This phase II trial studies how well ultra low dose orbital radiation therapy works in treating patients with stage I-IV low grade (indolent) B-cell lymphoma or mantle cell lymphoma involving the orbit of the eye (space enclosed by the borders of the eye socket). Orbital radiation therapy uses external beam radiation to destroy cancer cells. Using ultra low dose orbital radiation therapy may be effective in treating indolent B-cell lymphoma or mantle cell lymphoma involving the eye and may have fewer side effects.
PRIMARY OBJECTIVES: 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Undergo orbital EBRT
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.
M D Anderson Cancer Center
Houston, Texas, United States
Local orbital control (i.e. local control within the radiation field)
Local orbital event will be estimated using the Kaplan-Meier method.
Time frame: Up to 2 years post-radiation
Complete response rate
Response rate will be estimated along with 95% confidence intervals.
Time frame: Up to 2 years
Local regional control (i.e. local control within the ipsilateral orbit but outside of the radiation field)
Time frame: Up to 2 years post-radiation therapy
Overall survival (OS)
OS will be estimated using the Kaplan-Meier method.
Time frame: Up to 2 years
Freedom from distant relapse rates
Time frame: Up to 2 years
Incidence of acute and chronic ocular toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Toxicity data will be summarized by frequency tables.
Time frame: Up to 2 years
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