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

Phase 3RecruitingNCT07580300

Oslo University Hospital400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

HNSCC

Interventions

Eligibility

Sex: ALLMin age: 40 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Signed informed consent. 2. Age ≥ 40 years. 3. Histological or cytological verified squamous cell carcinoma of the following head and neck regions; oral cavity, oropharynx, hypopharynx or larynx. 4. Planned for standard radiotherapy with curative intent, either as definitive or postoperative treatment with or without concomitant chemotherapy (cisplatin). 5. ECOG performance status 0-2. 6. Ability to fill in patient questionnaires and comply with study procedures. 7. Able to answer questionnaires in Norwegian or English. 8. Willing to travel to Oslo or Bergen for proton therapy if randomised to experimental arm. Exclusion Criteria: 1. Glottic cancers, cT1-T2 cN0 cM0. 2. Nasopharyngeal carcinomas, sino-nasal cancers, and head and neck salivary gland carcinomas. 3. Distant metastasis. 4. Previous radiotherapy to the head and neck. 5. Patients with pacemakers and/or implanted defibrillators. 6. Prior malignancy within the last 5 years. Not including radically resected non-melanoma skin cancer or low-risk early-stage prostate cancer. 7. Not able to participate due to equipment restrictions (weight limit treatment board 150 kg). 8. 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.

Locations (4)

Haukeland University Hospital

Bergen, Norway

NOT_YET_RECRUITING

Oslo University Hospital, Radiumhospitalet

Oslo, Norway

RECRUITING

University Hospital of Northern Norway

Tromsø, Norway

NOT_YET_RECRUITING

St. Olavs Hospital

Trondheim, Norway

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 12 Months

Secondary Outcomes

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

Time frame: 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.

Time frame: 12 Months

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

Time frame: 10 Years

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

Toxicity burden measured with QLQ-H\&N43

Time frame: 5 Years

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

Time frame: 3 Years

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

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts