Radiotherapy 12Gy in 6 Fractions For Orbital Lymphoma
- Conditions
- Orbital Lymphoma
- Registration Number
- NCT07210749
- Lead Sponsor
- British Columbia Cancer Agency
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 36
-
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
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ECOG performance status 0-3
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Life expectancy >12 months
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Available for treatment and follow-up (including scheduled post-treatment imaging and ophthalmologic exam)
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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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Assess 2-year orbital LC after 12 Gy in 6 fractions. 24 Months after Treatment
- Secondary Outcome Measures
Name Time Method 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 The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) measures health-related quality of life through 5 functional, 9 symptom, and 1 global health status scale; minimum score = 0, maximum score = 100 (for functional scales, higher is better; for symptom scales, lower is better)
Ocular Toxicity per CTCAE (5.0) 2 year and 5 year after treatment
Trial Locations
- Locations (1)
BC Cancer Vancouver
🇨🇦Vancouver, British Columbia, Canada
BC Cancer Vancouver🇨🇦Vancouver, British Columbia, CanadaSandy ChangContact6048776000sandy.chang@bccancer.bc.ca