Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
36 participants
INTERVENTIONAL
2025-11-01
2036-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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12 Gy in 6 fractions of 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
External Beam Radiation Therapy
12 Gy in 6 fractions of external beam radiation therapy
Interventions
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External Beam Radiation Therapy
12 Gy in 6 fractions of external beam radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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British Columbia Cancer Agency
OTHER
Responsible Party
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Matthew Chan
Principal Investigator (Co-PI)
Locations
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BC Cancer Vancouver
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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12-OLY
Identifier Type: -
Identifier Source: org_study_id
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