Ultra Low Dose Orbital Radiation Therapy in Treating Patients With Stage I-IV Indolent B-cell Lymphoma or Mantle Cell Lymphoma
NCT ID: NCT02494700
Last Updated: 2026-01-07
Study Results
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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ACTIVE_NOT_RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2015-07-06
2027-06-30
Brief Summary
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Detailed Description
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I. To evaluate the efficacy of ultra low dose 4 Gray (Gy) orbital radiation, measured as local orbital control (i.e. local control within the radiation field), in patients with limited and advanced stage low grade B lymphocyte (B cell) lymphoma and mantle cell lymphoma involving the ocular adnexa.
II. To evaluate the efficacy of ultra low dose 4 Gy orbital radiation, measured as complete response, in patients with limited and advanced stage low grade B cell lymphoma and mantle cell lymphoma involving the ocular adnexa.
III. To evaluate the acute and chronic toxicity of radiation to the orbit.
SECONDARY OBJECTIVE:
I. To determine if dynamic contrast enhanced magnetic resonance imaging can predict response to ultra low dose radiation therapy.
OUTLINE:
Patients undergo low dose orbital external beam radiation therapy (EBRT) on 2 consecutive days. Patients experiencing stable or progressive disease after 12-16 weeks of EBRT undergo additional low dose orbital EBRT over 10 fractions. Patients experiencing partial response or minimal response 1 year after EBRT also undergo low dose orbital EBRT over 10 fractions.
After completion of study treatment, patients are followed up every 3-4 months for 6-8 months, every 6-12 months for up to 2 years, and then periodically thereafter.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (low dose orbital EBRT)
Patients undergo two fractions of low dose orbital EBRT on 2 consecutive days. Patients experiencing stable or progressive disease after 12-16 weeks of EBRT undergo additional low dose orbital EBRT over 10 fractions. Patients experiencing partial response or minimal response 1 year after EBRT also undergo low dose orbital EBRT over 10 fractions.
Orbital Radiation
Participants receive radiation to entire involved orbit for a total dose of 4 Gy in 2 fractions over two consecutive days with external beam radiotherapy. If there is stable disease or progressive disease, an additional 20 Gy administered to involved site. If there are two consecutive evaluations with no change in disease burden then an additional 20 Gy administered. At one year if there is persistent disease, an additional 20 Gy administered to involved site.
External Beam Radiation Therapy
Undergo orbital EBRT
Interventions
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Orbital Radiation
Participants receive radiation to entire involved orbit for a total dose of 4 Gy in 2 fractions over two consecutive days with external beam radiotherapy. If there is stable disease or progressive disease, an additional 20 Gy administered to involved site. If there are two consecutive evaluations with no change in disease burden then an additional 20 Gy administered. At one year if there is persistent disease, an additional 20 Gy administered to involved site.
External Beam Radiation Therapy
Undergo orbital EBRT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have measurable disease within the orbit, either clinically and/or radiographically after biopsy confirmation of B cell lymphoma.
* Bilateral ocular adnexal involvement is permitted, if biopsy confirms unilateral disease and there is high clinical suspicion for bilateral disease, biopsy of the contralateral ocular adnexa can be waived.
* Female patients of childbearing potential must have a negative serum pregnancy test (βhCG) within 2 weeks of protocol entry.
* Planned systemic therapy after orbital radiation therapy is permitted however the timing of systemic therapy will be recorded and patients will be stratified according to receipt of adjuvant systemic therapy.
* Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study.
* Female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post-menopausal (free from menses \> two years or surgically sterilized).
* Patients must have the ability to give informed consent.
Exclusion Criteria
* Patients with aggressive B cell lymphoma histology, including diffuse large B cell lymphoma (DLBCL) and grade 3 follicular lymphoma.
* Patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
* Patients with a history of prior radiation to the orbit if re-treatment would exceed known orbital tolerance.
* Patients with pre-existing retinopathy.
* Patients who are pregnant.
* Patients with active lupus or scleroderma are ineligible
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Chelsea C Pinnix, M D
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Pinnix CC, Dabaja BS, Gunther JR, Fang PQ, Wu SY, Nastoupil LJ, Strati P, Nair R, Ahmed S, Steiner R, Westin J, Neelapu S, Rodriguez MA, Lee HJ, Wang M, Flowers C, Feng L, Esmaeli B. Response-Adapted Ultralow-Dose Radiation Therapy for Orbital Indolent B-Cell Lymphoma: A Phase 2 Nonrandomized Controlled Trial. JAMA Oncol. 2024 Sep 1;10(9):1195-1203. doi: 10.1001/jamaoncol.2024.2112.
Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2015-01203
Identifier Type: REGISTRY
Identifier Source: secondary_id
2014-1046
Identifier Type: OTHER
Identifier Source: secondary_id
2014-1046
Identifier Type: -
Identifier Source: org_study_id
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