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

ConditionHNSCC
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-90
SponsorOslo University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Proton Radiotherapy

    Radiation

    Proton versus Photon

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Proton, RadiotherapyExperimental treatment 1 intervention
Group B: Photon, RadiotherapyActive comparator 1 intervention

Trial outcomes

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.

Time frame
12 Months

Secondary outcomes

1

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
2

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
3

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

Time frame
10 Years
4

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

Other outcomes

Sponsors and contacts

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Oslo University Hospital

Lead sponsor

Klinbeforsk

Collaborator

South-Eastern Norway Regional Health Authority

Collaborator

Source ClinicalTrials.gov
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