NCT04607694: DAHANCA 35

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

Status unknown NA Last updated 23 October 2020

What this trial tests

NA trial testing Proton radiotherapy in Head-and-neck Cancer in 600 participants. Status unknown.

Timeline

9 October 2020

Primary endpoint
1 March 2025

1 September 2025

Quick facts

Lead sponsor	Danish Head and Neck Cancer Group
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	600
Start date	9 October 2020
Primary completion	1 March 2025
Estimated completion	1 September 2025
Sites	7 locations across Denmark

Drugs / interventions tested

• Proton radiotherapy
• Photon radiotherapy

Conditions studied

• Head-and-neck Cancer — all drugs for Head-and-neck Cancer →

Sponsor

Danish Head and Neck Cancer Group

Who can join

18 and older, any sex, with Head-and-neck Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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)
• 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)

Sponsor's own description

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)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Proton versus photon radiation therapy: A clinical review.
   Chen Z, Dominello MM, Joiner MC, Burmeister JW. · · 2023 · cited 32× · PMID 37064131 · DOI 10.3389/fonc.2023.1133909
2. Considerations for study design in the DAHANCA 35 trial of protons versus photons for head and neck cancer.
   Friborg J, Jensen K, Eriksen JG, Samsøe E, et al · · 2024 · cited 14× · PMID 37871751 · DOI 10.1016/j.radonc.2023.109958
3. Statistical fundamentals on cancer research for clinicians: Working with your statisticians.
   Xu W, Huang SH, Su J, Gudi S, et al · · 2021 · cited 8× · PMID 33532634 · DOI 10.1016/j.ctro.2021.01.006
4. Current Status and Future Directions of Proton Therapy for Head and Neck Carcinoma.
   Lillo S, Mirandola A, Vai A, Camarda AM, et al · · 2024 · cited 7× · PMID 38893203 · DOI 10.3390/cancers16112085
5. Proton versus photon radiotherapy for patients with oropharyngeal cancer in the USA: a multicentre, randomised, open-label, non-inferiority phase 3 trial.
   Frank SJ, Busse PM, Lee JJ, Rosenthal DI, et al · · 2026 · cited 5× · PMID 41391462 · DOI 10.1016/s0140-6736(25)01962-2
6. Emerging Radiotherapy Technologies for Head and Neck Squamous Cell Carcinoma: Challenges and Opportunities in the Era of Immunotherapy.
   Kut C, Quon H, Chen XS. · · 2024 · cited 4× · PMID 39766050 · DOI 10.3390/cancers16244150
7. Methodologies to Increase the Level of Evidence of Real-life Proton Therapy in Head and Neck Tumors.
   Dionisi F, Widesott L, Van Vulpen M, Fuller CD, et al · · 2021 · cited 2× · PMID 34285959 · DOI 10.14338/ijpt-20-00051.1
8. Late dysphagia after changes in high-dose clinical tumour volume margin for head and neck cancer patients.
   Zukauskaite R, Eriksen JG, Johansen J, Samsøe E, et al · · 2025 · cited 1× · PMID 40968403 · DOI 10.2340/1651-226x.2025.43924