Oropharynx CancerQoLATINCT04124198
Quality of Life After Primary TORS vs IMRT for Patients With Early-stage Oropharyngeal Squamous Cell Carcinoma
A study testing Intensity-Modulated Radiation Therapy (IMRT), Cisplatin and Nimorazole. in people with Oropharynx Cancer and Oropharynx Squamous Cell Carcinoma, run by Christian von Buchwald at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharynx Cancer, Oropharynx Squamous Cell Carcinoma, Carcinoma, Squamous Cell
- What is being tested?
- Intensity-Modulated Radiation Therapy (IMRT), Cisplatin and Nimorazole.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 3 sitesDenmark
- Study dates
- 1 Mar 2019to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Significant trismus (maximum inter-incisal opening ≤ 35mm) [46]
- Unable or unwilling to complete quality of life questionnaires
- Posterior pharyngeal wall involvement
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Aarhus University Hospital
Aarhus
Copenhagen University Hospital Rigshospitalet
Copenhagen
Odense University Hospital
Odense
About this study
Official title: 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
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.
Read the 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 chemotherapy for early-stage oropharyngeal squamous cell carcinoma.
The study is a registered Danish Head and Neck Cancer Group (DAHANCA) 34 protocol.
The investigators hypothesise that primary TORS±adjuvant therapy will significantly improve the QoL at 12 months follow-up compared to IMRT±concurrent chemotherapy.
Primary endpoint: QoL measured by a composite MD Anderson Dysphagia Inventory (MDADI) score evaluated at 12 months follow-up after treatment (10-point difference)
Study design:
Patients who meet the inclusion criteria will be recruited from three Danish head and neck cancer centers: Copenhagen University Hospital Rigshospitalet, Aarhus University Hospital and Odense University Hospital.
Prior to treatment, all patients will be reviewed and examined at a multidisciplinary team conference.
Included patients will be randomized in 2:1 ratio:
Arm 1 (experimental), n=92 patients: TORS+neck dissection. Arm 2 (control), n=46 patients: IMRT±concurrent chemotherapy
DAHANCA Secretariat is responsible for the randomization key to either experimental or control arm. The investigators will stratify for p16, sex, tumour location and clinical tumor- and nodal-stage (T- and N-stage) classification at time of inclusion to avoid an uneven distribution in the experimental arm compared to the control arm.
Specifics for the experimental arm:
Patients with clinically positive neck (cN+) will be offered a staging neck within 8 days prior to the planned TORS. Based on final pathology of the neck specimen, patients will either be referred for definitive IMRT± concurrent chemotherapy (extracapsular extension (ECE), or more than two lymph node metastases) or they will undergo TORS (no extracapsular exension and maximally two lymph node metastases).
For patients with clinically no evidence of lymph node metastasis (cN0), neck dissection can be performed either before (within 8 days) or concurrently (same day procedure) with TORS.
Indications for adjuvant radiotherapy:
Nodal site:
- More than two lymph node metastases
- Two lymph node metastases and both above 1 cm in diameter.
- Any pathological positive lymph nodes (pN+) with extracapsular extension (ECE)
- A neck dissection nodal yield of less than 10 lymph nodes per side (after total embedding of the remaining fat tissue)
Tumour site:
- Involved or close resection margins of < 2 mm if free margins was not obtained after supplementary resections per-operatively or after re-resection in a secondary procedure.
- In case of stage migration to tumour stages T3 or T4, in an otherwise radical operation (R0), adjuvant therapy will be offered based on a postoperative consultation between the patient, the surgeon and an oncologist.
Indications for adjuvant chemotherapy:
- Insufficient resection margin (<2mm) or ECE
Specifics for the control arm:
Radiotherapy Quality Assurance Reviews are aimed to be performed before the third treatment fraction by a team from another head-neck oncology center consisting of one physicist and one oncologist. The patient specific review will address the following points according to the DAHANCA guideline: Clinical Target Volume (CTV) and Organs-at-Risk (OAR) delineation, target dose coverage, OAR dose sparing and treatment length.
