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

• Status: Recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Lenograstim

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