Neoplasms

All Conditions

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Cisplatin

Nimorazole

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

Proton radiotherapy

Photon radiotherapy

Jeppe Friborg, MD, PhD

Kenneth Jensen, MD, PhD

Maria Andersen, MD

Martin S Nielsen, MSc

Jesper Eriksen, MD, PhD

Jørgen BB Petersen, MSc

Elo Andersen, MD

Bob Smulders, MSc

Mohammad Farhadi, MD

Eva Samsøe, MSc, PhD

Jørgen Johansen, MD, PhD

Christian R Hansen, MSc

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)

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).

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

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

The rate of observer-reported dysphagia \>= grade 2 measured by the DAHANCA late toxicity score (grade 0-4, with 0 being best)

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 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.

From date of randomisation to date of death

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

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

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

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

Swallowing and social-eating scale and specific HN35 items related to eating and pain (grade 1-4, 1 being best)

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

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

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
DAHANCA 35: Proton Versus Photon Therapy for Head-neck Cancer	NCT04607694	Head-and-neck C...	Proton radiothe... Photon radiothe...	18 Years -	Danish Head and Neck Cancer Group
DAHANCA 35: Proton Versus Photon Therapy for Head-neck Cancer	NCT04607694	Head-and-neck C...	Proton radiothe... Photon radiothe...	18 Years -	Danish Head and Neck Cancer Group

Spots Global Cancer Trial Database for dahanca

Every month we try and update this database with for dahanca cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for dahanca

Every month we try and update this database with for dahanca cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for dahanca cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.