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Radiation Therapy

Orbital Radiation Therapy for Lymphoma

Phase 2
Waitlist Available
Led By Chelsea C Pinnix
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is studying ultra low dose orbital radiation therapy to treat stage I-IV low grade B-cell lymphoma or mantle cell lymphoma involving the orbit of the eye. This type of radiation therapy uses external beam radiation to destroy cancer cells and may be effective with fewer side effects.

Who is the study for?
This trial is for adults with stage I-IV indolent B-cell or mantle cell lymphoma affecting the eye area. Participants must have measurable disease, agree to use contraception if necessary, and can consent to treatment. Those with aggressive lymphoma types, prior orbital radiation exceeding safe levels, certain autoimmune diseases, or recent chemotherapy are excluded.Check my eligibility
What is being tested?
The study tests ultra low dose external beam radiation therapy targeted at the orbit of the eye in patients with specific types of lymphoma. The goal is to see if this approach effectively treats cancer while minimizing side effects compared to higher doses.See study design
What are the potential side effects?
Potential side effects may include irritation or damage to the skin and tissues around the eyes, dry or teary eyes, cataracts formation over time, and possible vision changes due to radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I will receive treatment throughout my body after eye radiation, and its timing will be noted.
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I agree to use contraception or abstain from sex during the study.
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My eye lymphoma is visible on scans or to doctors after a biopsy confirmed it's B cell type.
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I have a type of slow-growing B cell lymphoma but not CLL/SLL.
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I have issues in both eyes, but only one has been confirmed with disease.
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I am using or willing to use two forms of birth control or am not able to become pregnant.
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I can understand and agree to the study's details on my own.
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I am a woman who can have children and have a negative pregnancy test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Local orbital control (i.e. local control within the radiation field)
Secondary outcome measures
Complete response rate
Freedom from distant relapse rates
Incidence of acute and chronic ocular toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (low dose orbital EBRT)Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
External Beam Radiation Therapy
2006
Completed Phase 3
~3070

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,596 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,399 Total Patients Enrolled
Chelsea C PinnixPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
70 Total Patients Enrolled

Media Library

External Beam Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02494700 — Phase 2
Follicular Lymphoma Research Study Groups: Treatment (low dose orbital EBRT)
Follicular Lymphoma Clinical Trial 2023: External Beam Radiation Therapy Highlights & Side Effects. Trial Name: NCT02494700 — Phase 2
External Beam Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02494700 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What side effects have been commonly reported with Orbital Radiation treatments?

"There is some data supporting the safety of Orbital Radiation, but none yet supporting its efficacy. It received a score of 2."

Answered by AI

Are new patients being accepted into this research project?

"According to the latest information available on clinicaltrials.gov, this study is not currently looking for new patients. This trial was first made public on July 6th, 2015 and received its most recent update June 20th, 2022. With that being said, there are 1,814 other trials which ARE actively recruiting participants."

Answered by AI
~1 spots leftby Jun 2024