A study to investigate feasibility of local selection of patients with squamous cell carcinoma of the pharynx or larynx using anticipated benefit of proton radiotherapy in reducing the risk of late dysphagia or xerostomia.
In preparation for a randomised study in Denmark (DAHANCA 35) the feasibility of selecting newly diagnosed patients with squamous cell carcinoma of the pharynx or larynx for proton therapy at the local treatment centers is investigated. A proton and a photon doseplan is prepared for patients planned for primary radiotherapy . If proton radiotherapy reduces the anticipated absolute risk of dysphagia \>= grade 2 (DAHANCA scale and/or xerostomia \>= grade 2 (EORTC Head-Neck 35) with a clinical relevant value the patient is offered proton therapy at the Danish Center for Particle Therapy. The anticipated risk of xerostomia and dysphagia is estimated using Normal-Tissue Complication Models (NTCP). At least five patients from each of the six Danish centers are required in this feasibility study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
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
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Danish Center for Particle Therapy
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
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)
Time frame: Six months after end of radiotherapy
Xerostomia = grade 2
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)
Time frame: Six months after end of radiotherapy
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.
Time frame: Up to five years after end of radiotherapy
Overall survival
From date of randomisation to date of death
Time frame: Up to five years after end of radiotherapy]
Acute toxicity
DAHANCA acute toxicity score (grade 0-4, 0 being best)
Time frame: 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)
Time frame: 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)
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Herlev Hospital
Herlev, Denmark
Næstved Hospital
Næstved, Denmark
Odense University Hospital
Odense, Denmark
Time frame: Up to five years after end of radiotherapy
EORTC C30
Specific C30 items related to fatigue, nausea and vomiting (grade 1-4, 1 being best)
Time frame: Up to five years after end of radiotherapy]
Time from referral to treatment
Time from referral to proton center to first proton treatment
Time frame: From date of referral to proton treatment to first proton treatment (Assessed up to 60 days)