Funding: The study protocol was initiated by the Department of Otorhinolaryngology, Head \& Neck surgery at Copenhagen University Hospital Rigshospitalet. Funding grants have been received by the Danish Health Authority ("Midler til eksperimentel kræftkirurgi"), by the Copenhagen University Hospital Rigshospitalet ("Rammebevilling") and Odense University Hospital ("Forskningspulje mellem OUH og RH").
Data management and ethical considerations: Data is stored and handled in accordance with the Danish Data Agency regulations, The General Data Protection Regulation (GDPR) 2016/679 in European Union (EU) law on data protection and privacy for all individual citizens of the EU and the European Economic Area (EEA), and in compliance with the national data agreement between the study locations in compliance with the Danish Data Protection Agency approval (ID: RH-2017-362).
During the trial, the Good Clinical Practice (GCP) unit in Aarhus will monitor the study trial according to the given protocol and the current legislation. The monitoring period will consist of the first 12 months of inclusion until the primary endpoint.
This study has been approved by the Regional Committee on Health Research Ethics (ID: H-17031827)
- Conditions
- Oropharynx Cancer, Oropharynx Squamous Cell Carcinoma, Carcinoma, Squamous Cell, Carcinoma, Oropharyngeal Neoplasms, Neoplasms, Squamous Cell
- Being tested
- Intensity-Modulated Radiation Therapy (IMRT), Cisplatin, Nimorazole., Transoral Robotic Surgery (TORS) with neck dissection
- Keywords
- Oropharyngeal squamous cell carcinoma T1-T2, N0-1, Transoral robotic surgery, Intensity Modulated Radiation Therapy
- Medical subject headings
- Oropharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell, Carcinoma, Neoplasms, Squamous Cell, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Otorhinolaryngologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity-Modulated Radiation Therapy (IMRT)Radiation
Accelerated or hyper-fractionated radiotherapy
CisplatinDrug
Concurrent weekly cisplatin 40 mg/sqm to fit patients
Nimorazole.Drug
Concurrent nimorazole
Transoral Robotic Surgery (TORS) with neck dissectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Transoral robotic surgery (TORS) | Experimental | Not described Receives: Procedure: Transoral Robotic Surgery (TORS) with neck dissection |
| Intensity-Modulated Radiation Therapy (IMRT) | Active comparator | Patients 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. Receives: Radiation: Intensity-Modulated Radiation Therapy (IMRT); Drug: Cisplatin; Drug: Nimorazole. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: evaluated at baseline, 3 and 12 months after treatment
Secondary outcomes (16)
Nasogastric or percutaneus tube dependency
Tube dependency defined as number of days/weeks/months with tube inserted
Measured: evaluated at baseline, 3 and 12 months after treatment
Swallowing function by fiberendoscopic evaluation
Fiberendoscopic Evaluation of Swallowing (FEES) is rated by following scales: a 8-point Penetration-Aspiration Scale (PAS) where a score of 1 reflects no entry of material into the airway, scores of 2-5 reflect penetration of material past the laryngeal additus into the supraglottic space and traveling as far as the true vocal folds, while scores of 6-8 reflect tracheal aspiration of material below the true vocal folds; Yale Pharyngeal Residue Severity Rating Scale: image-based assessment of post-swallow pharyngeal residue severity as observed during swallowing. Five-point ordinal rating scale based on residue location (vallecula and pyriform sinus) and amount (none, trace, mild, moderate, and severe); the summary DIGEST grading: grade 1= mild, grade 2= moderate, grade 3= severe, and grade 4= life threatening pharyngeal dysphagia.
Measured: evaluated at baseline, 3 and 12 months after treatment
Swallowing function by modified barium swallowing
Modified Barium Swallowing (MBS) is a fluoroscopic procedure designed to determine whether food or liquid is aspirated. Following scales are used to assess MBS: a 8-point Penetration-Aspiration Scale (PAS): a score of 1 reflects no entry of material into the airway, scores of 2-5 reflect penetration of material past the laryngeal additus into the supraglottic space and traveling as far as the true vocal folds, while scores of 6-8 reflect tracheal aspiration of material below the true vocal folds; the summary DIGEST grading: grade 1= mild, grade 2= moderate, grade 3= severe, and grade 4= life threatening pharyngeal dysphagia.
