An interventional study of Intensity-Modulated Radiation Therapy (IMRT) and Cisplatin in Oropharynx Cancer, Oropharynx Squamous Cell Carcinoma and Carcinoma, Squamous Cell, sponsored by Christian von Buchwald. Active, not recruiting at 3 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-31.
Sponsored by Christian von Buchwald · Not applicable, Interventional, and Treatment
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.
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:
Tumour site:
Indications for adjuvant chemotherapy:
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)
369 studies on the registry are indexed under Oropharyngeal Neoplasms; 103 are open to participants now.
This study's planned enrollment of 138 is above the median of 52 across 265 interventional studies indexed under Oropharyngeal Neoplasms.
Browse Oropharyngeal Neoplasms studies →Christian von Buchwald is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Transoral Robotic Surgery (TORS) with neck dissection
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.
Radiation: Intensity-Modulated Radiation Therapy (IMRT) · Drug: Cisplatin · Drug: Nimorazole.
Accelerated or hyper-fractionated radiotherapy
Concurrent weekly cisplatin 40 mg/sqm to fit patients
Concurrent nimorazole
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.
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).
Time frame: evaluated at baseline, 3 and 12 months after treatment
Nasogastric or percutaneus tube dependency
Tube dependency defined as number of days/weeks/months with tube inserted
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
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
Defined as the time (number of days) before returning to work or failure to do so after treatment.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: evaluated at 3, 6, 12, 24, 36, 48 and 60 months after treatment
Overall survival
Time from randomization to death from any cause.
Time frame: evaluated from time of randomization up to 5 years
Disease-free survival
Time from randomization to sign of cancer is found.
Time frame: evaluated from time of randomization up to 5 years
Disease-specific survival
Time from randomization to death from the disease (oropharyngeal cancer).
Time frame: evaluated from time of randomization up to 5 years
Distant recurrence
Time from randomization to distant recurrence
Time frame: 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
Time frame: evaluated from time of randomization up to 5 years
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Christian von Buchwald