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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 33 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 β€œYes” for the criteria below
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My blood tests show normal white cell and platelet counts.
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My kidney function is within the normal range.
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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.
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I have early to advanced cervical or endometrial cancer, with or without prior surgery.

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

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

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
2,378 Previous Clinical Trials
17,333,334 Total Patients Enrolled
Elizabeth A KiddPrincipal InvestigatorStanford Universiy

Media Library

GCSF Clinical Trial Eligibility Overview. Trial Name: NCT04514692 β€” 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 β€” Phase 1 & 2
GCSF 2023 Treatment Timeline for Medical Study. Trial Name: NCT04514692 β€” Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any positions available for volunteers in this clinical trial?

"The study, which can be found on clinicaltrials.gov, is still recruiting patients. The start date for this research was February 1st, 2021 and the most recent update was on August 17th, 2022."

Answered by AI

Could you explain the common reasons why doctors prescribe GCSF?

"GCSF is primarily used to treat febrile neutropenia. However, it can also be given to patients experiencing neutropenia, infection, or myeloablative chemotherapy in order to mitigate these conditions."

Answered by AI

Can you tell me if there is a precedent for this type of therapy?

"Currently, 168 clinical trials that focus on GCSF are ongoing with 37 Phase 3 studies. The majority of these investigations into GCSF are being conducted in Saint Louis, Missouri; however, there are 4,670 total locations running clinical trials related to this medication."

Answered by AI
~7 spots leftby May 2025