NCT04124198Active, not recruiting
Quality of Life After Primary TORS vs IMRT for Patients With Early-stage Oropharyngeal Squamous Cell Carcinoma
Quality of Life After Primary Transoral Robotic Surgery vs Intensity-modulated Radiotherapy for Patients With Early-stage Oropharyngeal Squamous Cell Carcinoma: A Randomized National Trial
Source: ClinicalTrials.gov · Last updated 31 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 138 (estimated)
- First submitted
- 6 Oct 2019
- Start date
- 1 Mar 2019
- Primary completion date
- 16 Dec 2025
- Lead sponsor
- Christian von Buchwald
- Diseases
- Head and neck cancer
- NCT number
- NCT04124198
What you commit to
- Study type: Interventional
- Planned participants: 138
- From 1 Mar 2019 to the primary completion date, 16 Dec 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Serious medical comorbidities or ECOG/WHO performance status \>2. Other contraindications to radiotherapy, chemotherapy or surgery
- Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic
- Previous radiotherapy of the head and neck
- Previous head and neck cancer
Other
- Distant metastasis
- Clinically and radiologic signs of nodal extracapsular extension
- Significant trismus (maximum inter-incisal opening ≤ 35mm) \[46\]
- Unable or unwilling to complete quality of life questionnaires
- Posterior pharyngeal wall involvement
- Pregnancy
Who the study is looking for
- 18 years or older
- Able to provide informed consent
- The Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status 0-2
- Histologically confirmed oropharyngeal squamous cell carcinoma (exclusively palatine tonsils and base of tongue tumours) with known p16 status
- 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.
- 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.
- Diagnostic imaging including computed tomography/magnetic resonance imaging (CT/MRI) performed within 14 days at time of randomization.
- A tumour that is considered resectable according to MRI, clinical examination and/or ultrasound
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Copenhagen University Hospital, Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.