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Идёт набор NCT06487403

HN-BIO 02: A Phase II Randomized Study of the Effects of Delayed Elective Radiotherapy on Head and Neck MRI and Immune Response Biomarkers

Без фазы С лечением Squamous Cell Carcinoma of Head and Neck

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Standard of care external beam radiotherapy (single integrated boost), Standard of care external beam radiotherapy (two-phase treatment).
Кому может быть актуально
Состояния в реестре: Squamous Cell Carcinoma of Head and Neck. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Обзор

This is a single centre prospective exploratory study of effects of radiation therapy on biomarker development in patients with newly diagnosed (head and neck squamous cell carcinoma) HNSCC receiving curative therapy. This research is part 2 of the HN-BIO study.

Подробное описание

This study will recruit up to 40 patients planned to receive curative (chemo) radiotherapy for (head and neck squamous cell carcinoma) HNSCC with primary tumor and/or involved lymph node suitable for repeat biopsy in clinic. After being informed about the study and potential risks, patients giving written informed consent will be randomized to receive conventional radiotherapy (single integrated boost or conventional two-phase at clinician discretion) or reversed two-phase treatment with delayed irradiation of elective nodal volumes. Patients will not be informed of their randomization result.

Patients in both arms will undergo a baseline functional magnetic resonance imaging (fMRI) scan and within 72 hours, when possible, a biopsy of the primary tumor +/- lymph node will be performed in an out-patient clinic. If a suitable biopsy has been recently performed as part of diagnostic work up the baseline biopsy on study will be omitted when possible. In week 2 of radiotherapy, patients will have a second fMRI scan and a paired biopsy within 72 hours of the scan, where possible. A further optional biopsy and paired fMRI scan in week 4 will be considered for patients who are tolerating therapy without \>G1 toxicities. 16-24 hours prior to each biopsy the patient will take oral pimonidazole. At the time of each biopsy a blood draw will be performed.

Вмешательства

  • Лучевая терапия Standard of care external beam radiotherapy (single integrated boost)
    70Gy in 35 fractions, 56 Gy in 35 fractions. Oral Pimonidazole 200 mg and 300 mg tablets.
  • Лучевая терапия Standard of care external beam radiotherapy (two-phase treatment)
    70Gy in 35 fractions, delayed 40 Gy in 20 fractions or 50 Gy in 25 fractions. Oral Pimonidazole 200 mg and 300 mg tablets.

Первичные конечные точки

  • Confirm feasibility of recruitment of HN patients for on treatment repeat biopsy of the primary tumor +/- neck nodes [Срок оценки: 7 weeks]
  • Change in fMRI during radiotherapy [Срок оценки: 7 weeks]
  • Assess changes in tumor microenvironment during differing radiotherapy scheduling via repeat biopsy. [Срок оценки: 7 weeks]
Вторичные конечные точки (1)
  • Validate novel and established fMRI imaging as predictive and prognostic radiotherapy biomarkers for HNSCC [Срок оценки: 7 weeks]

Критерии участия

Критерии включения

  • Age >/= 18 years
  • Histologically proven Head and Neck Squamous Cell carcinoma
  • Primary or nodal disease > 3cm for biomarker imaging
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Planned for curative surgery or (chemo)radiotherapy
  • Willingness to undergo repeat MRI imaging
  • Able to receive and understand verbal and written information regarding study and able to -give written informed consent
  • Adequate renal function: Calculated creatinine clearance >/= 30ml/min
  • Be able to lie comfortably on back for 1 hour

Критерии исключения

  • As judged by investigator evidence of systemic disease that makes unsuitable for study
  • Contra-indication for serial MRI scans
  • Previous solid tumor treated within last 5 years
  • Pregnancy
  • History of gadolinium contrast allergy
  • Non-reversible clotting abnormality

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

Канада · 1 центр
  • Princess Margaret Cancer Centre — Toronto

Идентификаторы

NCT: NCT06487403 · 24-5510

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