Radiotherapy 12Gy in 6 Fractions For Orbital Lymphoma

Официальное название

A Phase II Trial Assessing 12 Gy in 6 Fractions Radiotherapy for Low-Grade B-cell Orbital Lymphoma

Обзор

Current standard RT doses (24-25Gy) provide excellent disease control for patients with indolent B-cell orbital lymphoma, but can cause significant late toxicities. Ultra-low dose RT (4Gy in 2 fractions) has minimal toxicity but lower disease control, requiring intensive follow-up to salvage persistent tumors. Some centers are moving towards this dose as the new standard. A recent study using 12Gy in 4 fractions to any body site showed early data suggesting high disease control rates with minimal toxicity. This study assesses 12Gy in 6 fractions, aiming to enhance disease control over 4Gy while reducing toxicity compared to 24Gy.

Вмешательства

• Лучевая терапия External Beam Radiation Therapy
  12 Gy in 6 fractions of external beam radiation therapy

Первичные конечные точки

• Assess 2-year orbital LC after 12 Gy in 6 fractions. [Срок оценки: 24 Months after Treatment]

Вторичные конечные точки (5)

• Response rates (complete/partial/minimal response, stable/progressive disease) [Срок оценки: 6 months and 12 months after treatment]
• Evaluate orbital local control [Срок оценки: 5 years after treatment]
• Assess freedom from further in-field RT (FFRT), freedom from distant relapse (FFDR) and overall survival (OS) [Срок оценки: 2 year and 5 year after treatment]
• Health-Related Quality of Life using the EORTC QLQ-C30 [Срок оценки: 5 years after treatment]
• Ocular Toxicity per CTCAE (5.0) [Срок оценки: 2 year and 5 year after treatment]

Критерии участия

Критерии включения

• Age ≥18 years with stage I-IV indolent NHL\*
• Able to provide informed consent
• Histologically confirmed indolent NHL involving one or both orbits. If bilateral, biopsy of only one orbit is permitted as long as high clinical suspicion of contralateral orbit involvement
• Measurable orbital disease after biopsy, either clinically or radiographically
• ECOG performance status 0-3
• Life expectancy >12 months
• Available for treatment and follow-up (including scheduled post-treatment imaging and ophthalmologic exam)
• Able and willing to complete quality of life questionnaires via paper or online portal if they provide their email address on the informed consent document

• Stage II-IV allowed but if systemic therapy given after RT the timing will be recorded, and subjects will be stratified according to receipt of systemic therapy

Критерии исключения

• Aggressive NHL histology (including grade 3B follicular lymphoma)
• Prior RT to orbit
• Patients requiring treatments outside standard clinical hours
• Systemic therapy for lymphoma is not permitted within the period of time between 2 weeks prior to RT start and 2 weeks after RT completion
• Patients who are pregnant
• History of other malignancy within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death and/or treated with expected curative outcome (for example, appropriately treated non-melanoma skin cancer, carcinoma in-situ of the cervix, localized prostate cancer, breast ductal carcinoma in-situ, or stage I endometrial cancer)
• Any medical condition that, in the investigator's judgement, would preclude the individual's safe participation in and completion of the study, or could affect interpretation of the results (e.g. pre-existing retinopathy, active connective tissue disease)
• Inability to comply with study and follow-up procedures

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

Канада · 1 центр

• BC Cancer Vancouver — Vancouver

Идентификаторы

NCT: NCT07210749 · 12-OLY

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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