Status:
TERMINATED
Bone Marrow Sparing Image-Guided Radiation Therapy (RT) Incorporating Novel Use of GCSF and FDG-PET Imaging
Lead Sponsor:
Stanford University
Conditions:
Cervix Cancer
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
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. Grow...
Detailed Description
This is a phase 1/2 study. The phase 1 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 sa...
Eligibility Criteria
Inclusion
- Gynecologic cancer patients receiving pelvic radiation and chemotherapy, specifically: 1) Stage I-IIIC1 cervix cancer, 2) stage I-III primary vaginal cancer, 3) stage IIIA-IIIC1 endometrial cancer patients status post hysterectomy and lymph node assessment, and 4) recurrent endometrial cancer patients with pelvic confined disease No required para-aortic or extended field radiation
- Age \> 18 years
- 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 10\^9/L, platelets \>100 x 10\^9/L)
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Treatment for other cancer in the past 2 years
- Previous pelvic radiation
- Medical condition that prevents receiving chemotherapy
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04514692
Start Date
February 1 2021
End Date
September 27 2023
Last Update
April 23 2025
Active Locations (1)
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1
Stanford Cancer Institute Palo Alto
Stanford, California, United States, 94034