Clinical trial · Observational
IMRT and Primary Transoral Surgery in the Treatment of Squamous Cell Carcinomas
Prospective Non-randomized Comparative Study Between IMRT and Primary Transoral Surgery in the Treatment of Squamous Cell Carcinomas of Early Local Stage of Oropharynx
NCT04224389CI-TRIAL-00089424TORPHYNXrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMRT | Radiation | — | UNRESOLVED |
| transoral resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Radiotherapy
- description
- IMRT on the primitive site and the lymph nodes. +/- Concomitant chemotherapy at the discretion of the meeting multidisciplinary
- interventionNames
- Radiation: IMRT
- label
- Surgery
- description
- transoral resection of the primary tumor, with cervical lymph node dissection. Radiotherapy complementary according to the histological criteria of severity
- interventionNames
- Procedure: transoral resection
Primary outcomes (1)
- measure
- MD Anderson Dysphagia Inventory (MDADI) global score
- timeFrame
- 2 years after inclusion
- description
- Score goes from 20 to 100. A higher score means a better ability to swallow
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.