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Image-Guided Radiation Therapy for Cervical Cancer

Phase 1 & 2
Recruiting
Led By Elizabeth A Kidd
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate bone marrow function (white blood cells > 3.0 X 109/L, platelets >100 x 109/L)
Adequate kidney function (serum Cr <1.5 or creatinine clearance >50 mg/dl)
Must not have
Medical condition that prevents receiving chemotherapy
Previous pelvic radiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 33 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if G-CSF can help guide radiation therapy by making cancer cells more visible on imaging.

Who is the study for?
This trial is for individuals with certain stages of cervical or endometrial cancer who haven't had pelvic radiation, other cancer treatments in the past 2 years, or conditions preventing chemotherapy. They must have good kidney and bone marrow function, an ECOG performance status of 0-2, and be able to consent.
What is being tested?
The study tests using GCSF (a growth factor that stimulates white blood cell production) along with FDG-PET/CT imaging to guide radiation therapy planning for better bone marrow sparing in treating cervical and endometrial cancers.
What are the potential side effects?
Potential side effects may include reactions at the injection site from GCSF, increased white blood cell count leading to possible immune system complications, and typical risks associated with PET/CT imaging such as exposure to a small amount of radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood tests show normal white cell and platelet counts.
Select...
My kidney function is within the normal range.
Select...
I can take care of myself and am up and about more than half of the day.
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I haven't had extensive radiation therapy in the abdominal area.
Select...
I have early to advanced cervical or endometrial cancer, with or without prior surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot undergo chemotherapy due to a medical condition.
Select...
I have had radiation therapy to my pelvic area before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~33 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 33 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine the Recommended phase 2 dose (RP2D)
Determine the rate of grade 3 or greater neutropenia (ANC < 1000/mm3 at any point of therapy)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase II-G-CSFExperimental Treatment2 Interventions
Phase 2 participants will be treated with the optimal dose of GCSF found in the phase 1 portion of the study.
Group II: Phase I -Dose finding, Cohort 3Experimental Treatment2 Interventions
Dosing will occur in cohorts of 4 patients, If 4 out of 4 patients achieve the target SUVmean, the GCSF dose will be 780 mcg x 1 day
Group III: Phase I -Dose finding, Cohort 2Experimental Treatment2 Interventions
Dosing will occur in cohorts of 4 patients, If 4 out of 4 patients achieve the target SUVmean, the GCSF dose will be 780 mcg x 2 days
Group IV: Phase I -Dose finding, Cohort 1Experimental Treatment2 Interventions
Dosing will occur in cohorts of 4 patients with the start at dose of GCSF will be 780 mcg x 3 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FDG PET/CT
2014
N/A
~170
GCSF
2009
Completed Phase 2
~350

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,491 Previous Clinical Trials
17,519,116 Total Patients Enrolled
Elizabeth A KiddPrincipal InvestigatorStanford Universiy

Media Library

GCSF Clinical Trial Eligibility Overview. Trial Name: NCT04514692 — Phase 1 & 2
Cervical Cancer Research Study Groups: Phase II-G-CSF, Phase I -Dose finding, Cohort 3, Phase I -Dose finding, Cohort 2, Phase I -Dose finding, Cohort 1
Cervical Cancer Clinical Trial 2023: GCSF Highlights & Side Effects. Trial Name: NCT04514692 — Phase 1 & 2
GCSF 2023 Treatment Timeline for Medical Study. Trial Name: NCT04514692 — Phase 1 & 2
~2 spots leftby May 2025
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