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

2016-08-05 07:08:22 | BioPortfolio


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.


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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Head and Neck Tumors


Surgery: GS strategy, Surgery: Classic strategy


Montpellier University Hospital




University Hospital, Montpellier

Results (where available)

View Results


Published on BioPortfolio: 2016-08-05T07:08:22-0400

Clinical Trials [11540 Associated Clinical Trials listed on BioPortfolio]

Evaluation of the Contribution of Transoral Robotic-assisted Surgery Using Da Vinci Xi for Head and Neck Tumors

Head and Neck cancers are treated either with surgical resection followed by adjuvant radiotherapy, or with organ preservation strategies using definitive radiotherapy with or without conc...

Radiotherapy vs Neck Dissection for Clinical T1/2N0 Supraglottic Cancer

Supraglottic cancer is a main type of laryngeal carcinoma, which is one of the most common head and neck tumors. Cervical nodal metastasis is an important prognostic factor in supraglottic...

Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways and combining it with chemotherapy before surgery may kill more tumor...

Nestle Impact Advanced Recovery in Improving Surgery Recovery in Patients With Head and Neck Cancer

This randomized clinical trial studies how well Nestle Impact Advanced Recovery works in improving surgery recovery in patients with head and neck cancer. Adding a nutritional supplement, ...

Soy Isoflavones in Preventing Head and Neck Cancer Recurrence in Patients With Stage I-IV Head and Neck Cancer Undergoing Surgery

This phase II clinical trial studies how well soy isoflavones work in preventing head and neck cancer in patients with stage I-IV head and neck cancer undergoing surgery. Chemoprevention i...

PubMed Articles [22234 Associated PubMed Articles listed on BioPortfolio]

Electrochemotherapy - A locoregional therapy with well-established palliative effect in patient with large recurrent lesion of head and neck.

Electrochemotherapy (ECT) is a well established treatment strategy for skin tumors of different histology. The aim of this study was to evaluate the feasibility and efficacy of electrochemotherapy in ...

Intraoperative Imaging with Second Window Indocyanine Green for Head and Neck Lesions and Regional Metastasis.

While optical imaging with near-infrared (NIR) fluorescent dye has been used in oncologic surgery, its use in the head and neck has not been established. We aimed to evaluate the feasibility of using ...

Reporting of Cosmesis in Head and Neck Reconstruction: A Systematic Review.

To identify the method and rate at which cosmesis is reported after reconstruction from head and neck surgery among adults.

When Have We Done Enough? Provider-Patient Discord in Terminal Head and Neck Cancer.

Systematic Review of Validated Quality of Life and Swallow Outcomes after Transoral Robotic Surgery.

To systematically review the available evidence on the effects of transoral robotic surgery (TORS) on the posttreatment quality of life (QOL) and swallow function of patients with head and neck cancer...

Medical and Biotech [MESH] Definitions

Dissection in the neck to remove all disease tissues including cervical LYMPH NODES and to leave an adequate margin of normal tissue. This type of surgery is usually used in tumors or cervical metastases in the head and neck. The prototype of neck dissection is the radical neck dissection described by Crile in 1906.

A strategy for purchasing health care in a manner which will obtain maximum value for the price for the purchasers of the health care and the recipients. The concept was developed primarily by Alain Enthoven of Stanford University and promulgated by the Jackson Hole Group. The strategy depends on sponsors for groups of the population to be insured. The sponsor, in some cases a health alliance, acts as an intermediary between the group and competing provider groups (accountable health plans). The competition is price-based among annual premiums for a defined, standardized benefit package. (From Slee and Slee, Health Care Reform Terms, 1993)

Discharge of cerebrospinal fluid through the nose. Common etiologies include trauma, neoplasms, and prior surgery, although the condition may occur spontaneously. (Otolaryngol Head Neck Surg 1997 Apr;116(4):442-9)

Surgical procedures conducted with the aid of computers. This is most frequently used in orthopedic and laparoscopic surgery for implant placement and instrument guidance. Image-guided surgery interactively combines prior CT scans or MRI images with real-time video.

Teaching strategy of shared learning based cross-discipline experiences and placements.

More From BioPortfolio on "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"

Quick Search


Relevant Topics

Cancer Disease
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...

Dentistry is the study, management and treatment of diseases and conditions affecting the mouth, jaw, teeth and their supporting tissues (Oxford Medical Dictionary) The work of a dentist ranges from regular patient check-up to orthodontics and surgery....

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Searches Linking to this Trial