Cervix CancerPhase 1/2NCT04514692
Bone Marrow Sparing Image-Guided Radiation Therapy (RT) Incorporating Novel Use of GCSF and FDG-PET Imaging
A Phase 1/2 study testing GCSF in people with Cervix Cancer and Endometrial Cancer, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervix Cancer, Endometrial Cancer
- What is being tested?
- GCSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 27 Sep 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Treatment for other cancer in the past 2 years
- Previous pelvic radiation
- Medical condition that prevents receiving chemotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Cancer Institute Palo Alto
Stanford, California, 94034
About this study
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
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. 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.
Read the detailed description
This is a phase 1/2 study. The phase 1 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 follow-up.
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.
- Conditions
- Cervix Cancer, Endometrial Cancer
- Being tested
- GCSF
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCSFDrug
Also called Filgrastim, Neupogen, Zarxio, G-CSF
Granulocyte Colony Stimulating Factor (GCSF)
| Study group | Role | What they receive |
|---|---|---|
| Phase I -Dose finding, Cohort 1 | Experimental | Dosing will occur in cohorts of 3 patients with the start at dose of GCSF will be 780 mcg x 3 days Receives: Drug: GCSF |
| Phase I -Dose finding, Cohort 2 | Experimental | Dosing will occur in cohorts of 3 patients, If 3 out of 3 patients achieve the target SUVmean, the GCSF dose will be 780 mcg x 2 days Receives: Drug: GCSF |
| Phase I -Dose finding, Cohort 3 | Experimental | Dosing will occur in cohorts of 3 patients, If 3 out of 3 patients achieve the target SUVmean, the GCSF dose will be 780 mcg x 1 day Receives: Drug: GCSF |
| Phase II-G-CSF | Experimental | Phase 2 participants will be treated with the optimal dose of GCSF found in the phase 1 portion of the study. Receives: Drug: GCSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving Recommended Phase 2 Dose (RP2D) Criteria
RP2D will be defined as the dose at which the standard uptake value (SUV) on D5 FDG PET reaches a target SUVmean of 2.5 or higher, with normalization of white blood cells (WBC) and absolute neutrophil count (ANC) prior to the start of radiation. The outcome will be reported as the number of participants who meet these criteria.
Measured: Up to 1 day after completing GCSF
Number of Participants Experiencing Grade 3 or Greater Neutropenia (ANC < 1000/mm³)
Rate of grade 3 or greater neutropenia (ANC < 1000/mm³ at any point of therapy) was monitored using regular complete blood count (CBC) with differential.
Measured: Up to 7 weeks after starting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start1 Feb 2021
- Primary completion27 Sep 2023
- Study completion27 Sep 2023
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervix CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Kidd, Stanford University
- Investigators
- Elizabeth A Kidd, MD, Principal investigator, Stanford Universiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514692
- Sponsor's protocol ID
- IRB-56842
- Other IDs
- GYN0007, NCI-2021-03444
- Status last verified
- Feb 2025
- First submitted
- 12 Aug 2020
- Last updated
- 23 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04514692
- Acronym / sponsor ID
- IRB-56842
- Conditions
- Cervix Cancer, Endometrial Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 17 Aug 2020 (actual)
- Results
- Posted 23 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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.
Detailed description
This is a phase 1/2 study. The phase 1 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 follow-up.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase I -Dose finding, Cohort 1 | Experimental | Drug: GCSFDosing will occur in cohorts of 3 patients with the start at dose of GCSF will be 780 mcg x 3 days |
| Phase I -Dose finding, Cohort 2 | Experimental | Drug: GCSFDosing will occur in cohorts of 3 patients, If 3 out of 3 patients achieve the target SUVmean, the GCSF dose will be 780 mcg x 2 days |
| Phase I -Dose finding, Cohort 3 | Experimental | Drug: GCSFDosing will occur in cohorts of 3 patients, If 3 out of 3 patients achieve the target SUVmean, the GCSF dose will be 780 mcg x 1 day |
| Phase II-G-CSF | Experimental | Drug: GCSFPhase 2 participants will be treated with the optimal dose of GCSF found in the phase 1 portion of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- Treatment for other cancer in the past 2 years
- Previous pelvic radiation
- Medical condition that prevents receiving chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GCSFAlso: Filgrastim, Neupogen, Zarxio, G-CSFGranulocyte Colony Stimulating Factor (GCSF) | Drug | Phase I -Dose finding, Cohort 1, Phase I -Dose finding, Cohort 2, Phase I -Dose finding, Cohort 3, Phase II-G-CSF |
Primary outcome
Number of Participants Achieving Recommended Phase 2 Dose (RP2D) Criteria
Time frame: Up to 1 day after completing GCSF
RP2D will be defined as the dose at which the standard uptake value (SUV) on D5 FDG PET reaches a target SUVmean of 2.5 or higher, with normalization of white blood cells (WBC) and absolute neutrophil count (ANC) prior to the start of radiation. The outcome will be reported as the number of participants who meet these criteria.
Number of Participants Experiencing Grade 3 or Greater Neutropenia (ANC < 1000/mm³)
Time frame: Up to 7 weeks after starting treatment
Rate of grade 3 or greater neutropenia (ANC < 1000/mm³ at any point of therapy) was monitored using regular complete blood count (CBC) with differential.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth A Kidd, MD principal investigator
Stanford Universiy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GCSF in people with Cervix Cancer and Endometrial Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Achieving Recommended Phase 2 Dose (RP2D) Criteria (time frame: Up to 1 day after completing GCSF). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.