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.
PRIMARY OBJECTIVES: I. To test whether the investigators can achieve a mean lung dose of \< 8 Gy and still treat the total body at a minimum of 85% prescribed dose in patients undergoing allogeneic hematopoietic stem cell transplantation who are eligible for standard total body irradiation (TBI)-based myeloablative regimens. II. To evaluate TBI coverage from tomotherapy and VMAT with new lung sparing guidelines. III. To assess the rate of adverse events with intensity-modulated radiation therapy (IMRT) TBI: type, frequency, severity, attribution, time course, duration, and complications (acute graft versus host disease \[GvHD\], infections, and delayed neutrophil/platelet engraftment) measured by Bearman and Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. SECONDARY OBJECTIVES: I. To evaluate dose homogeneity for all target and non-target structures using dose volume histograms. II. To evaluate non-relapse mortality at 100 days, and 1 year post IMRT TBI. III. To evaluate relapse-free survival (RFS) at 100 days, and 1 year post IMRT TBI. IV. To evaluate extramedullary recurrence rate at 1 year post IMRT TBI. OUTLINE: Patients undergo TBI using IMRT with VMAT or tomotherapy twice daily (BID) on days -7 to -4 then undergo stem cell transplantation on day 0. After completion of study treatment, patients are followed up at 100 days and 1 year post transplant.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Undergo HCT
Undergo IMRT
Undergo IMRT with tomotherapy
Undergo TBI
Undergo IMRT with VMAT
City of Hope Medical Center
Duarte, California, United States
Completion of all fractions of intensity-modulated radiation therapy (IMRT) total body irradiation (TBI) (volume modulated arc therapy or tomotherapy)
Will be summarized using percentage and its 95% confidence interval.
Time frame: Up to 1 year post transplant
Dose homogeneity for all target and non-target structures
Will use dose volume histograms.
Time frame: Up to 1 year post transplant
Rate of adverse events with IMRT TBI
Type, frequency, severity, attribution, time course, duration, and complications will be measured by Bearman and Common Terminology Criteria for Adverse Events version 5.0. Tables will be constructed to summarize the observed incidence, severity, and type of toxicity, including infection.
Time frame: Up to 1 year post transplant
Rate of complications with IMRT TBI
Will include acute graft versus host disease (aGVHD), infections, delayed neutrophil/platelet engraftment. Cumulative incidence rate will be used for aGVHD, and chronic GVHD.
Time frame: Up to 1 year post transplant
Non-relapse mortality
Cumulative incidence rate will be used.
Time frame: From start of therapy until non-disease related death, or last follow-up, whichever comes first, assessed at 100 days and 1 year
Extramedullary recurrence
Time frame: From start of therapy, assessed at 1 year
Relapse free survival
Kaplan-Meier curves will be used.
Time frame: From start of therapy, assessed at 100 days and 1 year
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