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Status unknownNCT03010553GS-OROPHARYNXUpdated Jan 5, 2017

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

A Phase 2 interventional study of Detection and resection of sentinel lymph node in Head and Neck Cancer, sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-05.

Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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

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Conditions studied

  • Head and Neck Cancer
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In context

Head and Neck Neoplasms

2,403 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.

This study's planned enrollment of 100 is above the median of 47 across 1,791 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 244 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Oropharynx

    Tumors of the oropharynx T1T2N0 treated with radiotherapy

    Procedure: Detection and resection of sentinel lymph node

  • Experimental
    Larynx

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

    Procedure: Detection and resection of sentinel lymph node

Interventions

  • ProcedureDetection and resection of sentinel lymph node
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What researchers measure

Primary outcomes

  1. Reliability of the sentinel lymph node technique

    Time frame: Up to 24 months

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03010553
Responsible party
Sponsor
First posted
Jan 5, 2017
Start date
Feb 2008
Primary completion
Dec 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Jan 5, 2017

Study contacts

Antoine MOYA PLANA, MD
Contact
antoine.moyaplana@gustaveroussy.fr
0142114603 ext. +33

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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