Gynecologic CancerPhase 4NCT03793205
G-CSF for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients
A Phase 4 study testing Long-acting G-CSF and Short-acting G-CSF in people with Gynecologic Cancer and Myelosuppression Adult, run by Lei Li at 1 site in China.
Trial summary
This study aims to analyze the effects of long-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in gynecologic cancer patients. Patients all accepted platinum-based chemotherapy 3-4 weeks once per course. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer, Myelosuppression Adult, Febrile Neutropenia
- What is being tested?
- Long-acting G-CSF and Short-acting G-CSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2019to 1 Jan 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Confirmed primary gynecologic cancer
- Good performance status
- Aged 18 years or older
- Signed an approved informed consents
- No immunosuppressive disease
Who cannot join
- Not meeting all of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, MD, 008613911988831, lileigh@163.com
About this study
Official title: Long-acting Granulocyte Colony Stimulating Factor for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients: A Prospective Cohort Study
This study aims to analyze the effects of long-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in gynecologic cancer patients. Patients all accepted platinum-based chemotherapy 3-4 weeks once per course. The primary end is the incidence of FN in every course of chemotherapy. After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF. The secondary ends include: the incidences of myelosuppression, doses of G-CSF and its expenses, visits to outpatient and emergency clinics, adverse events related to G-CSF.
- Conditions
- Gynecologic Cancer, Myelosuppression Adult, Febrile Neutropenia, Chemotherapy-induced Neutropenia
- Being tested
- Long-acting G-CSF, Short-acting G-CSF
- Medical subject headings
- Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-acting G-CSFDrug
Long-acting G-CSF will be given 48 hours after the chemotherapy. A supplement of short-acting G-CSF will be given as required.
Short-acting G-CSFDrug
Short-acting G-CSF will be given as required 24 hours after the chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Long-acting G-CSF group | Experimental | Patients in long-acting G-CSF group accept long-acting with or without short-acting G-CSF. Receives: Drug: Long-acting G-CSF |
| Short-acting G-CSF group | Experimental | Patients in long-acting G-CSF group only accept short-acting G-CSF. Receives: Drug: Short-acting G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of febrile neutropenia
Incidence of febrile neutropenia in each course
Measured: One year
Secondary outcomes (3)
Incidences of grade 3/4 myelosuppression
Incidences of grade 3/4 myelosuppression in each course
Measured: One year
Times of visits to outpatient and emergency clinics
Visits to outpatient and emergency clinics in each course
Measured: One year
Doses of G-CSF
Doses of G-CSF administrated in each course
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start3 Jan 2019
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793205
- Sponsor's protocol ID
- GO-GCSF
- Status last verified
- Jan 2019
- First submitted
- 3 Jan 2019
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen X, Wu M, Ma S, Tan X, Zhong S, Li L. Effects of long-acting versus short-acting granulocyte colony stimulating factor after radiotherapy in gynecologic malignancies: a prospective observational cohort study. BMC Cancer. 2024 Dec 18;24(1):1512. doi: 10.1186/s12885-024-13296-1.
PubMed 39696092
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-acting Granulocyte Colony Stimulating Factor for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03793205
- Acronym / sponsor ID
- GO-GCSF
- Conditions
- Gynecologic Cancer, Myelosuppression Adult, Febrile Neutropenia, Chemotherapy-induced Neutropenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 4 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to analyze the effects of long-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in gynecologic cancer patients. Patients all accepted platinum-based chemotherapy 3-4 weeks once per course. The primary end is the incidence of FN in every course of chemotherapy. After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF. The secondary ends include: the incidences of myelosuppression, doses of G-CSF and its expenses, visits to outpatient and emergency clinics, adverse events related to G-CSF.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF.
| Arm | Type | Receives |
|---|---|---|
| Long-acting G-CSF group | Experimental | Drug: Long-acting G-CSFPatients in long-acting G-CSF group accept long-acting with or without short-acting G-CSF. |
| Short-acting G-CSF group | Experimental | Drug: Short-acting G-CSFPatients in long-acting G-CSF group only accept short-acting G-CSF. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed primary gynecologic cancer
- Good performance status
- Aged 18 years or older
- Signed an approved informed consents
- No immunosuppressive disease
Key exclusion criteria (1 listed)
- Not meeting all of the inclusion criteria
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 |
|---|---|---|
| Long-acting G-CSFLong-acting G-CSF will be given 48 hours after the chemotherapy. A supplement of short-acting G-CSF will be given as required. | Drug | Long-acting G-CSF group |
| Short-acting G-CSFShort-acting G-CSF will be given as required 24 hours after the chemotherapy. | Drug | Short-acting G-CSF group |
Primary outcome
Incidence of febrile neutropenia
Time frame: One year
Incidence of febrile neutropenia in each course
3 secondary outcomes
Incidences of grade 3/4 myelosuppression
Time frame: One year
Times of visits to outpatient and emergency clinics
Time frame: One year
Doses of G-CSF
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
- Derived from this study: PubMed 39696092Chen X, Wu M, Ma S, Tan X, Zhong S, Li L. Effects of long-acting versus short-acting granulocyte colony stimulating factor after radiotherapy in gynecologic malignancies: a prospective observational cohort study. BMC Cancer. 2024 Dec 18;24(1):1512. doi: 10.1186/s12885-024-13296-1.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Long-acting G-CSF and Short-acting G-CSF in people with Gynecologic Cancer and Myelosuppression Adult, run by Lei Li at 1 site in China.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Jan 2019. 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 China. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Li (+8613911988831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of febrile neutropenia (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03793205, which also lists 1 linked publication.
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 7 Jan 2019.