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IMRT and Primary Transoral Surgery in the Treatment of Squamous Cell Carcinomas
RECRUITINGSponsored by Gustave Roussy, Cancer Campus, Grand Paris
Actively Recruiting
SponsorGustave Roussy, Cancer Campus, Grand Paris
Started2018-06-22
Est. completion2031-06
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04224389
Summary
Compare patients' feelings in terms of swallowing ability assessed by the overall score of MD Anderson Dysphagia Inventory (MDADI) 2 years after starting treatment between patients who have been treated with IMRT and those who were treated by transoral surgery for a squamous cell carcinoma of the early stage oropharynx.
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: 1. Age ≥ 18 years old 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: 1. Severe medical comorbidity or other contraindication to radiotherapy or surgery 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
Conditions2
CancerSquamous Cell Carcinoma
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Actively Recruiting
SponsorGustave Roussy, Cancer Campus, Grand Paris
Started2018-06-22
Est. completion2031-06
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04224389