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

Primary Purpose

Head-and-neck Cancer

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Proton radiotherapy
Sponsored by
Danish Head and Neck Cancer Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head-and-neck Cancer focused on measuring Proton radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proton radiotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

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.
Overall survival
From date of randomisation to date of death
Acute toxicity
DAHANCA acute toxicity score (grade 0-4, 0 being best)
Late toxicity
DAHANCA late toxicity score (grade 0-4, 0 being best)
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)
EORTC C30
Specific C30 items related to fatigue, nausea and vomiting (grade 1-4, 1 being best)
Time from referral to treatment
Time from referral to proton center to first proton treatment

Full Information

First Posted
June 7, 2022
Last Updated
June 15, 2022
Sponsor
Danish Head and Neck Cancer Group
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1. Study Identification

Unique Protocol Identification Number
NCT05423704
Brief Title
Feasibility of Patient Selection and Treatment of Head-neck Cancer With Proton Therapy in Denmark
Official Title
DAHANCA Proton Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
November 14, 2021 (Actual)
Study Completion Date
May 14, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danish Head and Neck Cancer Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head-and-neck Cancer
Keywords
Proton radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group feasibility study
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proton radiotherapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Proton radiotherapy
Intervention Description
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 Measure Information:
Title
Dysphagia >= grade 2
Description
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
Title
Xerostomia = grade 2
Description
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
Secondary Outcome Measure Information:
Title
Loco-regional tumor control
Description
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
Title
Overall survival
Description
From date of randomisation to date of death
Time Frame
Up to five years after end of radiotherapy]
Title
Acute toxicity
Description
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]
Title
Late toxicity
Description
DAHANCA late toxicity score (grade 0-4, 0 being best)
Time Frame
From two months to five years after end of radiotherapy]
Title
EORTC QLQ-Head-Neck 35
Description
Swallowing and social-eating scale and specific HN35 items related to eating and pain (grade 1-4, 1 being best)
Time Frame
Up to five years after end of radiotherapy
Title
EORTC C30
Description
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]
Title
Time from referral to treatment
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeppe Friborg, MD, PhD
Organizational Affiliation
Danish Head-Neck Cancer Group (DAHANCA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
Country
Denmark
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
Facility Name
Danish Center for Particle Therapy
City
Aarhus
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Herlev Hospital
City
Herlev
Country
Denmark
Facility Name
Næstved Hospital
City
Næstved
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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