- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04607694
DAHANCA 35: Proton Versus Photon Therapy for Head-neck Cancer (DAHANCA 35)
October 23, 2020 updated by: Danish Head and Neck Cancer Group
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)
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Anticipated)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jeppe Friborg, MD, PhD
- Phone Number: +45 35458189
- Email: jeppe.friborg@regionh.dk
Study Contact Backup
- Name: Kenneth Jensen, MD, PhD
- Phone Number: +45 78456400
- Email: kennjens@rm.dk
Study Locations
-
-
-
Aalborg, Denmark
- Recruiting
- Aalborg University Hospital
-
Contact:
- Maria Andersen, MD
-
Contact:
- Martin S Nielsen, MSc
-
Aarhus, Denmark
- Recruiting
- Aarhus University Hospital
-
Contact:
- Jesper Eriksen, MD, PhD
-
Contact:
- Jørgen BB Petersen, MSc
-
Aarhus, Denmark
- Recruiting
- Danish Center for Particle Therapy
-
Contact:
- Kenneth Jensen, MD, PhD
-
Copenhagen, Denmark
- Recruiting
- Rigshospitalet
-
Contact:
- Jeppe Friborg, MD, PhD
-
Contact:
- Bob Smulders, MSc
-
Copenhagen, Denmark
- Recruiting
- Herlev Hospital
-
Contact:
- Elo Andersen, MD
-
Næstved, Denmark
- Recruiting
- Næstved Hospital
-
Contact:
- Mohammad Farhadi, MD
-
Contact:
- Eva Samsøe, MSc, PhD
-
Odense, Denmark
- Recruiting
- Odense University Hospital
-
Contact:
- Jørgen Johansen, MD, PhD
-
Contact:
- Christian R Hansen, MSc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
Proton radiotherapy
|
Active Comparator: 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
|
Photon radiotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Six months after end of radiotherapy
|
Xerostomia = grade 4
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)
|
Six months after end of radiotherapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Loco-regional tumor control
Time Frame: Up to five years after end of radiotherapy
|
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.
|
Up to five years after end of radiotherapy
|
Overall survival
Time Frame: Up to five years after end of radiotherapy
|
From date of randomisation to date of death
|
Up to five years after end of radiotherapy
|
Number of participants with disease-free survival
Time Frame: Up to five years after end of radiotherapy
|
From date of randomization to date of death (all causes), loco-regional failure or distant failure, whichever comes first
|
Up to five years after end of radiotherapy
|
Disease-specific survival
Time Frame: Up to five years after end of radiotherapy
|
From date of randomization to date of death (by loco-regional or distant failure)
|
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
|
DAHANCA acute toxicity score (grade 0-4, 0 being best)
|
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
|
DAHANCA late toxicity score (grade 0-4, 0 being best)
|
From two months to five years after end of radiotherapy
|
EORTC QLQ-Head-Neck 35
Time Frame: Up to ten years after end of radiotherapy
|
Swallowing and social-eating scale and specific HN35 items related to eating and pain (grade 1-4, 1 being best)
|
Up to ten years after end of radiotherapy
|
EORTC C30
Time Frame: Up to ten years after end of radiotherapy
|
Specific C30 items related to fatigue, nausea and vomiting (grade 1-4, 1 being best)
|
Up to ten years after end of radiotherapy
|
MD Anderson Dysphagia Index
Time Frame: Up to ten years after end of radiotherapy
|
MD Anderson Dysphagia Index (MDADI) (grade 1-5, 1 being best)
|
Up to ten years after end of radiotherapy
|
EuroQol Five Dimension Scale (EQ-5D)
Time Frame: Up to ten years after end of radiotherapy
|
Quality-adjusted life-years
|
Up to ten years after end of radiotherapy
|
Composite time corrected toxicity score (CTCT)
Time Frame: Up to five years after end of radiotherapy
|
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.
|
Up to five years after end of radiotherapy
|
Modified barium swallowing
Time Frame: One year after end of radiotherapy
|
Functional swallowing test - DIGEST scale (grade 0-4, 0 being best)
|
One year after end of radiotherapy
|
Stimulated whole-mouth salivary flow
Time Frame: Up to five years after end of radiotherapy
|
Stimulated whole-mouth salivary flow
|
Up to five years after end of radiotherapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jeppe Friborg, MD, PhD, Danish Head-Neck Cancer Group (DAHANCA)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 9, 2020
Primary Completion (Anticipated)
March 1, 2025
Study Completion (Anticipated)
September 1, 2025
Study Registration Dates
First Submitted
October 19, 2020
First Submitted That Met QC Criteria
October 23, 2020
First Posted (Actual)
October 29, 2020
Study Record Updates
Last Update Posted (Actual)
October 29, 2020
Last Update Submitted That Met QC Criteria
October 23, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DAHANCA 35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Head-and-neck Cancer
-
Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
-
Assiut UniversityRecruitingHead and Neck Cancer | Head and Neck Neoplasms | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and NeckEgypt
-
Mayo ClinicRecruitingCancer Head Neck | Cancer Neck | Cancer, HeadUnited States
-
IRCCS Policlinico S. MatteoNestlé Health Science Spain; Akern SrlCompletedHead-neck CancerItaly
-
University of California, San FranciscoCompleted
-
Chinook Therapeutics, Inc. (formerly Aduro)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedHead And Neck CancerUnited States
-
National Cancer Institute (NCI)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
-
Radboud University Medical CenterUnknown
-
Centre Oscar LambretUnknownEpidermoid Head and Neck CancerFrance
Clinical Trials on Proton radiotherapy
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); Massachusetts General HospitalCompleted
-
Proton Collaborative GroupRecruitingBreast Cancer | Breast Neoplasm | Breast Tumor | Cancer of the BreastUnited States
-
Massachusetts General HospitalNational Cancer Institute (NCI); Dana-Farber Cancer InstituteActive, not recruitingAstrocytoma | Brain Tumor | Ependymoma | Ganglioglioma | Low Grade GliomaUnited States
-
Abramson Cancer Center of the University of PennsylvaniaCompleted
-
Washington University School of MedicineRecruitingMetastatic Cancer | Unresectable Solid TumorUnited States
-
Uppsala UniversityKarolinska University Hospital; Sahlgrenska University Hospital, Sweden; University... and other collaboratorsRecruitingArteriovenous Malformation | Central Nervous System TumourSweden
-
Proton Collaborative GroupActive, not recruitingBreast Cancer | Breast Neoplasm | Breast Tumor | Cancer of the BreastUnited States
-
Loma Linda UniversityActive, not recruiting
-
University of AarhusCentre Leon Berard; University College London Hospitals; Aarhus University Hospital and other collaboratorsRecruitingEsophageal Cancer | Radiotherapy | Proton Therapy | Side EffectUnited Kingdom, France, Belgium, Denmark, Germany, Italy, Netherlands, Switzerland
-
Umeå UniversityRegion VästerbottenRecruitingAnal Cancer Squamous CellSweden