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

DAHANCA Proton Feasibility Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Head-and-neck Cancer
• Intervention / Treatment: Other: Proton radiotherapy

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 Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark
    • Aalborg University Hospital
  • Aarhus, Denmark
    • Aarhus University Hospital
  • Aarhus, Denmark
    • Danish Center for Particle Therapy
  • Copenhagen, Denmark
    • Rigshospitalet
  • Herlev, Denmark
    • Herlev Hospital
  • Næstved, Denmark
    • Næstved Hospital
  • Odense, Denmark
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 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 Outcome Measures

Outcome Measure	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
Overall survival	From date of randomisation to date of death	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 five years after end of radiotherapy
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]
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)

Collaborators and Investigators

• Sponsor: Danish Head and Neck Cancer Group
• Investigators: Principal Investigator: Jeppe Friborg, MD, PhD, Danish Head-Neck Cancer Group (DAHANCA)

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): November 14, 2021
• Study Completion (Anticipated): May 14, 2026

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Proton radiotherapy
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: DAHANCA proton feasibility

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No