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
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
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 →Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 244 studies on the registry; 66 are open to participants now.
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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.
Tumors of the oropharynx T1T2N0 treated with radiotherapy
Procedure: Detection and resection of sentinel lymph node
Tumors of the T1T2N0 larynx treated by surgery, laser or robot
Procedure: Detection and resection of sentinel lymph node
Reliability of the sentinel lymph node technique
Time frame: Up to 24 months
Plan to share: No
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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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Gustave Roussy, Cancer Campus, Grand Paris →