Single institution study of safety of linac based VMAT TBI for myeloablative treatment in hematologic malignancies.
Total Body Irradiation (TBI) continues to play an important role in myeloablative and non-myeloablative conditioning regimens for Allogeneic Stem Cell Transplant (ASCT). When TBI is used as part of a myeloablative regimen, it is combined with chemotherapy to eradicate malignant cells, as well as to immunosuppress the host to prevent rejection of donor hematopoietic progenitor cells (HPC). This study is a single-institution study to assess the safety of linac based VMAT TBI for myeablative sreatment in hematologic malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Use of linac based Volumetric Arc Therapy (VMAT) to deliver Total Body Irradiation (TBI). The study intervention is a VMAT based delivery technique using a 6 MV photon beam from a Varian TrueBeam® (Palo Alto, CA) equipped with a Millennium multi-leaf collimation (MLC) system3. TBI will be delivered using a Varian TrueBeam linear accelerator with photon beam VMAT capability. VMAT is a radiation technique combining dynamic photon fluence modulation using multi-leaf collimation (MLC) with gantry rotation to deliver a highly conformal dose distribution with improved target coverage and sparing of organs at risk (OARs).
NYU Langone Health
New York, New York, United States
Proportion of patients who achieve excellent coverage while sparing the lung
Excellent coverage while sparing the lung is quantified by meeting the following dosimetric parameters (all parameters must be met): 1. V100%= \>90% (90% of PTV volume getting 100% of the dose). 2. D98\>85% (98% of the volume getting at least 85% of the dose). 3. Mean Lung dose \<900cGy.
Time frame: Up to 1 year post-transplant
Cumulative incidence rate of idiopathic pneumonia syndrome
Non-infectious pneumonia syndrome is defined by the American Thoracic Society as at least 1 of the following without concurrent infection detected on blood culture, broncoalveolar lavage, lung biopsy or sputum: 1. There must also be the absence of cardiac dysfunction, acute renal failure, or iatrogenic fluid overload as etiology for pulmonary dysfunctionMultilobar infiltrates on chest radiograph or computed tomography (CT); 2. Symptoms and signs of pneumonia including dyspnea, cough, cyanosis, hypoxia or pyrexia; 3. New or increased restrictive patters on pulmonary function testing or increased alveolar to arterial oxygen difference
Time frame: Up to 100 days post-transplant
Occurrence of acute GVHD, transplant related mortality, or mortality in the first 100 days following transplant
Time frame: 100 days post-transplant
Event Free Survival (EFS)
Time frame: Up to 1 year post-transplant
Proportion of patients who achieved a mean dose to each kidney (Dmean) < 11Gy
Time frame: Up to 150 days post-transplant
Proportion of patients who have achieved a maximum dose to 2cc of the entire body (D2cc) < 130% of Rx dose.
Time frame: Up to 150 days post-transplant
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Proportion of patients who have achieved a maximum dose to 0.03cc of OARs < 120% of Rx dose.
Time frame: Up to 150 days post-transplant