Comparing swallowing ability after different treatments for early-stage oropharyngeal cancer
Prospective Non-randomized Comparative Study Between IMRT and Primary Transoral Surgery in the Treatment of Squamous Cell Carcinomas of Early Local Stage of Oropharynx
This study is trying to see if patients with early-stage throat cancer swallow better after getting either radiation therapy or surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris Academic / other |
| Drugs / interventions | radiation |
| Locations | 16 sites (Villejuif, Val De Marne and 15 other locations) |
| Trial ID | NCT04224389 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the swallowing ability of patients with early-stage squamous cell carcinoma of the oropharynx who have undergone either intensity-modulated radiation therapy (IMRT) or transoral surgery. The assessment will be based on the MD Anderson Dysphagia Inventory (MDADI) scores collected two years post-treatment. The study will include patients aged 18 and older with confirmed diagnoses and specific tumor characteristics, while excluding those with severe comorbidities or metastatic disease.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with early-stage squamous cell carcinoma localized to the oropharynx.
Not a fit: Patients with severe medical comorbidities, metastatic disease, or a history of head and neck cancer within the last five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into which treatment option offers better swallowing outcomes for patients with early-stage oropharyngeal cancer.
How similar studies have performed: Other studies have explored treatment outcomes for oropharyngeal cancer, but this specific comparison of IMRT and transoral surgery is less common and may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Villejuif, Val De Marne and 15 other locations
- Gustave Roussy — Villejuif, Val De Marne, France (Recruiting)
- Centre Hospitalier InterCommunal — Créteil, France (Recruiting)
- Centre Oscar Lambret — Lille, France (Recruiting)
- Hôpital la Croix Rousse — Lyon, France (Recruiting)
- Centre Léon Bérard — Lyon, France (Recruiting)
- CHU Conception — Marseille, France (Recruiting)
- CHU Montpellier — Montpellier, France (Recruiting)
- CHU Nantes - Hôtel Dieu — Nantes, France (Recruiting)
- Institut Universitaire de la face et du cou — Nice, France (Recruiting)
- Hôpital Européen Georges Pompidou — Paris, France (Recruiting)
- CHU Reims — Reims, France (Recruiting)
- Hôpital Charles Nicolle — Rouen, France (Recruiting)
- CHU Hôpital de Hautepierre — Strasbourg, France (Recruiting)
- Institut Claudius Regaud — Toulouse, France (Recruiting)
- CHU Tours — Tours, France (Recruiting)
- CHRU Nancy - Hôpital de Brabois — Vandœuvre-lès-Nancy, France (Recruiting)
Study contacts
- Study coordinator: Philippe Gorphe, MD
- Email: philippe.gorphe@gustaveroussy.fr
- Phone: +33 (0)1 42 11 42 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.