Etude : NBTXR3-102 /

ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.

Type d'étude
Présentation de l'étude
Acronyme : NBTXR3-102

Nom :

Traitement : Métastasique ou localement avancé / Radiothérapie

Type d'étude : Ciblage moléculaire / Innovation thérapeutique

Dernière MÀJ : 31/07/2019
CIM10 - Localisation(s)
Informations principales
Titre : Essai clinique de phase I/Phase pilote avec escalade de doses, du produit NBTXR3 activé par radiothérapie conformationelle avec modulation d'intensité (IMRT) chez des patients atteints d'un carcinome à cellules squameuses localement avancé de la cavité buccale ou de l'oropharynx

Spécialité : Lèvre, cavité buccale et pharynx
Localisation : C01 - Tumeur maligne de la base de la langue

Spécialité : Lèvre, cavité buccale et pharynx
Localisation : C02 - Tumeur maligne de la langue, parties autres et non précisées

Spécialité : Lèvre, cavité buccale et pharynx
Localisation : C03 - Tumeur maligne de la gencive

Spécialité : Lèvre, cavité buccale et pharynx
Localisation : C04 - Tumeur maligne du plancher de la bouche

Spécialité : Lèvre, cavité buccale et pharynx
Localisation : C05 - Tumeur maligne du palais

Spécialité : Lèvre, cavité buccale et pharynx
Localisation : C06 - Tumeur maligne de la bouche, parties autres et non précisées

Spécialité : Lèvre, cavité buccale et pharynx
Localisation : C10 - Tumeur maligne de l'oropharynx
Informations complémentaires
Schéma : 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.

Patients will receive a single administration of NBTXR3 on day 1, either as an intra-arterial or 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.

Phase : I

Stade : Localement avancé à Métastatique

Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Patients aged ≥ 70 years old
- Patients aged ≥ 65 years old and < 70 years old with contra-indication to cisplatin
- Patients that are intolerant to cisplatine or cetuximab or that cannot receive the combination of chemoradiation
- 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 American Joint Committee on Cancer guidelines (AJCC, 7th Edition, 2010)
- No evidence of distant metastatic disease, as determined by a negative Positron Emission Tomography (PET Scan) or Computerized Tomography (CT Scan)
- Clinically eligible for either intra-arterial or intratumor implantation by injection
- KPS Karnofsky performance status) ≥ 70
- Adequate function of Bone marrow:
White Blood Cell (WBC) > 3.0 x 109/l
Absolute neutrophil count (ANC) >= 1.0 x 109/l
Platelet count >= 100 x 109/l
Hemoglobin >= 9.0 g/dL
- Adequate function of Kidney:
Creatinine <= 1.5 x ULN or creatinine clearance >= 50 mL/min/1.73m²
- Adequate function of liver:
AST (Aspartate aminotransferase) <= 5 x ULN
ALT (Alanine aminotransferase) <= 5 x ULN
Bilirubin <= 1.5 x ULN

Critères de non-inclusion : - 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 Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- History of stroke, Coronary Artery Bypass Graft (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
Informations relatives au promoteur
Promoteur :
Type de sponsor : Industriel
75012 PARIS 12

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
Centre Oscar Lambret - 3 Rue Frédéric Combemale - 59000 LILLE

Investigateur :
Docteur Xavier MIRABEL

Unité Intégrée de Recherche Clinique

Ouverture de l'essai : OUVERT

MAJ : 14/03/2019