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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12 Gy in 6 fractions of external beam radiation therapy | Experimental | 12 Gy in 6 fractions of conventional external beam radiation therapy using standard-of-care radiation volumes for low-grade orbital lymphoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External Beam Radiation Therapy | Radiation | 12 Gy in 6 fractions of external beam radiation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess 2-year orbital LC after 12 Gy in 6 fractions. | 24 Months after Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Response rates (complete/partial/minimal response, stable/progressive disease) | 6 months and 12 months after treatment | |
| Evaluate orbital local control | 5 years after treatment | |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandy Chang | Contact | 604-675-4100 | 202199 | sandy.chang@bccancer.bc.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Cancer Vancouver | Vancouver | British Columbia | V5Z4E6 | Canada |
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| ID | Term |
|---|---|
| C537131 | Orbital lymphoma |
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12 Gy in 6 fractions external beam radiotherapy using standard-of-care radiation volumes for low-grade orbital lymphoma.
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| 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 | 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) | 5 years after treatment |
| Ocular Toxicity per CTCAE (5.0) | 2 year and 5 year after treatment |