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Radiation Therapy
Low-Dose Radiation Therapy for Mycosis Fungoides
Phase 2
Recruiting
Led By Bouthaina S Dabaja
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
Patients with pathologically confirmed MF with cutaneous involvement
Patients must have clinically measurable disease of at least 1 lesion on physical (skin) exam
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial looks at using low doses of radiation to treat mycosis fungoides. The hope is that it will be more effective than higher doses with fewer side effects.
Who is the study for?
This trial is for patients with mycosis fungoides, a type of skin lesion. Eligible participants can have any stage of the disease and may be undergoing other treatments. They must not apply certain topical agents to the lesion before joining, and women who can become pregnant need a negative pregnancy test.Check my eligibility
What is being tested?
The study tests ultra low dose radiation therapy's effectiveness in treating mycosis fungoides. It aims to control the disease with fewer side effects than higher doses. Patients' quality of life will also be assessed through questionnaires.See study design
What are the potential side effects?
While specific side effects are not listed, ultra low dose radiation may include skin irritation, fatigue, mild swelling or redness at treatment sites compared to higher doses which often cause more severe reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have mycosis fungoides with skin symptoms.
Select...
I have at least one visible tumor that can be measured.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Local cutaneous control
Secondary outcome measures
Frequency/severity of skin toxicity
Microbiome analysis
Overall survival
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ultra low dose radiation therapy)Experimental Treatment3 Interventions
Patients undergo ultra low dose radiation therapy at the discretion of the treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,925,831 Total Patients Enrolled
104 Trials studying Mycosis Fungoides
4,406 Patients Enrolled for Mycosis Fungoides
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,271 Total Patients Enrolled
10 Trials studying Mycosis Fungoides
399 Patients Enrolled for Mycosis Fungoides
Bouthaina S DabajaPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
345 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active lupus or scleroderma.My skin lesions are not taller than 1 cm from the surface.I have mycosis fungoides with skin symptoms.I have at least one visible tumor that can be measured.My cancer lesions are less than or equal to 1 cm tall and I want them treated.My cancer is at any stage and I am considering radiation therapy.I am not pregnant or have confirmed it with a test if unsure.I am using or will use skin treatments on some lesions, but not on the one to be studied.I stopped using topical treatments on my lesion 24 hours before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ultra low dose radiation therapy)
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 given its blessing to Radiation Therapy?
"While there is some evidence that radiation therapy is safe, it has not been proven effective yet. Therefore, Power gave it a score of 2."
Answered by AI
How many people are part of this experiment?
"That is correct, the clinicaltrials.gov website lists this study as recruiting patients. The trial was established on 1/6/2018, with the most recent update being on 5/13/2022. They are looking to enroll 50 individuals at a single site."
Answered by AI
Are there still open spots in this clinical trial for new participants?
"From the information available on clinicaltrials.gov, it can be inferred that this study is still looking for patients to enroll. The trial was first posted on 1/6/2018, with the most recent update being from 5/13/2022."
Answered by AI
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