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

Summary

Oropharyngeal squamous cell carcinoma (OPSCC) is now the most frequently diagnosed head and neck cancer in Denmark which is mainly due to the increase of Human Papillomavirus (HPV). Patients with HPV-positive OPSCC have a significantly higher survival rate compared to HPV-negative OPSCC. The traditional primary treatment modality in Denmark is Intensity Modulated Radiation Therapy (IMRT), and in advanced stages in combination with chemotherapy. Since 2009, Transoral Robotic Surgery (TORS) has enabled surgeons to perform minimally invasive surgery as an alternative to standard radiotherapy treatment which is considered the primary treatment for OPSCC in many countries. There is a lack of randomised trials comparing long-term functional outcomes after TORS or IMRT. Current data are mostly derived from retrospective studies with selection bias. However, several small retrospective studies have shown promising results when comparing the two treatment modalities in favour of TORS with regards to treatment related swallowing function and quality of life (QoL) without compromising survival outcomes.

This study aims to evaluate the early and long-term functional outcomes following two treatment arms 1) TORS combined with neck dissection and 2) IMRT±concurrent chemotherapy with a special focus on swallowing-related QoL.

Conditions

• Oropharynx Cancer
• Oropharynx Squamous Cell Carcinoma
• Carcinoma, Squamous Cell
• Carcinoma
• Oropharyngeal Neoplasms
• Neoplasms, Squamous Cell
• Neoplasms, Glandular and Epithelial
• Neoplasms by Histologic Type
• Pharyngeal Neoplasms Malignant and Unspecified
• Otorhinolaryngologic Neoplasms
• Head and Neck Neoplasms
• Neoplasms by Site
• Otorhinolaryngologic Diseases
• Pharyngeal Diseases
• Papillomavirus Infections
• Virus Diseases
• DNA Virus Infections
• Tumor Virus Infections
• Quality 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.

Sponsors & Collaborators

• Naestved Hospital

  collaborator OTHER

• Herlev Hospital

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Christian von Buchwald

  lead OTHER

Principal Investigators

• Christian von Buchwald, MD, DMSc. · Department of Otorhinolaryngology, Head and Neck Surgery, Copenhagen University Hospital Rigshospitalet

• Niclas Rubek, MD · Department of Otorhinolaryngology, Head and Neck Surgery, Copenhagen University Hospital Rigshospitalet

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-01

Primary Completion

2025-12-16

Completion

2029-12-31

Countries

• Denmark

Study Locations