Head-and-neck Cancer
Conditions
Keywords
Proton radiotherapy
Brief summary
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.
Detailed description
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.
Interventions
OTHERProton radiotherapy
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
Sponsors
Danish Head and Neck Cancer Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single group feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with histologically proven squamous cell carcinoma of the pharynx or larynx planned for primary radiotherapy with curative intent A predicted clinical significant reduction in the risk of any of the two primary endpoints (\>= grade 2 observer-rated dysphagia or grade 2 patient-reported xerostomia) after proton therapy compared to photon therapy based on comparison of the individual patient dose plans No current or earlier malignancies, which may influence treatment, evaluation or outcome of the head-neck cancer Informed consent as required by law Above 18 years of age
Exclusion criteria
Patient with cancers of the glottic larynx (stage I/II), skull base, sino-nasal area, nasopharynx, unknown primary tumor and prior malignancies. Patients with contraindications for proton therapy (as per 2019 pacemakers, implanted defibrillators and tracheostomy) Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic Distant metastasis Previous radiotherapy of the head and neck Previous surgery for the primary cancer with curative intent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dysphagia >= grade 2 | Six months after end of radiotherapy | The rate of observer-reported dysphagia \>= grade 2 measured by the DAHANCA late toxicity score (grade 0-4, with 0 being best) |
| Xerostomia = grade 2 | Six months after end of radiotherapy | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute toxicity | From the beginning of and up to two months after end of radiotherapy] | DAHANCA acute toxicity score (grade 0-4, 0 being best) |
| Late toxicity | From two months to five years after end of radiotherapy] | DAHANCA late toxicity score (grade 0-4, 0 being best) |
| Loco-regional tumor control | Up to five years after end of radiotherapy | 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. |
| EORTC C30 | Up to five years after end of radiotherapy] | Specific C30 items related to fatigue, nausea and vomiting (grade 1-4, 1 being best) |
| Time from referral to treatment | From date of referral to proton treatment to first proton treatment (Assessed up to 60 days) | Time from referral to proton center to first proton treatment |
| EORTC QLQ-Head-Neck 35 | Up to five years after end of radiotherapy | Swallowing and social-eating scale and specific HN35 items related to eating and pain (grade 1-4, 1 being best) |
| Overall survival | Up to five years after end of radiotherapy] | From date of randomisation to date of death |
Countries
Denmark
Outcome results
None listed