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Radiation Therapy
Radiation Therapy for Lymphoma
N/A
Recruiting
Led By Yasmin Hasan, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants who are women must not be breastfeeding.
Men or women ≥ 18 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years after last dose of radiation
Awards & highlights
Study Summary
This trial is testing whether shortened courses of radiation are safe and effective for treating lymphoma.
Who is the study for?
Adults over 18 with relapsed/refractory Hodgkin/non-Hodgkin lymphoma, who've tried standard treatments without success. They must have measurable disease and be in relatively good health (ECOG ≤ 2). Women of childbearing age need a negative pregnancy test and agree to contraception; men must also follow contraceptive guidelines.Check my eligibility
What is being tested?
The trial is testing different doses of radiation therapy to find the safest short-duration treatment for lymphoma. Participants will receive one of five levels of radiation intensity to determine if less exposure is effective and safe compared to the typical 5-6 week regimen.See study design
What are the potential side effects?
Potential side effects include skin reactions at the radiation site, fatigue, nausea, hair loss within treated areas, possible organ damage depending on the area being treated, and an increased risk for secondary cancers long-term.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not currently breastfeeding.
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I am 18 years old or older.
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I have a tumor that can be measured and fits the size for radiation treatment.
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My lymphoma has returned or didn't respond to treatment.
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My lymphoma has returned or didn't respond to treatment.
Select...
I have tried all standard treatments recommended by my doctor.
Select...
I have a tumor that can be measured and fits the size for radiation treatment.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am a man who will use birth control during and up to 7 months after treatment, and I won't donate sperm.
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I am a male who does not produce sperm, so I don't need birth control measures.
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
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My organ functions are within the normal range required for the study.
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I am a woman who can have children and have a negative pregnancy test within the last 3 days.
Select...
I am not currently breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years after last dose of radiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years after last dose of radiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose Per Fraction of Radiation
Secondary outcome measures
Local Control of Treated Lesions After Radiation Treatment
Overall Response Rate to Radiation Treatment
Overall Survival After Radiation Treatment
+3 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Dose-Finding Group 4 - Dose Level 4Experimental Treatment1 Intervention
High-energy radiation will be delivered to a focused area of your body using a treatment machine called a linear accelerator. Radiation will be delivered through an IV. A mold will also be customized to fit your body, so you don't move during the radiation process. The actual time on the radiation treatment machine will be 30-60 minutes. The mold will be removed after the treatment.
The longest possible treatment will be 14 radiation treatments over a course of 3 weeks. The shortest possible treatment will be 3 treatments in duration or less than 1 week. The amount of time required for radiation treatment depends on the dose group your are assigned.
Participants will receive radiation to at least 1 but no more than 5 lesions (areas of body with cancer).
Group II: Dose-Finding Group 3 - Dose Level 3Experimental Treatment1 Intervention
High-energy radiation will be delivered to a focused area of your body using a treatment machine called a linear accelerator. Radiation will be delivered through an IV. A mold will also be customized to fit your body, so you don't move during the radiation process. The actual time on the radiation treatment machine will be 30-60 minutes. The mold will be removed after the treatment.
The longest possible treatment will be 14 radiation treatments over a course of 3 weeks. The shortest possible treatment will be 3 treatments in duration or less than 1 week. The amount of time required for radiation treatment depends on the dose group your are assigned.
Participants will receive radiation to at least 1 but no more than 5 lesions (areas of body with cancer).
Group III: Dose-Finding Group 2 - Dose Level 2Experimental Treatment1 Intervention
High-energy radiation will be delivered to a focused area of your body using a treatment machine called a linear accelerator. Radiation will be delivered through an IV. A mold will also be customized to fit your body, so you don't move during the radiation process. The actual time on the radiation treatment machine will be 30-60 minutes. The mold will be removed after the treatment.
The longest possible treatment will be 14 radiation treatments over a course of 3 weeks. The shortest possible treatment will be 3 treatments in duration or less than 1 week. The amount of time required for radiation treatment depends on the dose group your are assigned.
Participants will receive radiation to at least 1 but no more than 5 lesions (areas of body with cancer).
Group IV: Dose-Finding Group 1 - Dose Level 1Experimental Treatment1 Intervention
High-energy radiation will be delivered to a focused area of your body using a treatment machine called a linear accelerator. Radiation will be delivered through an IV. A mold will also be customized to fit your body, so you don't move during the radiation process. The actual time on the radiation treatment machine will be 30-60 minutes. The mold will be removed after the treatment.
