Multicenter Phase II Study of Sentinel Node Detection in Squamous Cell Carcinoma T1-T2N0 of the Oropharynx Treated With Radiotherapy and Larynx Treated by Surgery, Laser or Robot (GS-OROPHARYNX)
Head and Neck Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer
Eligibility Criteria
Inclusion Criteria:
- Squamous cell carcinoma T1 or T2 of the oropharynx or larynx, clinical and computed tomography, M0,
- previously untreated patient, without further concomitant localization,
- patient over age 18 with no upper age limit, general condition WHO 0 or 1, life expectancy greater than 2 years,
- on the cervical tomodensitometric assessment with injection of contrast agent: absence of adenomegaly suspicious of metastasis = ganglion of size less than one centimeter and 1.5 cm for group IIa, ovoid, homogeneous, not taking the contrast product And no signs of peri-ganglion invasion (fatty hyperdensity, vascular adhesion), absence of ganglionic grouping (> 3)
- Untreated patient outside a biopsy excision (melanoma experiment),
- Possibility of realizing an IMRT
- Informing the patient and signing informed consent.
Exclusion Criteria:
1) Patient already treated for this tumor outside a biopsy excision, 2) Contraindications to radiotherapy, scintigraphy or procedure, allergy to Rhenium sulphide or 99m Technetium 3) History of epidermoid carcinoma of VADS 4) Pregnant woman, likely to be pregnant or nursing, (5) Persons deprived of their liberty or under guardianship, 6) Impossibility to submit to the medical follow-up of the trial for geographical, social or psychological reasons.
7) Patient who underwent cervical surgery for any cause 8) Patient with cervical radiotherapy 9) Patient unable to undergo cervical lymph node dissection 10) Patient treated for another cancer outside the VADS within a period of less than 6 months.
Sites / Locations
- Gustave RoussyRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Oropharynx
Larynx
Tumors of the oropharynx T1T2N0 treated with radiotherapy
Tumors of the T1T2N0 larynx treated by surgery, laser or robot