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Radiation
Low-Dose Radiation for Marginal Zone Lymphoma
Phase 2
Recruiting
Led By Jillian Gunther, MD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
Study Summary
This trial tests if lower doses of radiation therapy can help treat MZL, and if needed, escalate the dose.
Who is the study for?
This trial is for adults with stage I-II marginal zone lymphoma who can sign consent. It's open to those who've had prior treatments but still show signs of the disease, and not planning systemic therapy before follow-up. Participants must use birth control if they can have children, and cannot join if they're pregnant or have certain psychiatric conditions that affect compliance.Check my eligibility
What is being tested?
The study tests ultra-low dose radiation therapy as a primary treatment for marginal zone lymphoma. Patients start with low doses which may be increased based on their response to the initial treatment, aiming to control the disease with minimal exposure.See study design
What are the potential side effects?
While specific side effects are not listed here, radiation therapy generally can cause fatigue, skin irritation at the treated site, mild swelling or pain in nearby tissues, and sometimes nausea depending on the area being treated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ultra Low Dose 4 Gy RadiationExperimental Treatment1 Intervention
Participants will receive the ultra-low doses of radiation therapy over 1-2 days
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,426 Total Patients Enrolled
253 Trials studying Lymphoma
32,492 Patients Enrolled for Lymphoma
Jillian Gunther, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have had a condition where my lymphocytes grow abnormally.I am not scheduled for any drug treatments before my first check-up after radiation.I am currently being treated for active scleroderma.I have had previous treatments for my condition, regardless of type or amount.I agree to use effective birth control during the study.I have another cancer that won't affect this treatment.I have used antibiotics or creams for lymphoma treatment.I have received radiation at a site beyond safe levels.My tumor is larger than 7.5 cm.My condition is early-stage marginal zone lymphoma.My lymphoma diagnosis is not marginal zone lymphoma.I have not had any cancer in the last 5 years.I am a woman who can have children and my pregnancy test is negative.I have signs of cancer after treatment, confirmed by a biopsy or scans.
Research Study Groups:
This trial has the following groups:- Group 1: Ultra Low Dose 4 Gy Radiation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Ultra Low Dose 4 Gy Radiation?
"Our team's assessment of Ultra Low Dose 4 Gy Radiation is a score of 2 out of 3, as there is evidence supporting its safety but no confirmation that it may be effective."
Answered by AI
How many individuals are receiving treatment through this research endeavor?
"Affirmative. According to the information provided on clinicaltrials.gov, this research project is actively recruiting participants. The trial was first published on July 28th 2023 and has been updated as of that same date. 50 patients are needed from a single study site."
Answered by AI
Are applications for this trial still being accepted?
"Affirmative. Clinicaltrials.gov's information attests to the fact that this clinical trial, which was set up on July 28th 2023 and revised recently thereafter, is actively recruiting for 50 participants from a single medical centre."
Answered by AI
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