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

Head and Neck Cancer Clinical Trial

— GS-OROPHARYNX  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03010553
• Other study ID #: 2007-A00922-51
• Secondary ID: 2006/1217
• Status: Recruiting
• Phase: Phase 2
• First received: January 2, 2017
• Last updated: January 2, 2017
• Start date: February 2008
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Antoine MOYA PLANA, MD
• Phone: 0142114603
• Email: antoine.moyaplana[@]gustaveroussy.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Procedure:
• Detection and resection of sentinel lymph node

Locations

Country	Name	City	State
France	Gustave Roussy	Villejuif	Val de Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability of the sentinel lymph node technique		Up to 24 months	No