TBI Using IMRT (VMAT or Tomotherapy) for the Prevention of Pul Toxicities in Patients Undergoing … (NCT04281199) | Clinical Trial Compass
Active — Not RecruitingPhase 1
TBI Using IMRT (VMAT or Tomotherapy) for the Prevention of Pul Toxicities in Patients Undergoing Donor SCT
United States20 participantsStarted 2020-02-28
Plain-language summary
This trial studies how well radiation therapy techniques, volumetric modulated arc therapy (VMAT) and tomotherapy, work to reduce doses to the lung compared to standard total body irradiation methods to prevent pulmonary toxicities. Standard total body irradiation is limited in its ability to spare normal organs, with only the lung being partially spared by lung blocks and risks the development of pulmonary toxicities. Reducing the doses to the lung using VMAT or tomotherapy may improve survival and decrease long term lung side effects in patients undergoing stem cell transplant.
Who can participate
Age range
12 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Karnofsky performance status (KPS) \>= 70
* Acute leukemia or myelodysplastic patients evaluated within 30 days of start of conditioning regimen who would be candidates for TBI-cyclophosphamide (Cy) or TBI-etoposide (VP16) per City of Hope (COH) standard operating procedure (SOP) for allogeneic hematopoietic stem cell transplant
* Patients must be suitable for TBI conditioning regimens as part of transplant per the referring hematologist
* Patients must have adequate organ function for hematopoietic cell transplantation (HCT) as determined by the hematologist
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation
* All subjects must have the ability to understand the treatment and the willingness to sign a written informed consent
* The effects of total body radiation on the developing fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
* Although not mandated by the protocol, the results of the imaging scans and labs (complete blood…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 1 trial using IMRT-based total body irradiation instead of conventional TBI before a donor stem cell transplant — since it's still in Phase 1, what do we know so far about whether this approach is safer or more effective than the standard TBI technique for my specific condition?
2The trial is listed as 'active not recruiting,' which means they're no longer enrolling new patients — does that change any of my options, and are there similar trials or newer versions of this study that I might still be eligible for?
3The main thing this trial is measuring is whether patients can complete all the radiation fractions using IMRT — what does it mean for me that the focus is on feasibility rather than survival or disease outcomes at this stage?
4Since this involves a donor stem cell transplant combined with an experimental radiation delivery method, how does the added complexity of IMRT-based TBI compare in terms of risk to the standard transplant preparation I might otherwise receive?
5Given that this trial is specifically aimed at reducing pulmonary toxicity from total body irradiation, how significant is lung damage as a risk with conventional TBI for someone with my diagnosis, and is that concern relevant enough to my situation that it would be worth exploring whether I could access this approach outside of a trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Completion of all fractions of intensity-modulated radiation therapy (IMRT) total body irradiation (TBI) (volume modulated arc therapy or tomotherapy)