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

NCT03010553 | Unknown Phase 2

• 2 other identifiers: 2007-A00922-512006/1217
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Reliability of the sentinel lymph node technique

  Up to 24 months

Study Arms (2)

Oropharynx

EXPERIMENTAL

Tumors of the oropharynx T1T2N0 treated with radiotherapy

Procedure: Detection and resection of sentinel lymph node

Larynx

EXPERIMENTAL

Tumors of the T1T2N0 larynx treated by surgery, laser or robot

Procedure: Detection and resection of sentinel lymph node

Interventions

Detection and resection of sentinel lymph node PROCEDURE

Larynx; Oropharynx

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \) 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.
• \) 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.

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy

Villejuif, Val de Marne, 94805, France

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Antoine MOYA PLANA, MD

CONTACT

0142114603; antoine.moyaplana@gustaveroussy.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2017
• First Posted: January 5, 2017
• Study Start: February 1, 2008
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 5, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)