Orbital LymphomaNCT07210749
Radiotherapy 12Gy in 6 Fractions For Orbital Lymphoma
A study testing External Beam Radiation Therapy in people with Orbital Lymphoma, run by British Columbia Cancer Agency at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orbital Lymphoma
- What is being tested?
- External Beam Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2026to 31 Aug 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
BC Cancer Vancouver
Vancouver, British Columbia, V5Z4E6
Sandy Chang, 6048776000 ext. 202199, sandy.chang@bccancer.bc.ca
About this study
Official title: A Phase II Trial Assessing 12 Gy in 6 Fractions Radiotherapy for Low-Grade B-cell Orbital Lymphoma
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.
- Conditions
- Orbital Lymphoma
- Being tested
- External Beam Radiation Therapy
- Medical subject headings
- Orbital lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Beam Radiation TherapyRadiation
12 Gy in 6 fractions of external beam radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| 12 Gy in 6 fractions of external beam radiation therapy | Experimental | 12 Gy in 6 fractions of conventional external beam radiation therapy using standard-of-care radiation volumes for low-grade orbital lymphoma Receives: Radiation: External Beam Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess 2-year orbital LC after 12 Gy in 6 fractions.
Measured: 24 Months after Treatment
Secondary outcomes (5)
Response rates (complete/partial/minimal response, stable/progressive disease)
Measured: 6 months and 12 months after treatment
Evaluate orbital local control
Measured: 5 years after treatment
Assess freedom from further in-field RT (FFRT), freedom from distant relapse (FFDR) and overall survival (OS)
Measured: 2 year and 5 year after treatment
Health-Related Quality of Life using the EORTC QLQ-C30
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) measures health-related quality of life through 5 functional, 9 symptom, and 1 global health status scale; minimum score = 0, maximum score = 100 (for functional scales, higher is better; for symptom scales, lower is better)
Measured: 5 years after treatment
Ocular Toxicity per CTCAE (5.0)
Measured: 2 year and 5 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Dec 2026 (estimated)
- Primary completion31 Aug 2035 (estimated)
- Study completion31 Aug 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orbital LymphomaStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 12 Gy in 6 fractions external beam radiotherapy using standard-of-care radiation volumes for low-grade orbital lymphoma.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Chan, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210749
- Sponsor's protocol ID
- 12-OLY
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Assessing 12 Gy in 6 Fractions Radiotherapy for Low-Grade B-cell Orbital Lymphoma
- ClinicalTrials.gov ID
- NCT07210749
- Acronym / sponsor ID
- 12-OLY
- Conditions
- Orbital Lymphoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Aug 2035 (estimated)
- Study completion
- 31 Aug 2036 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 12 Gy in 6 fractions external beam radiotherapy using standard-of-care radiation volumes for low-grade orbital lymphoma.
| Arm | Type | Receives |
|---|---|---|
| 12 Gy in 6 fractions of external beam radiation therapy | Experimental | Radiation: External Beam Radiation Therapy12 Gy in 6 fractions of conventional external beam radiation therapy using standard-of-care radiation volumes for low-grade orbital lymphoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External Beam Radiation Therapy12 Gy in 6 fractions of external beam radiation therapy | Radiation | 12 Gy in 6 fractions of external beam radiation therapy |
Primary outcome
Assess 2-year orbital LC after 12 Gy in 6 fractions.
Time frame: 24 Months after Treatment
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
Related trials for Orbital Lymphoma
Active, not recruitingPhase 2
Ultra Low Dose Orbital Radiation Therapy in Treating Patients With Stage I-IV Indolent B-cell Lymphoma or Mantle Cell Lymphoma
Ann Arbor Stage I B-Cell Non-Hodgkin Lymphoma, Ann Arbor Stage I Grade 1 Follicular Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Beam Radiation Therapy in people with Orbital Lymphoma, run by British Columbia Cancer Agency at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fermin Hoq (604-877-6000 ext. 675076, fermin.hoq1@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess 2-year orbital LC after 12 Gy in 6 fractions. (time frame: 24 Months after Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.