Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer

Titre officiel

Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer

Sommaire:

Cet essai de phase II/III étudie l’efficacité de la biopsie du ganglion sentinelle et compare la chirurgie de biopsie du ganglion sentinelle à la dissection standard du cou dans le cadre du traitement du cancer de la cavité buccale au stade précoce. La chirurgie de biopsie du ganglion sentinelle est une procédure qui consiste à retirer un nombre inférieur de ganglions de votre cou, car elle utilise un agent de contraste pour voir quels ganglions lymphatiques sont les plus susceptibles d’être cancéreux. La dissection standard du cou, comme la dissection élective du cou, entraîne le retrait d’une grande partie des ganglions du cou. L’utilisation de la chirurgie par biopsie du ganglion sentinelle pourrait être plus efficace pour traiter les patients atteints d’un cancer de la cavité buccale à un stade précoce que la dissection standard ou élective du cou.

Description de l'essai

Primary Outcome:

• Patient-reported neck and shoulder function (Phase II/III)
• Disease-Free Survival

Secondary Outcome:

• Overall Survival
• Loco-regional Failure
• Distant metastasis
• Patient-reported shoulder-related QOL, function impairment and disability
• General quality of life
• Nodal metastasis detection rate
• Pathologic false omission rate
• Post-surgery patient-reported outcome

PRIMARY OBJECTIVES:

• To determine if patient-reported neck and shoulder function and related quality of life (QOL) at 6 months after surgery using the Neck Dissection Impairment Index (NDII) is superior with sentinel lymph node (SLN) biopsy compared to elective neck dissection (END) for treatment of early-stage oral cavity squamous cell carcinoma (OCSCC) (cT1-2N0). (Phase II)
• To determine if disease-free survival (DFS) is non-inferior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0). (Phase III)
• To determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using NDII is superior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0). (Phase III) SECONDARY
  

OBJECTIVES:

• To compare patterns of failure (local-regional relapse and distant metastasis) between surgical arms.
• To measure and compare overall survival (OS) between surgical arms.
• To measure and compare the toxicity of the two surgical arms.
• To measure longitudinal patient-reported neck and shoulder function and related QOL between surgical arms, using the following instruments:
  
  • Neck Dissection Impairment Index (NDII).
  • Abbreviated Disabilities of the Arm, Shoulder and Hand (QuickDASH).
  • Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N).
• To assess the length of hospitalization, post-operative drain placement, and operative morbidity between arms.
• To estimate the negative predictive rate of fludeoxyglucose F-18 (FDG)-positron emission tomography/computed tomography (PET/CT) for N0 neck in patients with T1 and T1-2 oral cavity squamous cell cancer (OCSCC) patients in the END arm.
• To assess nodal metastases rates between arms.
• To assess the pathologic false omission rate (FOR) in the SLN biopsy arm.
• To determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using the NDII is superior with the SLN biopsy compared to the END in low-risk patients.
  

EXPLORATORY OBJECTIVES:

• To compare changes in patient-reported outcomes (European Quality of Life Five Dimension Five Level Scale Questionnaire [EQ-5D-5L]) between surgical arms.
• To collect biospecimens for future translational science studies.
• To assess the DFS between arms in low-risk patients.
  

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive an imaging agent via injection and undergo planar imaging and single photo emission computed tomography/computed tomography (SPECT/CT) over 1-2 hours. Patients then undergo SLN biopsy.

GROUP II: Patients undergo standard END. After completion of study treatment, patients are followed up 3 weeks after surgery, every 3 months for year 1, every 4 months for year 2, every 6 months for year 3, then yearly thereafter.

Voir cet essai sur ClinicalTrials.gov