The longest possible treatment will be 14 radiation treatments over a course of 3 weeks. The shortest possible treatment will be 3 treatments in duration or less than 1 week. The amount of time required for radiation treatment depends on the dose group your are assigned.
Participants will receive radiation to at least 1 but no more than 5 lesions (areas of body with cancer).
Group V: Dose-Finding Group 0 - Dose Level 0Experimental Treatment1 Intervention
High-energy radiation will be delivered to a focused area of your body using a treatment machine called a linear accelerator. Radiation will be delivered through an IV. A mold will also be customized to fit your body, so you don't move during the radiation process. The actual time on the radiation treatment machine will be 30-60 minutes. The mold will be removed after the treatment.
The longest possible treatment will be 14 radiation treatments over a course of 3 weeks. The shortest possible treatment will be 3 treatments in duration or less than 1 week. The amount of time required for radiation treatment depends on the dose group your are assigned.
Participants will receive radiation to at least 1 but no more than 5 lesions (areas of body with cancer).
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
997 Previous Clinical Trials
817,668 Total Patients Enrolled
Yasmin Hasan, MDPrincipal InvestigatorUniversity of Chicago - Comprehensive Cancer Center
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently breastfeeding.I am 18 years old or older.I am a male who does not produce sperm, so I don't need birth control measures.I have a tumor that can be measured and fits the size for radiation treatment.I am a man who will use birth control during and up to 7 months after treatment, and I won't donate sperm.I do not have active Hepatitis B or C.I am not sexually active with men and will undergo pregnancy tests as required.I need daily oxygen therapy due to heart disease.My lymphoma has returned or didn't respond to treatment.My lymphoma has returned or didn't respond to treatment.I have tried all standard treatments recommended by my doctor.I am a woman who can have children and have a recent negative pregnancy test.I am a man who will use birth control during and up to 7 months after treatment, and I won't donate sperm.I have a tumor that can be measured and fits the size for radiation treatment.I don't have any significant muscle disorders or recent muscle injuries.I can take care of myself and am up and about more than half of my waking hours.I am not currently using statins, or have been on a stable dose for over 3 months without any issues.I am a male who does not produce sperm, so I don't need birth control measures.I haven't had significant radiation therapy to the area that's now being considered for treatment.I have never needed steroids for non-infectious lung inflammation.I do not have interstitial lung disease.I have not had unstable chest pain in the last 3 months.I am 18 years old or older.My lymphoma cannot be treated effectively with low-dose radiation.I am not currently on cancer treatments except possibly steroids or standard hormone therapies.I have mild or no nerve damage.I have fully recovered from any major surgery before starting treatment.I haven't had chemotherapy within 2 weeks before starting radiation.I haven't taken cancer-targeting drugs within 7 days before starting radiation.I do not have another type of cancer that could affect this study's results.I do not have a current seizure disorder.I do not have any serious heart conditions.I have not had a heart attack or stroke in the last 6 months.I have a history of serious heart rhythm problems.I have a serious heart condition.I have tried all standard treatments recommended by my doctor.I can take care of myself and am up and about more than half of my waking hours.My organs are functioning well according to recent tests.My organ functions are within the normal range required for the study.I am a woman who can have children and have a negative pregnancy test within the last 3 days.I am not currently breastfeeding.
Research Study Groups:
This trial has the following groups:- Group 1: Dose-Finding Group 4 - Dose Level 4
- Group 2: Dose-Finding Group 0 - Dose Level 0
- Group 3: Dose-Finding Group 3 - Dose Level 3
- Group 4: Dose-Finding Group 1 - Dose Level 1
- Group 5: Dose-Finding Group 2 - Dose Level 2
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.
How many participants will this clinical trial accommodate?
"Confirmed. As per the clinicaltrials.gov database, this trial is actively sourcing participants since it was initially posted on September 30th 2021; the latest update being made December 3rd 2021. To date, they are aiming to enrol a total of thirty individuals from just one site."
Answered by AI
Are there any open enrolment opportunities for individuals in this trial?
"Clinicaltrials.gov reveals that this clinical trial, which was first advertised on September 30th 2021, is currently seeking patients for participation. The information has been recently updated as of December 3rd 2021."
Answered by AI
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