Radiotherapy 12Gy in 6 Fractions For Orbital Lymphoma

NCT07210749 | Not Yet Recruiting

• 1 other identifier: 12-OLY
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• Assess 2-year orbital LC after 12 Gy in 6 fractions.

  24 Months after Treatment

Secondary Outcomes (5)

• Response rates (complete/partial/minimal response, stable/progressive disease)

  6 months and 12 months after treatment

• Evaluate orbital local control

  5 years after treatment

• Assess freedom from further in-field RT (FFRT), freedom from distant relapse (FFDR) and overall survival (OS)

  2 year and 5 year after treatment

• Health-Related Quality of Life using the EORTC QLQ-C30

  5 years after treatment

• Ocular Toxicity per CTCAE (5.0)

  2 year and 5 year after treatment

Study Arms (1)

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

Radiation: External Beam Radiation Therapy

Interventions

External Beam Radiation Therapy RADIATION

12 Gy in 6 fractions of external beam radiation therapy

12 Gy in 6 fractions of external beam radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer Vancouver

Vancouver, British Columbia, V5Z4E6, Canada

Location

MeSH Terms

Conditions

Orbital lymphoma

Central Study Contacts

Sandy Chang

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (Co-PI)

Model Details: 12 Gy in 6 fractions external beam radiotherapy using standard-of-care radiation volumes for low-grade orbital lymphoma.

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: October 7, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): August 31, 2035
• Study Completion (Estimated): August 31, 2036
• Last Updated: October 7, 2025

Record last verified: 2025-09

Locations

CA (1)