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

NCT ID: NCT04607694

Last Updated: 2020-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-09

Study Completion Date

2025-09-30

Brief Summary

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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)

Detailed Description

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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).

Conditions

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Head-and-neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Proton radiotherapy

Intervention Type RADIATION

Proton radiotherapy

Photon radiotherapy

Photon 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

Group Type ACTIVE_COMPARATOR

Photon radiotherapy

Intervention Type RADIATION

Photon radiotherapy

Interventions

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Proton radiotherapy

Proton radiotherapy

Intervention Type RADIATION

Photon radiotherapy

Photon radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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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 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Novo Nordic Foundation

OTHER

Sponsor Role collaborator

Danish Head and Neck Cancer Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeppe Friborg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Danish Head-Neck Cancer Group (DAHANCA)

Locations

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Aalborg University Hospital

Aalborg, , Denmark

Site Status RECRUITING

Aarhus University Hospital

Aarhus, , Denmark

Site Status RECRUITING

Danish Center for Particle Therapy

Aarhus, , Denmark

Site Status RECRUITING

Herlev Hospital

Copenhagen, , Denmark

Site Status RECRUITING

Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Næstved Hospital

Næstved, , Denmark

Site Status RECRUITING

Odense University Hospital

Odense, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Jeppe Friborg, MD, PhD

Role: CONTACT

[email protected]
+45 35458189

Kenneth Jensen, MD, PhD

Role: CONTACT

[email protected]
+45 78456400

Facility Contacts

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Maria Andersen, MD

Role: primary

Martin S Nielsen, MSc

Role: backup

Jesper Eriksen, MD, PhD

Role: primary

Jørgen BB Petersen, MSc

Role: backup

Kenneth Jensen, MD, PhD

Role: primary

Elo Andersen, MD

Role: primary

Jeppe Friborg, MD, PhD

Role: primary

Bob Smulders, MSc

Role: backup

Mohammad Farhadi, MD

Role: primary

Eva Samsøe, MSc, PhD

Role: backup

Jørgen Johansen, MD, PhD

Role: primary

Christian R Hansen, MSc

Role: backup

Other Identifiers

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DAHANCA 35

Identifier Type: -

Identifier Source: org_study_id