Proton Versus Photon Therapy in Head and Neck Squamous Cell Carcinomas.

NCT07580300 | Recruiting Phase 3

• 1 other identifier: 912158
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 4

Brief Summary

A national, randomized, clinical trial (phase III) investigating radiotherapy with protons compared with photons for patients with squamous cell carcinoma of the head and neck area eligible for radiotherapy, either radical or postoperative, with curative intent. Comparative dose plans with protons and photons will be prepared, and the probability of toxicity evaluated with NTCP models. Patients with presumed benefit from protons will be randomized 1:1 to treatment with protons or photons. The number of randomized participants will be 400. The primary endpoint is "combined toxicity burden" - dry mouth, difficulty swallowing, pain and affected speech in the period after the end of radiotherapy to 12 months after treatment.

Conditions

HNSCC

Keywords

HNSCC; Proton

Outcome Measures

Primary Outcomes (1)

• The combined burden of patient-reported dysphagia, xerostomia, pain and speech measured as the area under the curve (AUC) with EORTC QLQ-H&N43 at baseline, end of treatment, 3-, 6- and 12-months following radiotherapy.

  12 Months

Secondary Outcomes (5)

• Time from date of randomisation to date of loco-regional failure, distant metastasis or death from all causes, whichever comes first.

  10 Years

• Occurrence of at least one event grade 2 toxicity as defined by CTCAE v5.0 at 12 months.Occurrence of at least one event grade 3 toxicity as defined by CTCAE v5.0 at 12 months.Occurrence of at least one event grade 4 toxicity as defined by CTCAE v5.0.

  12 Months

• Time from date of randomisation to date of death (all causes).

  10 Years

• The combined toxicity burden of dysphagia, xerostomia, pain and speech measured with QLQ-H&N43 5 years after treatment.

  5 Years

• Time from date of randomisation to the first documented loco-regional failure.

  3 Years

Study Arms (2)

Proton, Radiotherapy

EXPERIMENTAL

Radiation: Proton Radiotherapy

Photon, Radiotherapy

ACTIVE COMPARATOR

Radiation: Proton Radiotherapy

Interventions

Proton Radiotherapy RADIATION

Proton versus Photon

Photon, Radiotherapy; Proton, Radiotherapy

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Age ≥ 40 years.
• Histological or cytological verified squamous cell carcinoma of the following head and neck regions; oral cavity, oropharynx, hypopharynx or larynx.
• Planned for standard radiotherapy with curative intent, either as definitive or postoperative treatment with or without concomitant chemotherapy (cisplatin).
• ECOG performance status 0-2.
• Ability to fill in patient questionnaires and comply with study procedures.
• Able to answer questionnaires in Norwegian or English.
• Willing to travel to Oslo or Bergen for proton therapy if randomised to experimental arm.

You may not qualify if:

• Glottic cancers, cT1-T2 cN0 cM0.
• Nasopharyngeal carcinomas, sino-nasal cancers, and head and neck salivary gland carcinomas.
• Distant metastasis.
• Previous radiotherapy to the head and neck.
• Patients with pacemakers and/or implanted defibrillators.
• Prior malignancy within the last 5 years. Not including radically resected non-melanoma skin cancer or low-risk early-stage prostate cancer.
• Not able to participate due to equipment restrictions (weight limit treatment board 150 kg).
• Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could, at the investigator's opinion, interfere with the participant's safety or study participation.

Sponsors & Collaborators

• Oslo University Hospital: lead
• Klinbeforsk: collaborator
• South-Eastern Norway Regional Health Authority: collaborator

Study Sites (4)

Haukeland University Hospital

Bergen, 5051, Norway

NOT YET RECRUITING

Oslo University Hospital, Radiumhospitalet

Oslo, 0379, Norway

RECRUITING

University Hospital of Northern Norway

Tromsø, 9038, Norway

NOT YET RECRUITING

St. Olavs Hospital

Trondheim, 7006, Norway

NOT YET RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Hanne Eide, MD PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbro Berggren, Cand.Scient

CONTACT

004722934000; barbbe@ous-hf.no

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participant randomized 1:1 to treatment with proton or photon radiotherapy

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: April 28, 2026
• Primary Completion (Estimated): April 28, 2030
• Study Completion (Estimated): April 28, 2055
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

NO (4)