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

Head-and-neck Cancer Clinical Trial

Official title:

DAHANCA Proton Feasibility Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05423704
• Other study ID #: DAHANCA proton feasibility
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: May 14, 2026

Study information

• Verified date: June 2022
• Source: Danish Head and Neck Cancer Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 63
• Est. completion date: May 14, 2026
• Est. primary completion date: November 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Head-and-neck Cancer

Intervention

Other:
• 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

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus
Denmark	Danish Center for Particle Therapy	Aarhus
Denmark	Rigshospitalet	Copenhagen
Denmark	Herlev Hospital	Herlev
Denmark	Næstved Hospital	Næstved
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Danish Head and Neck Cancer Group

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)	Six months after end of radiotherapy
Secondary	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
Secondary	Overall survival	From date of randomisation to date of death	Up to five years after end of radiotherapy]
Secondary	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]
Secondary	Late toxicity	DAHANCA late toxicity score (grade 0-4, 0 being best)	From two months to five years after end of radiotherapy]
Secondary	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 five years after end of radiotherapy
Secondary	EORTC C30	Specific C30 items related to fatigue, nausea and vomiting (grade 1-4, 1 being best)	Up to five years after end of radiotherapy]
Secondary	Time from referral to treatment	Time from referral to proton center to first proton treatment	From date of referral to proton treatment to first proton treatment (Assessed up to 60 days)