NCT04281199

TBI Using IMRT (VMAT or Tomotherapy) for the Prevention of Pul Toxicities in Patients Undergoing Donor SCT

Multi-Institutional Pilot Study of Total Body Irradiation Using Intensity Modulated Radiation Therapy (IMRT) (VMAT or Tomotherapy) for Allogeneic HSCT With New Lung Radiation Dose Guidelines to Prevent Pul Toxicities

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 12 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Acute Leukemia
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
PROCEDURE	Hematopoietic Cell Transplantation	Undergo HCT
RADIATION	Intensity-Modulated Radiation Therapy	Undergo IMRT
RADIATION	Tomotherapy	Undergo IMRT with tomotherapy
RADIATION	Total-Body Irradiation	Undergo TBI
RADIATION	Volume Modulated Arc Therapy	Undergo IMRT with VMAT

Timeline

• Start date: 2020-02-28
• Primary completion: 2026-07-14
• Completion: 2026-07-14
• First posted: 2020-02-24
• Last updated: 2025-09-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study