Measured: evaluated at baseline, 3 and 12 months after treatment
Patient reported quality of life by EORTC-QLQ-H&N35
Measured by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaires EORTC-QLQ-H\&N35. The head and neck-specific module EORTC QLQ-H\&N35 contains 35 items, which can be condensed into 7 multi-item and 11 single-item scales. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: evaluated at baseline, 3 and 12 months after treatment
Patient reported quality of life by EORTC QLQ-C30
Measured by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire EORTC QLQ-C30. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: evaluated at baseline, 3 and 12 months after treatment
Treatment-related pain
Daily (experimental arm) or weekly (control arm) self-reported visual analogue scale (VAS) score from 0-10 points in which a higher score indicates greater pain intensity. Measured until no treatment-related pain is recorded by the patient and with no need of treatment-related pain medication
Measured: evaluated at baseline up to 12 months after treatment
Weight
Measured: evaluated at baseline, 3 and 12 months after treatment
Patients returning to work after treatment
Defined as the time (number of days) before returning to work or failure to do so after treatment.
Measured: evaluated at baseline, 3 and 12 months after treatment
Morbidity after staging neck after staging neck dissection
Monitoring of events of bleeding, lymphedema or impaired nerve function after staging neck dissection
Measured: evaluated from time of neck dissection up to 14 days after treatment
Nerve function
Evaluation of nerve function at risk during surgery (spinal accessory, hypoglossal, marginal mandibular branch of the facial nerve, lingual and vagal nerve) will be assessed by a clinical examination based on the innervation and function of each nerve during follow-up after surgery. Nerve function is determined as dichotomous variable: functioning/not-functioning.
Measured: evaluated at baseline and up to 12 months after treatment
Late toxicity
Using The Radiation Therapy Oncology Group/The European Organization for Research and Treatment of Cancer (RTOG/EORTC) Late Radiation Morbidity Score. Uses a grading system from 0-5 for different tissue organs: 0 - no symptoms, 5 - death directly related to radiation effects
Measured: evaluated at 3, 6, 12, 24, 36, 48 and 60 months after treatment
Overall survival
Time from randomization to death from any cause.
Measured: evaluated from time of randomization up to 5 years
Disease-free survival
Time from randomization to sign of cancer is found.
Measured: evaluated from time of randomization up to 5 years
Disease-specific survival
Time from randomization to death from the disease (oropharyngeal cancer).
Measured: evaluated from time of randomization up to 5 years
Distant recurrence
Time from randomization to distant recurrence
Measured: evaluated from time of randomization up to 5 years
Loco-regional recurrence
Time from randomization to recurrence in same T-site or N-site as initial cancer localization
Measured: evaluated from time of randomization up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start1 Mar 2019
- Primary completion16 Dec 2025
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharynx CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian von Buchwald
- Sponsor type
- University, hospital or other
- Collaborators
- Naestved Hospital, Herlev Hospital, Aarhus University Hospital, Odense University Hospital
- Responsible party
- Sponsor-investigator, Christian von Buchwald, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Christian von Buchwald, MD, DMSc., Study chair, Department of Otorhinolaryngology, Head and Neck Surgery, Copenhagen University Hospital RigshospitaletNiclas Rubek, MD, Principal investigator, Department of Otorhinolaryngology, Head and Neck Surgery, Copenhagen University Hospital Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124198
- Sponsor's protocol ID
- The QoLATI Study
- Other IDs
- DAHANCA 34
- Acronym
- QoLATI
- Status last verified
- Dec 2025
- First submitted
- 6 Oct 2019
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04124198
- Acronym / sponsor ID
- QoLATI / The QoLATI Study
- Conditions
- Oropharynx Cancer, Oropharynx Squamous Cell Carcinoma, Carcinoma, Squamous Cell, Carcinoma, Oropharyngeal Neoplasms, Neoplasms, Squamous Cell
- Keywords
- Oropharyngeal squamous cell carcinoma T1-T2, N0-1, Transoral robotic surgery, Intensity Modulated Radiation Therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Christian von BuchwaldUniversity, hospital or other
- Collaborators
- Naestved Hospital, Herlev Hospital, Aarhus University Hospital, Odense University Hospital
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- Dec 2029 (estimated)
- First posted
- 11 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 chemotherapy for early-stage oropharyngeal squamous cell carcinoma.
