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| Name | Class |
|---|---|
| The Novo Nordic Foundation | OTHER |
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Patients with squamous cell carcinoma of the pharynx or larynx and an anticipated benefit of proton radiotherapy in reducing the risk of late dysphagia or xerostomia are randomized to proton or photon radiotherapy (2:1)
DAHANCA 35 is two parallel conducted, but separate randomized studies, within the same trial (DAHANCA 35D and DAHANCA 35X) by the Danish Head-Neck Cancer Study Group (DAHANCA). In patients with squamous cell carcinoma of the pharynx or larynx planned for primary radiotherapy a proton and a photon doseplan is prepared. If proton radiotherapy reduces the anticipated absolute risk of dysphagia >= grade 2 (DAHANCA scale, DAHANCA 35D) or severe xerostomia >= grade 4 (EORTC Head-Neck 35, DAHANCA 35X) more than 5%, the patient is randomised to either proton therapy or photon therapy, 2:1. The anticipated risk of xerostomia and dysphagia is estimated using Normal-Tissue Complication Models (NTCP). Patient are analysed according to the primary endpoint (dysphagia and/or xerostomia) after which they were enrolled. DAHANCA 35D is expected to enroll 360 patients and DAHANCA 35X 240 patients (in total 600 patients).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton radiotherapy | Experimental | Proton radiotherapy according to the guidelines defined by the Danish Head-Neck Cancer Group (DAHANCA). Treatment: 66-68 Gy/ 33-34 fx/ 6/W, with cisplatin 40 mg/m2/W and nimorazole to suitable patients |
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| Photon radiotherapy | Active Comparator | Photon radiotherapy according to the guidelines defined by the Danish Head-Neck Cancer Group (DAHANCA). Treatment: 66-68 Gy/ 33-34 fx/ 6/W, with cisplatin 40 mg/m2/W and nimorazole to suitable patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton radiotherapy | Radiation | Proton radiotherapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Dysphagia >= grade 2 | The rate of observer-reported dysphagia >= grade 2 measured by the DAHANCA late toxicity score (grade 0-4, with 0 being best) | Six months after end of radiotherapy |
| Xerostomia = grade 4 | The rate of patient-reported xerostomia measured by the EORTC Quality of life questionnaire (QLQ) Head-Neck (HN) 35 (grade 1-4, with 1 being best) | Six months after end of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Loco-regional tumor control | Time to event of local-regional failure, from date of randomization to the date of first documented loco-regional failure. Rates are estimated by the Kaplan-Meier method. Interim analyses after 100, 200 and 300 patients. Will not be reported before the primary endpoint. | Up to five years after end of radiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeppe Friborg, MD, PhD | Contact | +45 35458189 | jeppe.friborg@regionh.dk | |
| Kenneth Jensen, MD, PhD | Contact | +45 78456400 | kennjens@rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| Jeppe Friborg, MD, PhD | Danish Head-Neck Cancer Group (DAHANCA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Recruiting | Aalborg | Denmark |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Randomized clinical trial
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| Photon radiotherapy |
| Radiation |
Photon radiotherapy |
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| Overall survival | From date of randomisation to date of death | Up to five years after end of radiotherapy |
| Number of participants with disease-free survival | From date of randomization to date of death (all causes), loco-regional failure or distant failure, whichever comes first | Up to five years after end of radiotherapy |
| Disease-specific survival | From date of randomization to date of death (by loco-regional or distant failure) | Up to five years after end of radiotherapy |
| Acute toxicity | DAHANCA acute toxicity score (grade 0-4, 0 being best) | From the beginning of and up to two months after end of radiotherapy |
| Late toxicity | DAHANCA late toxicity score (grade 0-4, 0 being best) | From two months to five years after end of radiotherapy |
| EORTC QLQ-Head-Neck 35 | Swallowing and social-eating scale and specific HN35 items related to eating and pain (grade 1-4, 1 being best) | Up to ten years after end of radiotherapy |
| EORTC C30 | Specific C30 items related to fatigue, nausea and vomiting (grade 1-4, 1 being best) | Up to ten years after end of radiotherapy |
| MD Anderson Dysphagia Index | MD Anderson Dysphagia Index (MDADI) (grade 1-5, 1 being best) | Up to ten years after end of radiotherapy |
| EuroQol Five Dimension Scale (EQ-5D) | Quality-adjusted life-years | Up to ten years after end of radiotherapy |
| Composite time corrected toxicity score (CTCT) | The sum of the time corrected dysphagia score and the time corrected xerostomia score normalised to maximum score across all days using EORTC QLQ-Head-Neck 35. The measure is unit-less. | Up to five years after end of radiotherapy |
| Modified barium swallowing | Functional swallowing test - DIGEST scale (grade 0-4, 0 being best) | One year after end of radiotherapy |
| Stimulated whole-mouth salivary flow | Stimulated whole-mouth salivary flow | Up to five years after end of radiotherapy |
| Aarhus University Hospital | Recruiting | Aarhus | Denmark |
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| Danish Center for Particle Therapy | Recruiting | Aarhus | Denmark |
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| Herlev Hospital | Recruiting | Copenhagen | Denmark |
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| Rigshospitalet | Recruiting | Copenhagen | Denmark |
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| Næstved Hospital | Recruiting | Næstved | Denmark |
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| Odense University Hospital | Recruiting | Odense | Denmark |
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