Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized, Open-label Economic and Medical Study on the Lymph Node Management of Squamous Cell Carcinoma of the Oral Cavity and Oropharynx T1-T2N0 Operable : Comparison of the Reference Strategy Based on a the Systematic Lymph Node Dissection Versus the Strategy Based on the Technique of Sentinel Lymph Node.
Brief Summary: Currently, patients with cancer of oral cavity or oropharynx T1-T2N0 classified, are treated surgically with systematic lymph node dissection while in 70%, there is no lymph node metastasis. The technique of identifying the sentinel node (GS) is validated for these tumors because the status of the sentinel node is predictive of the other nodes status in the neck. This helps to diagnose the presence of metastases without lymph node dissection and thus select patients requiring a treatment node. However, the oncological and functional results of a therapeutic strategy based on identifying the GS is unknown.

This open-label randomized multicenter clinical trial aims to compare the oncologic and functional outcome of two strategies : the current management versus the management based on the sentinel lymph node.

The hypothesis is based on a nodal control difference at 2 years in both arms not exceeding 10%. The medico-economic analysis will be conducted in two stages : a classic stage on 2 years with estimated incremental cost-effectiveness and incremental cost-utility, then a step with log term modeling.

A reduction in morbidity and treatment costs in the sentinel node arm are expected in this study.


Options:
A: Arm Label: Group 1 (Not 2B); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Selective Neck Dissection Excluding Level 2B | Arm Label: Group 2 (2B); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Selective Neck Dissection Including Level 2B | Intervention Type: PROCEDURE; Name: Selective Neck Dissection Excluding Level 2B; Assigned to Arm(s): Group 1 (Not 2B) | Intervention Type: PROCEDURE; Name: Selective Neck Dissection Including Level 2B; Assigned to Arm(s): Group 2 (2B)
B: Arm Label: GS strategy; Type: ACTIVE_COMPARATOR; Interventions: Other: Surgery: GS strategy | Arm Label: Classic strategy; Type: OTHER; Interventions: Other: Surgery: Classic strategy | Intervention Type: OTHER; Name: Surgery: GS strategy; Assigned to Arm(s): GS strategy | Intervention Type: OTHER; Name: Surgery: Classic strategy; Assigned to Arm(s): Classic strategy
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Procedure: Selective neck dissection | Arm Label: 2; Type: OTHER; Interventions: Procedure: Conventional Neck dissection | Intervention Type: PROCEDURE; Name: Selective neck dissection; Assigned to Arm(s): 1 | Intervention Type: PROCEDURE; Name: Conventional Neck dissection; Assigned to Arm(s): 2
D: Arm Label: Wait and Watch; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Therapeutic Neck Dissection | Arm Label: Elective Neck dissection; Type: EXPERIMENTAL; Interventions: Procedure: Elective neck dissection in early oral cancer | Intervention Type: PROCEDURE; Name: Elective neck dissection in early oral cancer; Assigned to Arm(s): Elective Neck dissection | Intervention Type: PROCEDURE; Name: Therapeutic Neck Dissection; Assigned to Arm(s): Wait and Watch

Answer: B