Quality of Life After Primary TORS vs IMRT for Patients With Early-stage Oropharyngeal Squamous Cell Carcinoma

NAActive, not recruitingINTERVENTIONAL
Enrollment

138

Participants

Timeline

Start Date

March 1, 2019

Primary Completion Date

November 30, 2025

Study Completion Date

January 31, 2029

Conditions
Oropharynx CancerOropharynx Squamous Cell CarcinomaCarcinoma, Squamous CellCarcinomaOropharyngeal NeoplasmsNeoplasms, Squamous CellNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypePharyngeal Neoplasms Malignant and UnspecifiedOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteOtorhinolaryngologic DiseasesPharyngeal DiseasesPapillomavirus InfectionsVirus DiseasesDNA Virus InfectionsTumor Virus InfectionsQuality of Life
Interventions
RADIATION

Intensity-Modulated Radiation Therapy (IMRT)

Accelerated or hyper-fractionated radiotherapy

DRUG

Cisplatin

Concurrent weekly cisplatin 40 mg/sqm to fit patients

DRUG

Nimorazole.

Concurrent nimorazole

PROCEDURE

Transoral Robotic Surgery (TORS) with neck dissection

Robotic-assisted resection of the primary oropharyngeal tumour and ipsilateral selected neck dissection of lymph node levels II-IV. Patients with a primary base of tongue cancer or with significant involvement of tongue base or the soft palate defined as above 1 cm, will be offered a bilateral neck dissection of levels II-IV.

Trial Locations (3)

Unknown

Aarhus University Hospital, Aarhus

Copenhagen University Hospital Rigshospitalet, Copenhagen

Odense University Hospital, Odense

All Listed Sponsors
collaborator

Naestved Hospital

OTHER

collaborator

Herlev Hospital

OTHER

collaborator

Aarhus University Hospital

OTHER

collaborator

Odense University Hospital

OTHER

lead

Christian von Buchwald

OTHER

NCT04124198 - Quality of Life After Primary TORS vs IMRT for Patients With Early-stage Oropharyngeal Squamous Cell Carcinoma | Biotech Hunter | Biotech Hunter