NCT07210749尚未招募不适用
A Phase II Trial Assessing 12 Gy in 6 Fractions Radiotherapy for Low-Grade B-cell Orbital Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Assess 2-year orbital LC after 12 Gy in 6 fractions.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Assess 2-year orbital LC after 12 Gy in 6 fractions.
时间窗: 24 Months after Treatment
次要结局
- Response rates (complete/partial/minimal response, stable/progressive disease)(6 months and 12 months after treatment)
- Evaluate orbital local control(5 years after treatment)
- Assess freedom from further in-field RT (FFRT), freedom from distant relapse (FFDR) and overall survival (OS)(2 year and 5 year after treatment)
- Health-Related Quality of Life using the EORTC QLQ-C30(5 years after treatment)
- Ocular Toxicity per CTCAE (5.0)(2 year and 5 year after treatment)
研究者
Matthew Chan
Principal Investigator (Co-PI)
British Columbia Cancer Agency
研究点 (2)
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