PIRATES: Image-guided Hyper-fractioned Dose-escalation With Proton Therapy for Head and Neck Cancer

Официальное название

Proton Image-guided Radiation Assignment for Therapeutic Escalation Via Selection of Locally Advanced Head and Neck Cancer Patients

Обзор

In this study the safety \& feasibility of image-guided mid-treatment hyper-fractioned dose-escalation with proton therapy will be assessed for the treatment of locally advanced HPV-negative squamous cell oropharyngeal cancer

Подробное описание

For this study, the investigators propose a novel design to safely achieve tumor radiation dose escalation with proton therapy plus standard-of-care concomitant chemotherapy. Through mid-treatment image guidance, the tumor boost dose is determined; subsequently, only that GTV boost will receive a total dose of 80 Gy through hybrid hyperfractionation. This refers to twice-daily radiation in the last 15 fraction days. The combination of boost dose hyperfractionation and proton therapy is anticipated to prevent critical normal tissue damage within both the high- and intermediate-dose regions. This novel treatment approach aims to minimize critical toxicities while improving locoregional control for head and neck cancer patients who are at a higher risk of disease relapse.

Вмешательства

• Лучевая терапия Image guided hybrid hyper-fractioned dose escalation with proton therapy
  Radiation: Image-guided hybrid hyper-fractioned dose escalation with proton therapy The investigational radiation regime will be administered in a two-part schedule: * The first 4 weeks (i.e. first 20 fractions) of the radiation treatment of the pathological tumor will be according to the conventional clinical standard with proton therapy: 20x 2 Gy to the CTV70 and 20 x 1.55 Gy to the CTV54. * In week 4 (\~ fraction 16) GTV80 will be determined on conventional weekly CT and additional MR imagi

Первичные конечные точки

• Safety and feasibility [Срок оценки: Within 6 months after radiotherapy]

Вторичные конечные точки (5)

• Completing radiotherapy regimen [Срок оценки: End of radiotherapy]
• Completing chemotherapy regimen [Срок оценки: End of chemotherapy]
• Toxicity after chemoradiation [Срок оценки: At 6 months after chemoradiation]
• Tumor response rate [Срок оценки: All SFP time points (baseline, weekly during RT, 6 weeks, 6, 12, 18, 24 months after treatment]
• Disease-free, overall survival and time-weighted locoregional control [Срок оценки: All SFP time points (baseline, weekly during RT, 6 weeks, 6, 12, 18, 24 months after treatment]

Критерии участия

Критерии включения

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

• Biopsy proven diagnosis of squamous cell carcinoma originating in the oropharynx.
• Routine staging procedures, including CT of the head and neck region and chest, head and neck FDG-PET/CT and MRI (treatment planning allowed), and endoscopic evaluation when indicated.
• Negative for p16
• Locally advanced disease, specifically meeting all following criteria:

• Stage III-IV
• T-stage 2-4
• All N-stages (N0-3)
• M0
• Eligible for primary concurrent chemoradiation using conventionally fractionated radiotherapy 70 Gy combined with weekly cisplatin
• Eastern Cooperative Oncology Group (ECOG) performance score ≥2
• Age ≥18 years
• Written informed consent

Критерии исключения

A potential subject who meets any of the following criteria will be excluded from participation in this study; patients that:

• underwent definitive resection of their primary tumor or nodal disease, except for incisional or excisional biopsies.

received radiation therapy in the head and neck area in the past

• have no detectable tumor anymore at both the primary site and lymph nodes at week 4 in treatment, because there will not be a volume to boost.
• are unable or unwilling to give written, informed consent
• have contra-indications for chemotherapy. This is at the discretion of the treating medical oncologist.
• are unable to tolerate intravenous contrast for both CT and MRI, having an estimated GFR < 60 ml/min/1.73 m2 or any contraindications to gadolinium-based contrast agents.
• have any evidence of iron overload on pre-imaging laboratory studies.
• have other serious illnesses or medical conditions present at entry in the study, including (but not limited to): immunodeficiency virus (HIV) infection or other conditions of persistent immunodeficiency, neurologic or psychiatric disorders, active disseminated intravascular coagulation, unstable cardiac disease despite treatment or uncontrolled diabetes mellitus.
• Women who are pregnant or breast feeding

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• UMC Groningen — Groningen

Идентификаторы

NCT: NCT06446713 · 18646

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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