Brief Title
Bone Marrow Sparing Image-Guided Radiation Therapy (RT) Incorporating Novel Use of GCSF and FDG-PET Imaging
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
Brief 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.
Detailed 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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Determine the Recommended phase 2 dose (RP2D)
Condition
Cervix Cancer
Intervention
FDG PET/CT
Study Arms / Comparison Groups
Phase I -Dose finding, Cohort 1
Description: Dosing will occur in cohorts of 4 patients with the start at dose of GCSF will be 780 mcg x 3 days
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
29
Start Date
February 2021
Completion Date
February 2024
Primary Completion Date
August 2023
Eligibility Criteria
Inclusion Criteria:
- 2018 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Elizabeth A Kidd, 650-721-4076, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04514692
Organization ID
IRB-56842
Secondary IDs
GYN0007
Responsible Party
Sponsor
Study Sponsor
Stanford University
Study Sponsor
Elizabeth A Kidd, Principal Investigator, Stanford Universiy
Verification Date
August 2020