Clinical trial NCT03010553: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Head and Neck Cancer
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fifty patients with squamous cell carcinoma of the larynx T1 or T2N0 will therefore have a 99mTc lymphoscintigraphy per operative. The identified sentinel node will be removed along with the other lymph nodes of the selective group II and III recess. Sentinel lymph node staging alone and complete dissection with routine anatomical pathology will be compared If this technique is reliable it will make a therapeutic de-escalation in the treatment of small tumors of the larynx by limiting the ganglionic gesture in the patients whose sentinel node is free from metastasis and also to better choose the treatment in case of lymph node involvement


Eligibility criteria: Inclusion Criteria:

1. Squamous cell carcinoma T1 or T2 of the oropharynx or larynx, clinical and computed tomography, M0,
2. previously untreated patient, without further concomitant localization,
3. patient over age 18 with no upper age limit, general condition WHO 0 or 1, life expectancy greater than 2 years,
4. 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)
5. Untreated patient outside a biopsy excision (melanoma experiment),
6. Possibility of realizing an IMRT
7. 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.

Primary outcomes:
measure: Reliability of the sentinel lymph node technique
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
state: Val de Marne
Study officials:
References: