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

  • End date
    Feb 22, 2024
  • participants needed
  • sponsor
    Stanford University
Updated on 4 October 2022
granulocyte colony stimulating factor
growth factor
pet/ct scan
diagnostic procedures
growth factors


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.


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.

Condition Cervix Cancer, Endometrial Cancer
Treatment FDG PET/CT, GCSF
Clinical Study IdentifierNCT04514692
SponsorStanford University
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

international Federation of Gynecology and Obstetrics (FIGO) stage I IIIC1 cervix cancer with no prior treatment or stage IIIA IIIC1 endometrial cancer status post hysterectomy and lymph node assessment
No required para aortic or extended field radiation
Eastern Cooperative Oncology Group (ECOG) performance status 0 2
Adequate kidney function (serum Cr <1.5 or creatinine clearance >50 mg/dl)
Adequate bone marrow function (white blood cells > 3.0 X 109/L, platelets >100 x 109/L)
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

Treatment for other cancer in the past 2 years
Previous pelvic radiation
Medical condition that prevents receiving chemotherapy
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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