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

Официальное название

PRORADNOR-RCT Proton Versus Photon Therapy in Head and Neck Squamous Cell Carcinomas. A Randomised, Multicentre, Phase III Clinical Trial.

Обзор

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.

Вмешательства

• Лучевая терапия Proton Radiotherapy
  Proton versus Photon

Первичные конечные точки

• 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. [Срок оценки: 12 Months]

Вторичные конечные точки (5)

• Time from date of randomisation to date of loco-regional failure, distant metastasis or death from all causes, whichever comes first. [Срок оценки: 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. [Срок оценки: 12 Months]
• Time from date of randomisation to date of death (all causes). [Срок оценки: 10 Years]
• The combined toxicity burden of dysphagia, xerostomia, pain and speech measured with QLQ-H&N43 5 years after treatment. [Срок оценки: 5 Years]
• Time from date of randomisation to the first documented loco-regional failure. [Срок оценки: 3 Years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Норвегия · 4 центра

• Haukeland University Hospital — Bergen
• Oslo University Hospital, Radiumhospitalet — Oslo
• University Hospital of Northern Norway — Tromsø
• St. Olavs Hospital — Trondheim

Идентификаторы

NCT: NCT07580300 · 912158

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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