Quality of Life After Primary TORS vs IMRT for Patients With Early-stage Oropharyngeal Squamous Cell Carcinoma
QoLATI
2 other identifiers
interventional
138
1 country
3
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-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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2019
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 6, 2019
CompletedFirst Posted
Study publicly available on registry
October 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
ExpectedDecember 31, 2025
December 1, 2025
6.8 years
October 6, 2019
December 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Swallowing related quality of life by MDADI
Difference in swallowing related quality of life measured by a composite MD Anderson Dysphagia Inventory (MDADI) score. The MDADI is a 20-item self-administered questionnaire that quantifies swallowing-related quality of life. Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). The composite MDADI score summarizes overall performance on remaining 19-items of the MDADI, as a weighted average of the physical, emotional, and functional subscale questions. Summary and subscale MDADI scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning).
evaluated at baseline, 3 and 12 months after treatment
Secondary Outcomes (16)
Nasogastric or percutaneus tube dependency
evaluated at baseline, 3 and 12 months after treatment
Swallowing function by fiberendoscopic evaluation
evaluated at baseline, 3 and 12 months after treatment
Swallowing function by modified barium swallowing
evaluated at baseline, 3 and 12 months after treatment
Patient reported quality of life by EORTC-QLQ-H&N35
evaluated at baseline, 3 and 12 months after treatment
Patient reported quality of life by EORTC QLQ-C30
evaluated at baseline, 3 and 12 months after treatment
- +11 more secondary outcomes
Study Arms (2)
Transoral robotic surgery (TORS)
EXPERIMENTALIntensity-Modulated Radiation Therapy (IMRT)
ACTIVE COMPARATORPatients with clinical T1N0 stage are offered accelerated radiotherapy to 66 Gy/33fractions with concurrent nimorazole. Patients with clinical T2N0 stage are offered either accelerated radiotherapy to 66 Gy/33fractions with the option of weekly cisplatin to fit patients or hyper-fractionated accelerated radiotherapy to 76 Gy/56fractions both with concurrent nimorazole. Patients with clinical T1-T2, N1 stage are offered accelerated radiotherapy to 66 Gy/33 fractions and nimorazole with the addition of concurrent weekly cisplatin 40 mg/sqm to fit patients.
Interventions
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.
Accelerated or hyper-fractionated radiotherapy
Concurrent weekly cisplatin 40 mg/sqm to fit patients
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Naestved Hospitalcollaborator
- Herlev Hospitalcollaborator
- Odense University Hospitalcollaborator
- Christian von Buchwaldlead
- Aarhus University Hospitalcollaborator
Study Sites (3)
Aarhus University Hospital
Aarhus, Denmark
Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Christian von Buchwald, MD, DMSc.
Department of Otorhinolaryngology, Head and Neck Surgery, Copenhagen University Hospital Rigshospitalet
- PRINCIPAL INVESTIGATOR
Niclas Rubek, MD
Department of Otorhinolaryngology, Head and Neck Surgery, Copenhagen University Hospital Rigshospitalet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Professor and Study Chair
Study Record Dates
First Submitted
October 6, 2019
First Posted
October 11, 2019
Study Start
March 1, 2019
Primary Completion
December 16, 2025
Study Completion (Estimated)
December 1, 2029
Last Updated
December 31, 2025
Record last verified: 2025-12