Orbital Lymphoma
Conditions
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.
Interventions
RADIATIONExternal Beam Radiation Therapy
12 Gy in 6 fractions of external beam radiation therapy
Sponsors
British Columbia Cancer Agency
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
12 Gy in 6 fractions external beam radiotherapy using standard-of-care radiation volumes for low-grade orbital lymphoma.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess 2-year orbital LC after 12 Gy in 6 fractions. | 24 Months after Treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Canada
Contacts
Primary ContactSandy Chang
Outcome results
None listed