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Head-and-neck CancerDAHANCA 35NCT04607694

DAHANCA 35: Proton Versus Photon Therapy for Head-neck Cancer

A study testing Proton radiotherapy and Photon radiotherapy in people with Head-and-neck Cancer, run by Danish Head and Neck Cancer Group at 7 sites in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Patients with squamous cell carcinoma of the pharynx or larynx and an anticipated benefit of proton radiotherapy in reducing the risk of late dysphagia or xerostomia are randomized to proton or photon radiotherapy (2:1) 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 and Photon radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
7 sitesDenmark
Study dates
9 Oct 2020to Sep 2025
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 4 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, unknown primary tumor and prior malignancies.
  • Patients with contraindications for proton therapy. Per October 2020, this includes 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.

Jeppe Friborg, MD, PhD contact

+45 35458189

jeppe.friborg@regionh.dk

Kenneth Jensen, MD, PhD contact

+45 78456400

kennjens@rm.dk

7 sites in 1 country

Denmark7 sites, 7 recruiting

  • Aalborg University Hospital

    Aalborg

    Maria Andersen, MD

    Martin S Nielsen, MSc

    Recruiting

  • Aarhus University Hospital

    Aarhus

    Jesper Eriksen, MD, PhD

    Jørgen BB Petersen, MSc

    Recruiting

  • Danish Center for Particle Therapy

    Aarhus

    Kenneth Jensen, MD, PhD

    Recruiting

  • Herlev Hospital

    Copenhagen

    Elo Andersen, MD

    Recruiting

  • Rigshospitalet

    Copenhagen

    Jeppe Friborg, MD, PhD

    Bob Smulders, MSc

    Recruiting

  • Næstved Hospital

    Næstved

    Mohammad Farhadi, MD

    Eva Samsøe, MSc, PhD

    Recruiting

  • Odense University Hospital

    Odense

    Jørgen Johansen, MD, PhD

    Christian R Hansen, MSc

    Recruiting

Other trials in Denmark

About this study

Official title: DAHANCA 35: A Randomized Trial of Proton Versus Photon Radiotherapy for the Treatment of Head-neck Cancer

Patients with squamous cell carcinoma of the pharynx or larynx and an anticipated benefit of proton radiotherapy in reducing the risk of late dysphagia or xerostomia are randomized to proton or photon radiotherapy (2:1)

Read the detailed description

DAHANCA 35 is two parallel conducted, but separate randomized studies, within the same trial (DAHANCA 35D and DAHANCA 35X) by the Danish Head-Neck Cancer Study Group (DAHANCA). In patients with squamous cell carcinoma of the pharynx or larynx planned for primary radiotherapy a proton and a photon doseplan is prepared. If proton radiotherapy reduces the anticipated absolute risk of dysphagia >= grade 2 (DAHANCA scale, DAHANCA 35D) or severe xerostomia >= grade 4 (EORTC Head-Neck 35, DAHANCA 35X) more than 5%, the patient is randomised to either proton therapy or photon therapy, 2:1. The anticipated risk of xerostomia and dysphagia is estimated using Normal-Tissue Complication Models (NTCP). Patient are analysed according to the primary endpoint (dysphagia and/or xerostomia) after which they were enrolled. DAHANCA 35D is expected to enroll 360 patients and DAHANCA 35X 240 patients (in total 600 patients).

Being tested
Proton radiotherapy, Photon radiotherapy
Keywords
Proton radiotherapy, DAHANCA
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 radiotherapyRadiation

    Proton radiotherapy

  • Photon radiotherapyRadiation

    Photon radiotherapy

Study groups in NCT04607694
Study groupRoleWhat they receive
Proton radiotherapyExperimentalProton 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: Radiation: Proton radiotherapy
Photon radiotherapyActive comparatorPhoton 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: Radiation: Photon radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. Xerostomia = grade 4

    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 (13)

  1. 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

  2. Overall survival

    From date of randomisation to date of death

    Measured: Up to five years after end of radiotherapy

  3. Number of participants with disease-free survival

    From date of randomization to date of death (all causes), loco-regional failure or distant failure, whichever comes first

    Measured: Up to five years after end of radiotherapy

  4. Disease-specific survival

    From date of randomization to date of death (by loco-regional or distant failure)

    Measured: Up to five years after end of radiotherapy

  5. 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

  6. Late toxicity

    DAHANCA late toxicity score (grade 0-4, 0 being best)

    Measured: From two months to five years after end of radiotherapy

  7. 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 ten years after end of radiotherapy

  8. EORTC C30

    Specific C30 items related to fatigue, nausea and vomiting (grade 1-4, 1 being best)

    Measured: Up to ten years after end of radiotherapy

  9. MD Anderson Dysphagia Index

    MD Anderson Dysphagia Index (MDADI) (grade 1-5, 1 being best)

    Measured: Up to ten years after end of radiotherapy

  10. EuroQol Five Dimension Scale (EQ-5D)

    Quality-adjusted life-years

    Measured: Up to ten years after end of radiotherapy

  11. Composite time corrected toxicity score (CTCT)

    The sum of the time corrected dysphagia score and the time corrected xerostomia score normalised to maximum score across all days using EORTC QLQ-Head-Neck 35. The measure is unit-less.

    Measured: Up to five years after end of radiotherapy

  12. Modified barium swallowing

    Functional swallowing test - DIGEST scale (grade 0-4, 0 being best)

    Measured: One year after end of radiotherapy

  13. Stimulated whole-mouth salivary flow

    Stimulated whole-mouth salivary flow

    Measured: Up to five years after end of radiotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2020
  2. Study start9 Oct 2020
  3. Primary completionMar 2025 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Randomized clinical trial
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04607694
Sponsor's protocol ID
DAHANCA 35
Acronym
DAHANCA 35
Status last verified
Oct 2020
First submitted
19 Oct 2020
Last updated
29 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Proton radiotherapy and Photon 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 29 Oct 2020. 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?

Contact Jeppe Friborg, MD, PhD (+45 35458189, jeppe.friborg@regionh.dk), or a site near the patient. 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?

On the ClinicalTrials.gov record for NCT04607694.

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 29 Oct 2020.

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