Back to results

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

Primary Purpose

Head-and-neck Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Proton radiotherapy

Photon radiotherapy

About this trial

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

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 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

Sites / Locations

Aalborg University HospitalRecruiting
Aarhus University HospitalRecruiting
Danish Center for Particle TherapyRecruiting
Herlev HospitalRecruiting
RigshospitaletRecruiting
Næstved HospitalRecruiting
Odense University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Proton radiotherapy

Photon 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

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

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 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)

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

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

Disease-specific survival

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

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)

MD Anderson Dysphagia Index

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

EuroQol Five Dimension Scale (EQ-5D)

Quality-adjusted life-years

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.

Modified barium swallowing

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

Stimulated whole-mouth salivary flow

Full Information

NCT ID

NCT04607694

First Posted

October 19, 2020

Last Updated

October 23, 2020

Sponsor

Danish Head and Neck Cancer Group

Collaborators

The Novo Nordic Foundation

1. Study Identification

Unique Protocol Identification Number

NCT04607694

Brief Title

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

Acronym

DAHANCA 35

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Recruiting

Study Start Date

October 9, 2020 (Actual)

Primary Completion Date

March 2025 (Anticipated)

Study Completion Date

September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Danish Head and Neck Cancer Group

Collaborators

The Novo Nordic Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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)

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).

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, DAHANCA

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized clinical trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Proton radiotherapy

Arm Type

Experimental

Arm Description

Arm Title

Photon radiotherapy

Arm Type

Active Comparator

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Proton radiotherapy

Intervention Description

Proton radiotherapy

Intervention Type

Radiation

Intervention Name(s)

Photon radiotherapy

Intervention Description

Photon radiotherapy

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 4

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 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

Number of participants with disease-free survival

Description

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

Time Frame

Up to five years after end of radiotherapy

Title

Disease-specific survival

Description

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

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 ten 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 ten years after end of radiotherapy

Title

MD Anderson Dysphagia Index

Description

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

Time Frame

Up to ten years after end of radiotherapy

Title

EuroQol Five Dimension Scale (EQ-5D)

Description

Quality-adjusted life-years

Time Frame

Up to ten years after end of radiotherapy

Title

Composite time corrected toxicity score (CTCT)

Description

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.

Time Frame

Up to five years after end of radiotherapy

Title

Modified barium swallowing

Description

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

Time Frame

One year after end of radiotherapy

Title

Stimulated whole-mouth salivary flow

Description

Stimulated whole-mouth salivary flow

Time Frame

Up to five years after end of radiotherapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jeppe Friborg, MD, PhD

Phone

+45 35458189

jeppe.friborg@regionh.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Kenneth Jensen, MD, PhD

Phone

+45 78456400

kennjens@rm.dk

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

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Andersen, MD

First Name & Middle Initial & Last Name & Degree

Martin S Nielsen, MSc

Facility Name

Aarhus University Hospital

City

Aarhus

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jesper Eriksen, MD, PhD

First Name & Middle Initial & Last Name & Degree

Jørgen BB Petersen, MSc

Facility Name

Danish Center for Particle Therapy

City

Aarhus

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kenneth Jensen, MD, PhD

Facility Name

Herlev Hospital

City

Copenhagen

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elo Andersen, MD

Facility Name

Rigshospitalet

City

Copenhagen

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jeppe Friborg, MD, PhD

First Name & Middle Initial & Last Name & Degree

Bob Smulders, MSc

Facility Name

Næstved Hospital

City

Næstved

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohammad Farhadi, MD

First Name & Middle Initial & Last Name & Degree

Eva Samsøe, MSc, PhD

Facility Name

Odense University Hospital

City

Odense

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jørgen Johansen, MD, PhD

First Name & Middle Initial & Last Name & Degree

Christian R Hansen, MSc

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs