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

Trial ID or NCT#

NCT04514692

Status

not recruiting iconNOT RECRUITING

Purpose

This is a ÌÇÐÄ´«Ã½ 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. GCSF is being given to stimulate the bone marrow to identify the active (blood cell producing regions) to better spare during pelvic radiation treatment planning.

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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 Criteria:
  1. * Treatment for other cancer in the past 2 years* Previous pelvic radiation* Medical condition that prevents receiving chemotherapy

Investigator(s)

Elizabeth Kidd
Elizabeth Kidd
Radiation oncologist
Professor of Radiation Oncology (Radiation Therapy)

Contact us to find out if this trial is right for you.

Contact

Neha Aidasani
650-721-4076