IMRT and Primary Transoral Surgery in the Treatment of Squamous Cell Carcinomas
NCT ID: NCT04224389
Last Updated: 2025-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2018-06-22
2031-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Radiotherapy
IMRT on the primitive site and the lymph nodes. +/- Concomitant chemotherapy at the discretion of the meeting multidisciplinary
IMRT
Intensity modulation radiotherapy (RCMI or IMRT) will be performed using techniques static or rotational (arctherapy, tomotherapy). Restraint is recommended with thermoformed mask
Surgery
transoral resection of the primary tumor, with cervical lymph node dissection. Radiotherapy complementary according to the histological criteria of severity
transoral resection
The technique of transoral surgery will be left to the choice of the surgeon according to the equipment and the experience of the team and will be gathered. The options are: transoral surgery robot-assisted, endoscopic laser transoral surgery, transoral laser surgery classical instruments. The exact description of the resected area will be collected. of the cross-sections will be made for extemporaneous analysis if necessary in lateral margins and deep until complete excision.
Interventions
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transoral resection
The technique of transoral surgery will be left to the choice of the surgeon according to the equipment and the experience of the team and will be gathered. The options are: transoral surgery robot-assisted, endoscopic laser transoral surgery, transoral laser surgery classical instruments. The exact description of the resected area will be collected. of the cross-sections will be made for extemporaneous analysis if necessary in lateral margins and deep until complete excision.
IMRT
Intensity modulation radiotherapy (RCMI or IMRT) will be performed using techniques static or rotational (arctherapy, tomotherapy). Restraint is recommended with thermoformed mask
Eligibility Criteria
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Inclusion Criteria
2. ECOG performance status 0-2
3. Histologically confirmed squamous cell carcinoma
4. Primitive localization of the oropharynx on the tonsil compartment or the tongue base
5. p16 or HPV status available
6. TNM classification AJCC7th T1 or T2
7. TNM classification AJCC7th N0 or N1
8. Patient and tumor that can be treated by radiotherapy or by transoral surgery
9. Patient who has not objected to participate after being informed about the study. The patient must be able and willing to cooperate in follow-up and study visits
Exclusion Criteria
2. Primary tumor or unresectable lymphadenopathy
3. Metastatic disease
4. History of squamous cell carcinoma of the head and neck within 5 years
5. History of radiation therapy to the head and neck
6. Inability to undergo or complete radiation therapy follow-up consultations
7. History of cancer except free of any disease for at least 5 years, with the exception of non-melanoma skin cancers
8. Inability to complete questionnaires
9. Pregnant or lactating woman
10. Patient under tutorship or curatorship, deprived of liberty or unable to do so to express consent
18 Years
ALL
No
Sponsors
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Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Responsible Party
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Locations
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Gustave Roussy
Villejuif, Val De Marne, France
Centre Hospitalier InterCommunal
Créteil, , France
Centre Oscar Lambret
Lille, , France
Hôpital la Croix Rousse
Lyon, , France
Centre Léon Bérard
Lyon, , France
CHU Conception
Marseille, , France
CHU Montpellier
Montpellier, , France
CHU Nantes - Hôtel Dieu
Nantes, , France
Institut Universitaire de la face et du cou
Nice, , France
Hôpital Européen Georges Pompidou
Paris, , France
CHU Reims
Reims, , France
Hôpital Charles Nicolle
Rouen, , France
CHU Hôpital de Hautepierre
Strasbourg, , France
Institut Claudius Regaud
Toulouse, , France
CHU Tours
Tours, , France
CHRU Nancy - Hôpital de Brabois
Vandœuvre-lès-Nancy, , France
Countries
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Central Contacts
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Facility Contacts
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Héloïse DE KERMADEC, MD
Role: primary
Sophie DENEUVE, MD
Role: primary
Haitham MIRGHANI, MD
Role: primary
Esteban BRENET, MD
Role: primary
Romina MASTRONICOLA, MD
Role: primary
Other Identifiers
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2017/2617
Identifier Type: OTHER
Identifier Source: secondary_id
2017-A02253-50
Identifier Type: -
Identifier Source: org_study_id
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