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Radiotherapy 12Gy in 6 Fractions For Orbital Lymphoma | Clinical Trials | Clareo Health

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Radiotherapy 12Gy in 6 Fractions For Orbital Lymphoma

A Phase II Trial Assessing 12 Gy in 6 Fractions Radiotherapy for Low-Grade B-cell Orbital Lymphoma

NCT07210749•British Columbia Cancer Agency

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

BC Cancer Vancouver

Vancouver, British Columbia, Canada

Key Dates

Start Date

November 1, 2025

Primary Completion Date

August 31, 2035

Completion Date

August 31, 2036

Last Updated

October 7, 2025

Enrollment

ESTIMATED participants

Conditions

Orbital Lymphoma

Interventions

External Beam Radiation Therapy

RADIATION

Contacts

Sandy Chang

CONTACT

604-675-4100 sandy.chang@bccancer.bc.ca