Bone Marrow Sparing Image-Guided Radiation Therapy (RT) Incorporating Novel Use of GCSF and FDG-PET Imaging

Endometrial Cancer Clinical Trial

Official title: Phase 1 2 Study of Individualized Bone Marrow Sparing Image Guided Radiotherapy Incorporating Novel Use of Granulocyte Colony Stimulating Factor and FDG PET Imaging

Status Recruiting

Clinical Trial Summary

This is a research study using Granulocyte Colony Stimulating Factor (GCSF) as a bone marrow stimulating agent for imaging to guide radiation treatment planning. G-CSF is a type of growth factor. Growth factors are proteins made in the body. G-CSF is a type of growth factor that makes the bone marrow produce white blood cells to reduce the risk of infection after some types of cancer treatment.

Clinical Trial Description

This is a phase 1 and 2 study. The phase I is a dose finding portion of the study and phase 2 will enroll additional patients at the dose found in phase I. Patients in phase I and phase 2 will have the same treatment and followup.

Participants will undergo standard of care diagnostic imaging, complete blood count (CBC) with differential and chemistry labs initially. While receiving the GCSF, participants will have a CBC with differential checked a day after each dose and one day prior to first day of radiation. The treatment planning FDG PET/CT will be performed shortly after the GCSF. During chemoradiation, participants will have weekly CBC with differential checked and other labs as standard of care. ;

Related Conditions & MeSH terms

• Cervix Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Uterine Cervical Neoplasms

• NCT number: NCT04514692
• Study type: Interventional
• Source: Stanford University
• Contact: Camellia Djebroun
• Phone: 650-721-4076
• Email: cdjebrou@stanford.edu
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 1, 2021
• Completion date: May 1, 2026