The study is a registered Danish Head and Neck Cancer Group (DAHANCA) 34 protocol.
The investigators hypothesise that primary TORS±adjuvant therapy will significantly improve the QoL at 12 months follow-up compared to IMRT±concurrent chemotherapy.
Primary endpoint: QoL measured by a composite MD Anderson Dysphagia Inventory (MDADI) score evaluated at 12 months follow-up after treatment (10-point difference)
Study design:
Patients who meet the inclusion criteria will be recruited from three Danish head and neck cancer centers: Copenhagen University Hospital Rigshospitalet, Aarhus University Hospital and Odense University Hospital.
Prior to treatment, all patients will be reviewed and examined at a multidisciplinary team conference.
Included patients will be randomized in 2:1 ratio:
Arm 1 (experimental), n=92 patients: TORS+neck dissection. Arm 2 (control), n=46 patients: IMRT±concurrent chemotherapy
DAHANCA Secretariat is responsible for the randomization key to either experimental or control arm. The investigators will stratify for p16, sex, tumour location and clinical tumor- and nodal-stage (T- and N-stage) classification at time of inclusion to avoid an uneven distribution in the experimental arm compared to the control arm.
Specifics for the experimental arm:
Patients with clinically positive neck (cN+) will be offered a staging neck within 8 days prior to the planned TORS. Based on final pathology of the neck specimen, patients will either be referred for definitive IMRT± concurrent chemotherapy (extracapsular extension (ECE), or more than two lymph node metastases) or they will undergo TORS (no extracapsular exension and maximally two lymph node metastases).
For patients with clinically no evidence of lymph node metastasis (cN0), neck dissection can be performed either before (within 8 days) or concurrently (same day procedure) with TORS.
Indications for adjuvant radiotherapy:
Nodal site:
- More than two lymph node metastases
- Two lymph node metastases and both above 1 cm in diameter.
- Any pathological positive lymph nodes (pN+) with extracapsular extension (ECE)
- A neck dissection nodal yield of less than 10 lymph nodes per side (after total embedding of the remaining fat tissue)
Tumour site:
- Involved or close resection margins of < 2 mm if free margins was not obtained after supplementary resections per-operatively or after re-resection in a secondary procedure.
- In case of stage migration to tumour stages T3 or T4, in an otherwise radical operation (R0), adjuvant therapy will be offered based on a postoperative consultation between the patient, the surgeon and an oncologist.
Indications for adjuvant chemotherapy:
- Insufficient resection margin (<2mm) or ECE
Specifics for the control arm:
Radiotherapy Quality Assurance Reviews are aimed to be performed before the third treatment fraction by a team from another head-neck oncology center consisting of one physicist and one oncologist. The patient specific review will address the following points according to the DAHANCA guideline: Clinical Target Volume (CTV) and Organs-at-Risk (OAR) delineation, target dose coverage, OAR dose sparing and treatment length.
Funding: The study protocol was initiated by the Department of Otorhinolaryngology, Head \& Neck surgery at Copenhagen University Hospital Rigshospitalet. Funding grants have been received by the Danish Health Authority ("Midler til eksperimentel kræftkirurgi"), by the Copenhagen University Hospital Rigshospitalet ("Rammebevilling") and Odense University Hospital ("Forskningspulje mellem OUH og RH").
