ORL

TITRE	(EN) Phase II Study: Induction Chemotherapy Followed by Transoral Robotic Surgery and Neck Dissection for Definitive Management of Oropharyngeal Squamous Cell Carcinoma.
PROTOCOLE ID	NECTORS Trial
CLINICAL TRIAL.gov ID	NCT04277858
TYPE(S) DE CANCER	ORL
PHASE	Phase II
TYPE D'ÉTUDE	Traitement
INSTITUTION	CUSM 1001 boul. Décarie
VILLE	Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E)	Nader Sadeghi
COORDONATEUR(RICE)	Elizabeth Beaubien elizabeth.beaubien@muhc.mcgill.ca 514-934-1934 pose 34974
STATUT	Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ	(EN) Squamous cell cancer of oropharynx, p 16 positive American Joint Commission on Cancer version-7 (AJCC-7) Stage III (T1N1, T2N1, T3N0, T3N1) and stage IVa (T1N2, T2N2, T3N2) Treatment Naive No evidence of distant metastatic disease Fit for surgery, and primary tumor assessed surgically resectable with negative margins via transoral approach Age > 18 years Karnofsky performance status > 60% or Eastern Cooperative Oncology Group (ECOG) < 2 Absolute neutrophil count (ANC) > 2,000, platelets > 100,000 and calculated creatinine clearance > 50 cc/min Signed study specific consent form No other malignancies except cutaneous basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) within the last 5 years Agree to use effective contraception while on the study. Women of child bearing potential must have a negative pregnancy test, and not be lactating.
CRITÈRES D'EXCLUSION	(EN) Patients with advanced T4 cancer unresectable without organ preservation P16 negative tumor N3 disease (Stage IVB AJCC-7) 5 or more positive cervical lymph nodes at presentation Distant metastatic disease (Stage IVC) Radiological evidence of gross extracapsular nodal tumor invasion Anatomy not allowing transoral access and exposure Prior head and neck cancer at any time (Other than BCC or SCC of skin) Coexistent second malignancy or history within 5 years of prior malignancy (other than BCC or early SCC skin or curatively treated Stage I carcinoma of cervix) Peripheral neuropathy >/= grade 1 Have had prior Taxanes or Cisplatin Concurrent infection Coexisting medical illness of a severity that might interfere with treatment or follow-up, or who do not have the ability to give informed consent. Receiving any other investigational agent while on the study