Radiotherapy 12Gy in 6 Fractions For Orbital Lymphoma

NCT ID: NCT07210749

Last Updated: 2025-10-07

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2036-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Orbital Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

12 Gy in 6 fractions external beam radiotherapy using standard-of-care radiation volumes for low-grade orbital lymphoma.
Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

External Beam Radiation Therapy

Intervention Type RADIATION

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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British Columbia Cancer Agency

OTHER

Sponsor Role lead

Responsible Party

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Matthew Chan

Principal Investigator (Co-PI)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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BC Cancer Vancouver

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Central Contacts

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Sandy Chang

Role: CONTACT

604-675-4100 ext. 202199

Facility Contacts

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Sandy Chang

Role: primary

6048776000 ext. 202199

Other Identifiers

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12-OLY

Identifier Type: -

Identifier Source: org_study_id

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