Status:
ACTIVE_NOT_RECRUITING
Quality of Life After Primary TORS vs IMRT for Patients With Early-stage Oropharyngeal Squamous Cell Carcinoma
Lead Sponsor:
Christian von Buchwald
Collaborating Sponsors:
Naestved Hospital
Herlev Hospital
Conditions:
Oropharynx Cancer
Oropharynx Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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-...
Detailed Description
The current study is performed as a nationwide randomized phase III study that aims to investigate the long-term functional outcomes after primary TORS and neck dissection vs. IMRT±concurrent chemothe...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Distant metastasis
- Clinically and radiologic signs of nodal extracapsular extension
- Previous radiotherapy of the head and neck
- Previous head and neck cancer
- Significant trismus (maximum inter-incisal opening ≤ 35mm) \[46\]
- Unable or unwilling to complete quality of life questionnaires
- Posterior pharyngeal wall involvement
- Pregnancy
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT04124198
Start Date
March 1 2019
End Date
December 1 2029
Last Update
December 31 2025
Active Locations (3)
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1
Aarhus University Hospital
Aarhus, Denmark
2
Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark
3
Odense University Hospital
Odense, Denmark