NCT02855723

Randomized, Open-label Economic and Medical Study on the Lymph Node Management of Squamous Cell Carcinoma of the Oral Cavity and Oropharynx Tumor Stage 1 or 2, Nodes 0 (T1-T2 N0) Operable

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 307 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study schedules the screening visit (V0) and then 9 follow-up visits during 24 months. At the screening, after verification of the eligibility criteria and signature of the informed consent form, the subject will be randomized in one of 2 arms. At the inclusion the following exams have to be done : clinical exam, panendoscopy, cytologic and histologic analysis and CT-Scan (or MRI). For each visit, the investigator will perform a clinical exam and the subjects should complete some questionnaires themselves from V0 to V3, V6 (12 months) and V9. At the last visit (24 months) the patients will have a CTC-Scan ou MRI. At the end of the follow-up period (24 months), the data of subjects survival will be recorded during three years.

Conditions

• Head and Neck Tumors

Interventions

Type	Name	Description
OTHER	Surgery: GS strategy	sentinel node biopsy
OTHER	Surgery: Classic strategy	systematic lymphadenectomy

Timeline

• Start date: 2008-04-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2016-08-04
• Last updated: 2016-08-04

Locations

1 site across 1 country: France