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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms

  • Ann Arbor Stage I B-Cell Non-Hodgkin Lymphoma
  • Ann Arbor Stage I Grade 1 Follicular Lymphoma
  • Ann Arbor Stage I Grade 2 Follicular Lymphoma
  • Ann Arbor Stage I Indolent Adult Non-Hodgkin Lymphoma
  • Ann Arbor Stage I Mantle Cell Lymphoma
  • Ann Arbor Stage II B-Cell Non-Hodgkin Lymphoma
  • Ann Arbor Stage II Grade 1 Follicular Lymphoma
  • Ann Arbor Stage II Grade 2 Follicular Lymphoma
  • Ann Arbor Stage II Indolent Adult Non-Hodgkin Lymphoma
  • Ann Arbor Stage II Mantle Cell Lymphoma
  • Ann Arbor Stage III B-Cell Non-Hodgkin Lymphoma
  • Ann Arbor Stage III Grade 1 Follicular Lymphoma
  • Ann Arbor Stage III Grade 2 Follicular Lymphoma
  • Ann Arbor Stage III Indolent Adult Non-Hodgkin Lymphoma
  • Ann Arbor Stage III Mantle Cell Lymphoma
  • Ann Arbor Stage IV B-Cell Non-Hodgkin Lymphoma
  • Ann Arbor Stage IV Grade 1 Follicular Lymphoma
  • Ann Arbor Stage IV Grade 2 Follicular Lymphoma
  • Ann Arbor Stage IV Indolent Adult Non-Hodgkin Lymphoma
  • Ann Arbor Stage IV Mantle Cell Lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Follicular
  • Lymphoma, Mantle-Cell
  • Lymphoma, Non-Hodgkin
  • Ocular Adnexal Lymphoma
  • Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma
  • Orbit Lymphoma

NCT number NCT02494700
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Active, not recruiting
Phase Phase 2
Start date July 6, 2015
Completion date June 30, 2025

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