A Phase II Trial Assessing 12 Gy in 6 Fractions Radiotherapy for Low-Grade B-cell Orbital Lymphoma
| Registry | NCT07210749 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 36 (Estimated) |
| Sponsor | British Columbia Cancer Agency (Other) |
| Conditions | Orbital Lymphoma |
| Interventions | External Beam Radiation Therapy (Radiation) |
| Dates | start 2026-12-01 (estimated), primary completion 2035-08-31 (estimated), completion 2036-08-31 (estimated), first posted 2025-10-07, last updated 2026-10-13 |
| Locations | 1 site in Canada |
Related Papers Related Patents Related Grants Related Experts
All trials for Orbital Lymphoma All trials of External Beam Radiation Therapy
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 12 Gy in 6 fractions of external beam radiation therapy | Experimental | Radiation: External Beam Radiation Therapy | 12 Gy in 6 fractions of conventional external beam radiation therapy using standard-of-care radiation volumes for low-grade orbital lymphoma |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| BC Cancer Vancouver | Vancouver, British Columbia | Canada |