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

Endometrial Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04514692
• Other study ID #: IRB-56842
• Secondary ID: GYN0007
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 1, 2021
• Est. completion date: May 1, 2026

Study information

• Verified date: March 2023
• Source: Stanford University
• Contact: Camellia Djebroun
• Phone: 650-721-4076
• Email: cdjebrou[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervix Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Uterine Cervical Neoplasms

Intervention

Diagnostic Test:
• FDG PET/CT
Fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT)

Drug:
• GCSF
Granulocyte Colony Stimulating Factor (GCSF)

Locations

Country	Name	City	State
United States	Stanford Cancer Institute Palo Alto	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the Recommended phase 2 dose (RP2D)	Recommended phase 2 dose (RP2D) will be defined as the dose at which the standard uptake value (SUV) on D5 FDG PET reaches target SUVmean of 2.5 or higher with normalization of white blood cells (WBC) and ANC prior to start of radiation.	12 months
Primary	Determine the rate of grade 3 or greater neutropenia (ANC < 1000/mm3 at any point of therapy)	Rate of grade 3 or greater neutropenia (ANC < 1000/mm3 at any point of therapy) will be monitored by the regular CBC with differential on the study schema and calendar, as per standard of care for patients receiving chemoradiation and/or chemotherapy.	33 months