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Robotic surgery or radiation? new study compares which is better for throat cancer patients' quality of life

NCT ID NCT04124198

Symptom relief Sponsor: Christian von Buchwald Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two treatments for early-stage throat cancer: robotic surgery (TORS) or radiation therapy (IMRT). It looks at which one leads to better swallowing function and overall quality of life. About 138 adults with HPV-related throat cancer are taking part. The goal is to help patients and doctors choose the best treatment with fewer side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 138 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2019

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

carcinoma disorder of pharynx DNA Virus Infections epithelial neoplasm head and neck neoplasm Head and Neck Neoplasms human papilloma virus infection neoplasm neoplasm of oropharynx Neoplasms by Histologic Type Neoplasms by Site oropharynx cancer oropharynx squamous cell carcinoma otorhinolaryngologic disease Otorhinolaryngologic Neoplasms Pharyngeal Diseases pharynx cancer squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck squamous cell neoplasm Tumor Virus Infections viral infectious disease virus associated tumor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma Carcinoma, squamous cell DNA virus infections Head and neck neoplasms Neoplasms by histologic type Neoplasms by site Neoplasms, glandular and epithelial Neoplasms, squamous cell Oropharyngeal neoplasms Oropharynx cancer Oropharynx squamous cell carcinoma Otorhinolaryngologic diseases Otorhinolaryngologic neoplasms Papillomavirus infections Pharyngeal diseases Pharyngeal neoplasms malignant and unspecified Quality of life Tumor virus infections Virus diseases

Contacts and locations

Locations

  • Aarhus University Hospital

    Aarhus, Denmark

  • Copenhagen University Hospital Rigshospitalet

    Copenhagen, Denmark

  • Odense University Hospital

    Odense, Denmark

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