Proton Versus Photon Therapy in Head and Neck Squamous Ce... | NCT07580300

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

NCT07580300

Sponsor

Oslo University Hospital

Status

Recruiting

Last Update Posted

May 15, 2026Actual

Enrollment

400Estimated

Phase

Phase 3

Conditions

HNSCC

Interventions

Proton Radiotherapy

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 28, 2026Actual

Primary Completion Date

Apr 28, 2030Estimated

Completion Date

Apr 28, 2055Estimated

First Submitted Date

May 6, 2026

First Submission Date that Met QC Criteria

May 6, 2026

First Posted Date

May 12, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2026

Last Update Posted Date

May 15, 2026Actual

Name	Class
Klinbeforsk	OTHER
South-Eastern Norway Regional Health Authority	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Proton, Radiotherapy	Experimental		Radiation: Proton Radiotherapy
Photon, Radiotherapy	Active Comparator		Radiation: Proton Radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Proton Radiotherapy	Radiation	Proton versus Photon	Photon, Radiotherapy Proton, Radiotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Barbro Berggren, Cand.Scient	Contact	004722934000		barbbe@ous-hf.no

Name	Affiliation	Role
Hanne Eide, MD PhD	Oslo University Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Haukeland University Hospital	Not yet recruiting	Bergen		5051	Norway

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000077195	Squamous Cell Carcinoma of Head and Neck

Ancestor Terms

ID	Term
D002294	Carcinoma, Squamous Cell
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided