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

NCT02855723 | Completed

• 2 other identifiers: UF 50232007- AO1191-52
• Study Type: interventional
• Target: 307
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Tumors

Keywords

Squamous carcinoma of oral cavity and oropharynx; Sentinel lymph node; Lymph node dissection; Equivalence

Outcome Measures

Primary Outcomes (1)

• Nodal recurrence rate

  The absence of recurrence at 2 years will be affirmed by the absence of clinical signs confirmed by a medical imaging exam.

  24 months after the surgery

Secondary Outcomes (5)

• Evaluation of quality of life with Head and Neck 35 (H&N35)

  At the inclusion, and at 2, 4, 6, 12 and 24 months after the surgery

• Evaluation of the costs

  At the inclusion, and at 2, 4, 6, 8, 10, 12 16, 20 and 24 months after the surgery

• Evaluation of quality of life with Quality of Life Questionnaire Core 30 (QLQ-C30)

  At the inclusion, and at 2, 4, 6, 12 and 24 months after the surgery

• Evaluation of quality of life with EuroQOL 5D (EQ 5D)

  At the inclusion, and at 2, 4, 6, 12 and 24 months after the surgery

• Evaluation of quality of life with Short Form 36 (SF36))

  At the inclusion, and at 2, 4, 6, 12 and 24 months after the surgery

Study Arms (2)

GS strategy

ACTIVE COMPARATOR

sentinel node biopsy

Other: Surgery: GS strategy

Classic strategy

OTHER

systematic lymphadenectomy

Other: Surgery: Classic strategy

Interventions

Surgery: GS strategy OTHER

sentinel node biopsy

GS strategy

Surgery: Classic strategy OTHER

systematic lymphadenectomy

Classic strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man or woman age over 18 without upper age limit
• Social Insured
• Patient Information and Informed Consent signed by the patient
• Patient not participating in another trial since the legal time
• Absence of any previous treatment for cancer of the Upper AeroDigestive Tract (VADS)
• Patient with primary squamous cell carcinoma of the oral cavity or oropharynx documented by biopsy with histopathologic analysis not older than 1 month
• curable or operable tumor with radiation under the Tumor, Nodes, Metastasis (TNM) stage, location and the patient's general condition
• Stage T1 and T2
• Tumor listed N0 satisfying the following conditions (21 days validity period): A) absence of lymphadenopathy palpable on clinical examination of the ENT investigator. B) CT scan or MRI with injection of contrast product: lack of suspicious adenomegaly for metastasis = node size less than one centimeter and 1.5 cm for the group IIa, ovoid, homogeneous, not taking contrast and showing no signs of lymph perinodal invasion ( hyperdensity fat, vascular adhesion), absence of lymph node group (\> 3)
• Systematic ENT endoscopy eliminating a second synchronous tumor and precisely establishing the T (21 days validity period)
• Absence of metastasis: M0

You may not qualify if:

• Other cancer being treated
• Non-invasive tumor: high-grade dysplasia, carcinoma in situ
• Inadequate tumor excision: margins invaded without further recovery in safe zone
• Contraindications to surgery such sentinel node or lymph node dissection
• Contraindications to radiotherapy
• Contraindications to performing a scan:
• Known allergy or intolerance to the injected product and particularly with Technetium-99
• Pregnancy
• Refusal to accept the full treatment regardless of the strategy
• Follow-up not possible
• Refusal to accept the described follow-up and / or provide the necessary information for the study
• Patient already treated for the tumor outside an excision biopsy
• Patient who previously had chemotherapy or immunotherapy for another cancer outside VADS within less than 6 months
• Patient undergoing cervical or VADS radiotherapy whatever the cause or time
• Patient who have had cervical spine surgery regardless of the cause or time

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

Location

Related Publications (1)

• Garrel R, Poissonnet G, Moya Plana A, Fakhry N, Dolivet G, Lallemant B, Sarini J, Vergez S, Guelfucci B, Choussy O, Bastit V, Richard F, Costes V, Landais P, Perriard F, Daures JP, de Verbizier D, Favier V, de Boutray M. Equivalence Randomized Trial to Compare Treatment on the Basis of Sentinel Node Biopsy Versus Neck Node Dissection in Operable T1-T2N0 Oral and Oropharyngeal Cancer. J Clin Oncol. 2020 Dec 1;38(34):4010-4018. doi: 10.1200/JCO.20.01661. Epub 2020 Oct 14.

  PMID: 33052754 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: August 4, 2016
• Study Start: April 1, 2008
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 4, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)