Feasibility of Patient Selection and Treatment of Head-neck Cancer With Proton Therapy in Denmark

Not Applicable

Active, not recruiting

• Conditions: Head-and-neck Cancer
• Interventions: Other: Proton radiotherapy

• Registration Number: NCT05423704
• Lead Sponsor: Danish Head and Neck Cancer Group

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.

Study Timeline

• Study Start: 2019-05-20
• Primary Completion: 2021-11-14
• Status Verified: 2022-06
• Study First Submitted: 2022-06-07
• Study First Submitted QC: 2022-06-15
• Last Update Submitted: 2022-06-15
• Study First Posted: 2022-06-21
• Last Update Posted: 2022-06-21
• Study Completion: 2026-05-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 63

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Proton radiotherapy	Proton 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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Overall survival	Up to five years after end of radiotherapy]	From date of randomisation to date of death
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
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 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)

Trial Locations

Locations (7)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Herlev Hospital; 🇩🇰 Herlev, Denmark

Danish Center for Particle Therapy; 🇩🇰 Aarhus, Denmark

Næstved Hospital; 🇩🇰 Næstved, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark