Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma
- Conditions
- Non-hodgkin LymphomaHodgkin LymphomaLymphoma
- Interventions
- Radiation: Radiation - Dose Level 3Radiation: Radiation - Dose Level 2Radiation: Radiation - Dose Level 0Radiation: Radiation - Dose Level 1Radiation: Radiation - Dose Level 4
- Registration Number
- NCT05019976
- Lead Sponsor
- University of Chicago
- Brief Summary
This study focuses on using shortened courses of radiation for participants with relapsed/refractory Hodgkin/Non-Hodgkin lymphoma. Treatment radiation over 5-6 weeks is often standard of care for many people with lymphoma, but doctors leading this study aim to find out if using radiation for a shorter period of time can be safe for treating lymphoma and if so, what is the safest shortened dose of radiation for participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose-Finding Group 3 - Dose Level 3 Radiation - Dose Level 3 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). Dose-Finding Group 2 - Dose Level 2 Radiation - Dose Level 2 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). Dose-Finding Group 0 - Dose Level 0 Radiation - Dose Level 0 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). Dose-Finding Group 1 - Dose Level 1 Radiation - Dose Level 1 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). Dose-Finding Group 4 - Dose Level 4 Radiation - Dose Level 4 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).
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose Per Fraction of Radiation 1 Month Maximum tolerated dose of radiation per fraction among participants with relapsed/refractory Hodgkin/non-Hodgkin lymphoma as assessed by dose-limiting toxicities (severe side effects that limit the dose of radiation) defined by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
- Secondary Outcome Measures
Name Time Method Overall Response Rate to Radiation Treatment Up to 2 years after last dose of radiation Overall response rate to radiation (including irradiated and non-irradiated lesions) as assessed by computed tomography scans of lesions based on tumor measurements according to Response Evaluation Criteria in Solid Tumors (RECIST criteria Version 1.1 ).
Local Control of Treated Lesions After Radiation Treatment Up to 2 years after last dose of radiation Local control of the treated lesion as assessed by computed tomography (CT) scans of lesions, tumor measurements according to Response Evaluation Criteria in Solid Tumors (RECIST criteria Version 1.1 ) and clinical records.
Rate of Reported Adverse Events Within 1 Month of Radiation 1 Month The rate of reported adverse events (side effects) within 1 month of starting radiation as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Rate of Long-Term Adverse Events (Up to 2 Years) From the End of Radiation Rate of Long-Term Adverse Events (Up to 2 Years) From the End of Radiation Up to 2 years after last dose of radiation The rates of reported long-term adverse events from the end of radiation up to a maximum of 2 years as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Progression-Free Survival of Participants After Radiation Treatment Up to 2 years after last dose of radiation Progression-free survival after radiation as assessed by computed tomography (CT) scans of lesions, tumor measurements according to Response Evaluation Criteria in Solid Tumors and clinical records.
Overall Survival After Radiation Treatment Up to 2 years after last dose of radiation Overall survival after radiation as assessed by computed tomography (CT) scans of lesions, tumor measurements according to Response Evaluation Criteria in Solid Tumors(RECIST Version 1.1) and clinical records.
Trial Locations
- Locations (1)
University of Chicago
🇺🇸Chicago, Illinois, United States