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

• Status: Recruiting
• Trial end date: 2029-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Christian von Buchwald
• Collaborators: Aarhus University Hospital; Herlev Hospital; Naestved Hospital; Odense University Hospital
• Treatments: Cisplatin; Nimorazole

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 3 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