Radiotherapy 12Gy in 6 Fractions For Orbital Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: External Beam Radiation Therapy.
- Who it may be relevant to
- Registry conditions: Orbital Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase II Trial Assessing 12 Gy in 6 Fractions Radiotherapy for Low-Grade B-cell Orbital Lymphoma
Overview
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
- Radiation External Beam Radiation Therapy
12 Gy in 6 fractions of external beam radiation therapy
Primary outcome measures
- Assess 2-year orbital LC after 12 Gy in 6 fractions. [Time frame: 24 Months after Treatment]
Secondary outcome measures (5)
- Response rates (complete/partial/minimal response, stable/progressive disease) [Time frame: 6 months and 12 months after treatment]
- Evaluate orbital local control [Time frame: 5 years after treatment]
- Assess freedom from further in-field RT (FFRT), freedom from distant relapse (FFDR) and overall survival (OS) [Time frame: 2 year and 5 year after treatment]
- Health-Related Quality of Life using the EORTC QLQ-C30 [Time frame: 5 years after treatment]
- Ocular Toxicity per CTCAE (5.0) [Time frame: 2 year and 5 year after treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- BC Cancer Vancouver — Vancouver
Identifiers
NCT: NCT07210749 · 12-OLY