Advanced Radiation Techniques for Stem Cell Transplant Recipients
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if advanced radiation techniques like VMAT (Volumetric Modulated Arc Therapy) and tomotherapy can better protect the lungs compared to standard total body irradiation for individuals undergoing stem cell transplants. The researchers seek to find out if these methods can reduce lung damage and improve survival. The trial targets patients with acute leukemia or myelodysplastic disorders who are preparing for a stem cell transplant and can tolerate specific radiation treatments. Participants should have stable health and agree to use contraception during the study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, prior therapy like chemotherapy, immunotherapy, or radiotherapy must be completed at least 2 weeks before starting total body irradiation.
What prior data suggests that these radiation techniques are safe for stem cell transplant recipients?
Research has shown that newer radiation techniques like VMAT and tomotherapy might be safer for patients. In past studies, VMAT lowered the risk of side effects such as lung inflammation, kidney problems, nausea, and skin issues compared to older methods. This suggests that VMAT better protects healthy tissues while effectively treating the disease.
Tomotherapy functions similarly, aiming to reduce harm to healthy organs. Both methods deliver precise radiation doses, which can help prevent long-term lung issues after a stem cell transplant. Overall, these findings suggest that VMAT and tomotherapy are well-tolerated and could be safer options for patients receiving radiation therapy as part of their treatment.12345Why are researchers excited about this trial?
Researchers are excited about these advanced radiation techniques for stem cell transplant recipients because they offer more precise targeting of cancerous cells while sparing healthy tissue. Tomotherapy and VMAT (Volumetric Modulated Arc Therapy) are cutting-edge methods that allow for highly accurate radiation delivery, reducing side effects and potentially improving outcomes. Unlike standard total-body irradiation, which can affect large areas, these techniques use sophisticated imaging and modulation to adapt the treatment to each patient's anatomy, leading to a more personalized and effective approach.
What evidence suggests that these radiation techniques are effective for reducing lung doses in stem cell transplant recipients?
This trial will evaluate advanced radiation techniques for stem cell transplant recipients. Studies have shown that new radiation methods like Volumetric Modulated Arc Therapy (VMAT) and tomotherapy might reduce lung damage compared to standard total body irradiation. Research indicates that these advanced techniques can target cancer cells more precisely, sparing normal organs, especially the lungs, from excessive radiation. Specifically, one study found that using VMAT for total body irradiation led to significantly fewer side effects, such as lung inflammation and skin issues. Another study highlighted the potential for lower rates of lung-related problems, which could improve survival rates and quality of life for patients. These findings suggest that VMAT and tomotherapy might effectively reduce lung damage during stem cell transplants. Participants in this trial will undergo total body irradiation using these advanced techniques.678910
Who Is on the Research Team?
Savita V Dandapani
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
This trial is for patients with acute leukemia or myelodysplastic syndrome who are suitable for stem cell transplant and total body irradiation (TBI). They must have a performance status indicating they can care for themselves, agree to use contraception, and not be pregnant. Prior treatments are allowed if completed two weeks before TBI.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants undergo total body irradiation using IMRT with VMAT or tomotherapy twice daily on days -7 to -4
Stem Cell Transplantation
Participants undergo stem cell transplantation on day 0
Follow-up
Participants are monitored for safety and effectiveness, including adverse events and survival rates, at 100 days and 1 year post transplant
What Are the Treatments Tested in This Trial?
Interventions
- Tomotherapy
- Total-Body Irradiation
- VMAT
Trial Overview
The study tests whether advanced radiation techniques like VMAT or tomotherapy can better protect the lungs from damage during TBI compared to standard methods in patients undergoing donor stem cell transplants. The goal is to improve survival rates and reduce long-term lung complications.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients undergo TBI using IMRT with VMAT or tomotherapy BID on days -7 to -4 then undergo stem cell transplantation on day 0.
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Volumetric Modulated Arc Therapy (VMAT) for Total Body ...
To evaluate the dosimetric outcomes, clinical feasibility, and toxicity of VMAT for total body irradiation as an alternative to conventional techniques.
Volumetric modulated arc therapy for total body irradiation
The aim of this study was to investigate the feasibility of achieving clinically acceptable TBI plans with the Pinnacle3 treatment planning system (TPS) and ...
NCT04281199 | TBI Using IMRT (VMAT or Tomotherapy) ...
This trial studies how well radiation therapy techniques, volumetric modulated arc therapy (VMAT) and tomotherapy, work to reduce doses to the lung.
Volumetric modulated arc therapy total body irradiation ...
Normal tissue sparing with VMAT-TBI compared to the 2D-TBI translated to significantly lower rates of pneumonitis, renal toxicity, nausea, skin toxicity, and ...
Six-year Clinical Experience and Treatment Outcomes
Treatment planning, delivery, and treatment outcome data including overall survival (OS), relapse-free survival (RFS), and toxicities were ...
Volumetric modulated arc therapy total body irradiation ...
Normal tissue sparing with VMAT-TBI compared to the 2D-TBI translated to significantly lower rates of pneumonitis, renal toxicity, nausea, skin toxicity, and ...
Volumetric Modulated Arc Therapy Enabled Total Body ...
Treatment planning, delivery, and treatment outcome data including overall survival (OS), relapse-free survival (RFS), and toxicities were analyzed. The ...
Study Details | NCT04281199 | TBI Using IMRT (VMAT or ...
This trial studies how well radiation therapy techniques, volumetric modulated arc therapy (VMAT) and tomotherapy, work to reduce doses to the lung compared ...
Six-year Clinical Experience and Treatment Outcomes
VMAT-TBI provides a safe alternative to cTBI. The dose modulation capability of VMAT-TBI may lead to new treatment strategies, such as simultaneous boost and ...
Technical recommendations for implementation of ...
Early adopters joined to form consensus regarding technical recommendations for Volumetric Modulated Arc Therapy and Helical Tomotherapy TBI.
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