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

Launched by CHRISTIAN VON BUCHWALD · Oct 9, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the quality of life and functional outcomes for patients with early-stage oropharyngeal squamous cell carcinoma, which is a type of throat cancer often linked to HPV (the virus that can cause warts). The trial compares two treatment methods: Transoral Robotic Surgery (TORS), a minimally invasive surgery, and Intensity Modulated Radiation Therapy (IMRT), which uses targeted radiation. Researchers want to find out how these treatments affect patients' ability to swallow and their overall quality of life, both in the short and long term.

To participate in this trial, you must be at least 18 years old and have a confirmed diagnosis of oropharyngeal squamous cell carcinoma, with specific tumor characteristics. Participants will receive either TORS or IMRT and will be asked to complete questionnaires about their quality of life and swallowing abilities. The goal is to provide more information on which treatment option may lead to better outcomes for patients. If you meet the eligibility criteria and are interested, joining the trial could help advance understanding in this area.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18 years or older
• • 2. Able to provide informed consent
• • 3. The Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status 0-2
• • 4. Histologically confirmed oropharyngeal squamous cell carcinoma (exclusively palatine tonsils and base of tongue tumours) with known p16 status
• • 5. Clinical tumour stage cT1-2 according to The Union for International Cancer Control (UICC), tumor (T), nodes (N), and metastases (M), (TNM) classification, 8th edition.
• • 6. Clinical nodal stage cN0-1 according to UICC, TNM classification, 8th edition, however in p16 positive patients with unilateral metastasis, only a nodal metastasis up to a maximum of 4 cm in greatest diameter according to pre-operative imaging will be included.
• • 7. Diagnostic imaging including computed tomography/magnetic resonance imaging (CT/MRI) performed within 14 days at time of randomization.
• • 8. A tumour that is considered resectable according to MRI, clinical examination and/or ultrasound
• Exclusion Criteria:
• • 1. Serious medical comorbidities or ECOG/WHO performance status \>2. Other contraindications to radiotherapy, chemotherapy or surgery
• • 2. Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic
• • 3. Distant metastasis
• • 4. Clinically and radiologic signs of nodal extracapsular extension
• • 5. Previous radiotherapy of the head and neck
• • 6. Previous head and neck cancer
• • 7. Significant trismus (maximum inter-incisal opening ≤ 35mm) \[46\]
• • 8. Unable or unwilling to complete quality of life questionnaires
• • 9. Posterior pharyngeal wall involvement
• • 10. Pregnancy