Status:
NOT_YET_RECRUITING
Radiotherapy 12Gy in 6 Fractions For Orbital Lymphoma
Lead Sponsor:
British Columbia Cancer Agency
Conditions:
Orbital Lymphoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 fractio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2036
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT07210749
Start Date
November 1 2025
End Date
August 31 2036
Last Update
October 7 2025
Active Locations (1)
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1
BC Cancer Vancouver
Vancouver, British Columbia, Canada, V5Z4E6