hospital

Budapest, , Hungary

National Institute of Oncology

Budapest, , Hungary

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

Gliwice, , Poland

Świętokrzyskie Centrum Onkologii Samodzielny Publiczny Zakład Opieki Zdrowotnej W Kielcach

Kielce, , Poland

Centrum Onkologii Ziemi Lubelskiej im. Św. Jana z Dukli

Lublin, , Poland

NU-MED, Provita Prolife

Tomaszów Mazowiecki, , Poland

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

Zamość, , Poland

Institut Catala d'Oncologia Hospital

Barcelona, , Spain

Vall d'Hebron Hospital

Barcelona, , Spain

Hospital Fundación Jimenez Diaz

Madrid, , Spain

Hospital Universitario Madrid Sanchinarro

Madrid, , Spain

Hospital Universitario Regional de Malaga

Málaga, , Spain

Countries

France; Hungary; Poland; Spain

References

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.

Reference Type: DERIVED

PMID: 33607477 (View on PubMed)

Other Identifiers

ID RCB: 2013-A00706-39

Identifier Type: OTHER

Identifier Source: secondary_id

NBTXR3-102

Identifier Type: -

Identifier Source: org_study_id