Head-and-neck CancerNCT05423704
Feasibility of Patient Selection and Treatment of Head-neck Cancer With Proton Therapy in Denmark
A study testing Proton radiotherapy in people with Head-and-neck Cancer, run by Danish Head and Neck Cancer Group at 7 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head-and-neck Cancer
- What is being tested?
- Proton radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 7 sitesDenmark
- Study dates
- 20 May 2019to 14 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Denmark7 sites
Aalborg University Hospital
Aalborg
Aarhus University Hospital
Aarhus
Danish Center for Particle Therapy
Aarhus
Rigshospitalet
Copenhagen
Herlev Hospital
Herlev
Næstved Hospital
Næstved
Odense University Hospital
Odense
About this study
Official title: 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.
Read the 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.
- Conditions
- Head-and-neck Cancer
- Being tested
- Proton radiotherapy
- Keywords
- Proton radiotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton radiotherapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Proton radiotherapy | Experimental | 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 Receives: Other: Proton radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Six months after end of radiotherapy
Secondary outcomes (7)
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.
Measured: Up to five years after end of radiotherapy
Overall survival
From date of randomisation to date of death
Measured: Up to five years after end of radiotherapy]
Acute toxicity
DAHANCA acute toxicity score (grade 0-4, 0 being best)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Up to five years after end of radiotherapy]
Time from referral to treatment
Time from referral to proton center to first proton treatment
Measured: From date of referral to proton treatment to first proton treatment (Assessed up to 60 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start20 May 2019
- Primary completion14 Nov 2021
- Study completion14 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head-and-neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group feasibility study
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Head and Neck Cancer Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jeppe Friborg, MD, PhD, Principal investigator, Danish Head-Neck Cancer Group (DAHANCA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423704
- Sponsor's protocol ID
- DAHANCA proton feasibility
- Status last verified
- Jun 2022
- First submitted
- 7 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DAHANCA Proton Feasibility Study
- ClinicalTrials.gov ID
- NCT05423704
- Acronym / sponsor ID
- DAHANCA proton feasibility
- Conditions
- Head-and-neck Cancer
- Keywords
- Proton radiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Danish Head and Neck Cancer GroupResearch network
- Study start
- 20 May 2019 (actual)
- Primary completion
- 14 Nov 2021 (actual)
- Study completion
- 14 May 2026 (estimated)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group feasibility study
| Arm | Type | Receives |
|---|---|---|
| Proton radiotherapy | Experimental | Other: Proton radiotherapyProton 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton radiotherapyProton 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 |
Primary outcome
Dysphagia >= grade 2
Time frame: 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
Time frame: 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)
7 secondary outcomes
Loco-regional tumor control
Time frame: Up to five years after end of radiotherapy
Overall survival
Time frame: Up to five years after end of radiotherapy]
Acute toxicity
Time frame: From the beginning of and up to two months after end of radiotherapy]
Late toxicity
Time frame: From two months to five years after end of radiotherapy]
EORTC QLQ-Head-Neck 35
Time frame: Up to five years after end of radiotherapy
EORTC C30
Time frame: Up to five years after end of radiotherapy]
Time from referral to treatment
Time frame: From date of referral to proton treatment to first proton treatment (Assessed up to 60 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
Related trials for Head-and-neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeppe Friborg, MD, PhD principal investigator
Danish Head-Neck Cancer Group (DAHANCA)
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton radiotherapy in people with Head-and-neck Cancer, run by Danish Head and Neck Cancer Group at 7 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysphagia >= grade 2 (time frame: Six months after end of radiotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.