Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Orbital Lymphoma | Orbital Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| External Beam Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 12 Gy in 6 fractions of external beam radiation therapy
- description
- 12 Gy in 6 fractions of conventional external beam radiation therapy using standard-of-care radiation volumes for low-grade orbital lymphoma
- interventionNames
- Radiation: External Beam Radiation Therapy
Primary outcomes (1)
- measure
- Assess 2-year orbital LC after 12 Gy in 6 fractions.
- timeFrame
- 24 Months after Treatment
Secondary outcomes (5)
- measure
- Response rates (complete/partial/minimal response, stable/progressive disease)
- timeFrame
- 6 months and 12 months after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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