NCT04224389 IMRT and Primary Transoral Surgery in the Treatment of Squamous Cell Carcinomas
| NCT ID | NCT04224389 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
| Condition | Squamous Cell Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2018-06-22 |
| Primary Completion | 2031-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2018-06-22 with a primary completion date of 2031-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04224389 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04224389 currently recruiting?
Yes, NCT04224389 is actively recruiting participants. Contact the research team at philippe.gorphe@gustaveroussy.fr for enrollment information.
Where is the NCT04224389 trial being conducted?
This trial is being conducted at Villejuif, France, Créteil, France, Lille, France, Lyon, France and 11 additional locations.
Who is sponsoring the NCT04224389 clinical trial?
NCT04224389 is sponsored by Gustave Roussy, Cancer Campus, Grand Paris. The trial plans to enroll 150 participants.