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Radiation Therapy

Radiation Therapy for Lymphoma

N/A

Waitlist Available

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.

Must have clinically confirmed relapsed/refractory Hodgkin/non-Hodgkin lymphoma

Must not have

If known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected) then patient is not eligible for treatment of liver lesions

Cardiovascular disease-related requirement for daily supplemental oxygen therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years after last dose of radiation

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am not currently breastfeeding.

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My lymphoma has returned or didn't respond to treatment.

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I have a tumor that can be measured and fits the size for radiation treatment.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have active Hepatitis B or C.

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I need daily oxygen therapy due to heart disease.

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I don't have any significant muscle disorders or recent muscle injuries.

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I haven't had significant radiation therapy to the area that's now being considered for treatment.

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I have never needed steroids for non-infectious lung inflammation.

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I do not have interstitial lung disease.

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I have not had unstable chest pain in the last 3 months.

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My lymphoma cannot be treated effectively with low-dose radiation.

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I do not have a current seizure disorder.

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I do not have any serious heart conditions.

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I have a history of serious heart rhythm problems.

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I have a serious heart condition.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years after last dose of radiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose Per Fraction of Radiation

Secondary study objectives

Local Control of Treated Lesions After Radiation Treatment

Overall Response Rate to Radiation Treatment

Overall Survival After Radiation Treatment

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

Group III: Dose-Finding Group 2 - Dose Level 2Experimental Treatment1 Intervention

Group IV: Dose-Finding Group 1 - Dose Level 1Experimental Treatment1 Intervention

Group V: Dose-Finding Group 0 - Dose Level 0Experimental Treatment1 Intervention

0 / 17Eligibility criteria met