Data management and ethical considerations: Data is stored and handled in accordance with the Danish Data Agency regulations, The General Data Protection Regulation (GDPR) 2016/679 in European Union (EU) law on data protection and privacy for all individual citizens of the EU and the European Economic Area (EEA), and in compliance with the national data agreement between the study locations in compliance with the Danish Data Protection Agency approval (ID: RH-2017-362).
During the trial, the Good Clinical Practice (GCP) unit in Aarhus will monitor the study trial according to the given protocol and the current legislation. The monitoring period will consist of the first 12 months of inclusion until the primary endpoint.
This study has been approved by the Regional Committee on Health Research Ethics (ID: H-17031827)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transoral robotic surgery (TORS) | Experimental | Procedure: Transoral Robotic Surgery (TORS) with neck dissection |
| Intensity-Modulated Radiation Therapy (IMRT) | Active comparator | Radiation: Intensity-Modulated Radiation Therapy (IMRT), Drug: Cisplatin, Drug: Nimorazole.Patients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensity-Modulated Radiation Therapy (IMRT)Accelerated or hyper-fractionated radiotherapy | Radiation | Intensity-Modulated Radiation Therapy (IMRT) |
| CisplatinConcurrent weekly cisplatin 40 mg/sqm to fit patients | Drug | Intensity-Modulated Radiation Therapy (IMRT) |
| Nimorazole.Concurrent nimorazole | Drug | Intensity-Modulated Radiation Therapy (IMRT) |
| Transoral Robotic Surgery (TORS) with neck dissectionRobotic-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. | Procedure or surgery | Transoral robotic surgery (TORS) |
Primary outcome
Swallowing related quality of life by MDADI
Time frame: evaluated at baseline, 3 and 12 months after treatment
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).
16 secondary outcomes
Nasogastric or percutaneus tube dependency
Time frame: evaluated at baseline, 3 and 12 months after treatment
Swallowing function by fiberendoscopic evaluation
Time frame: evaluated at baseline, 3 and 12 months after treatment
Swallowing function by modified barium swallowing
Time frame: evaluated at baseline, 3 and 12 months after treatment
Patient reported quality of life by EORTC-QLQ-H&N35
Time frame: evaluated at baseline, 3 and 12 months after treatment
Patient reported quality of life by EORTC QLQ-C30
Time frame: evaluated at baseline, 3 and 12 months after treatment
Treatment-related pain
Time frame: evaluated at baseline up to 12 months after treatment
Weight
Time frame: evaluated at baseline, 3 and 12 months after treatment
Patients returning to work after treatment
Time frame: evaluated at baseline, 3 and 12 months after treatment
Morbidity after staging neck after staging neck dissection
Time frame: evaluated from time of neck dissection up to 14 days after treatment
Nerve function
Time frame: evaluated at baseline and up to 12 months after treatment
Late toxicity
Time frame: evaluated at 3, 6, 12, 24, 36, 48 and 60 months after treatment
Overall survival
Time frame: evaluated from time of randomization up to 5 years
Disease-free survival
Time frame: evaluated from time of randomization up to 5 years
Disease-specific survival
Time frame: evaluated from time of randomization up to 5 years
Distant recurrence
Time frame: evaluated from time of randomization up to 5 years
Loco-regional recurrence
Time frame: evaluated from time of randomization up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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RecruitingObservational study
Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome
Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Oropharynx
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian von Buchwald, MD, DMSc. study chair
Department of Otorhinolaryngology, Head and Neck Surgery, Copenhagen University Hospital Rigshospitalet
Niclas Rubek, MD principal investigator
Department of Otorhinolaryngology, Head and Neck Surgery, Copenhagen University Hospital Rigshospitalet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensity-Modulated Radiation Therapy (IMRT), Cisplatin and Nimorazole. in people with Oropharynx Cancer and Oropharynx Squamous Cell Carcinoma, run by Christian von Buchwald at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swallowing related quality of life by MDADI (time frame: evaluated at baseline, 3 and 12 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.