Status
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Failure of one of the inclusion criteria
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:
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
Primary purpose
Allocation
Interventional model
Masking
307 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal