Epithelial Ovarian CancerPhase 3NCT03740464
Long-acting G-CSF for Febrile Neutropenia
A Phase 3 study testing long-acting granulocyte colony stimulating factor and Short-term granulocyte colony stimulating factor in people with Epithelial Ovarian Cancer and Colony Stimulating Factors, 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 epithelial ovarian cancer. Patients are randomized into study group and control group. In study group, patients accept long-acting G-CSF 48 hours from the chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Colony Stimulating Factors, Febrile Neutropenia
- What is being tested?
- long-acting granulocyte colony stimulating factor and Short-term granulocyte colony stimulating factor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 556 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2018to 10 Nov 2023
- Phase
- Phase 3
- 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
- Willing to accepted debulking surgeries and adjuvant chemotherapy
- 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 Febrile Neutropenia in Epithelial Ovarian Cancer: A Phase 3 Randomized Control Study
This study aims to analyze the effects of long-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in epithelial ovarian cancer. Patients are randomized into study group and control group. In study group, patients accept long-acting G-CSF 48 hours from the chemotherapy. While the control group accept regular treatment rather than long-acting G-CSF. The primary end is the incidence of FN in every course of chemotherapy. 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
- Epithelial Ovarian Cancer, Colony Stimulating Factors, Febrile Neutropenia, Myelosuppression Adult, Adverse Event, Cost-effectiveness
- Being tested
- long-acting granulocyte colony stimulating factor, Short-term granulocyte colony stimulating factor
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
long-acting granulocyte colony stimulating factorDrug
Also called polyethylene glycol granulocyte colony stimulating factor
A 6 mg of polyethylene glycol granulocyte colony stimulating factor will be given to patients of study group
Short-term granulocyte colony stimulating factorDrug
Short-term granulocyte colony stimulating factor will be given to all patients according to the severity of myelosuppression
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Patients in study group accept long-acting granulocyte colony stimulating factor 48 hours from the chemotherapy and regular interventions for myelosuppression. Receives: Drug: long-acting granulocyte colony stimulating factor; Drug: Short-term granulocyte colony stimulating factor |
| Control group | Active comparator | Patients in control group only accept regular interventions for myelosuppression rather than long-acting granulocyte colony stimulating factor. Receives: Drug: Short-term granulocyte colony stimulating factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
febrile neutropenia
the incidence of febrile neutropenia happened during each course of chemotherapy
Measured: One year
Secondary outcomes (6)
myelosuppression
the incidence of the incidence of febrile neutropenia happened during each course of chemotherapy happened during each course of chemotherapy
Measured: One year
doses of granulocyte colony stimulating factor
total doses of all granulocyte colony stimulating factor
Measured: One year
expenses of granulocyte colony stimulating factor
total expenses of all granulocyte colony stimulating factor
Measured: One year
visits to the hospital
visits to outpatient and emergency clinics
Measured: One years
adverse events
adverse events related to G-CSF according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Measured: One year
progression-free survival
progression-free survival after the primary treatment of ovarian cancer
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start10 Nov 2018
- Primary completion10 Nov 2019 (estimated)
- Study completion10 Nov 2023 (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 Epithelial Ovarian 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 556 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
- Investigators
- Lei Li, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740464
- Sponsor's protocol ID
- EOC-GCSF
- Status last verified
- Nov 2018
- First submitted
- 9 Nov 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li L, Ma S, Wu M, Tan X, Zhong S, Lang J. The prophylactic effects of long-acting granulocyte colony-stimulating factor for febrile neutropenia in newly diagnosed patients with epithelial ovarian cancer: a randomised controlled study. BMJ Support Palliat Care. 2019 Dec;9(4):373-380. doi: 10.1136/bmjspcare-2019-001862. Epub 2019 Aug 29.
PubMed 31467066
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-acting Granulocyte Colony Stimulating Factor for the Prevention Febrile Neutropenia in Epithelial Ovarian Cancer: A Phase 3 Randomized Control Study
- ClinicalTrials.gov ID
- NCT03740464
- Acronym / sponsor ID
- EOC-GCSF
- Conditions
- Epithelial Ovarian Cancer, Colony Stimulating Factors, Febrile Neutropenia, Myelosuppression Adult, Adverse Event, Cost-effectiveness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 556 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- 10 Nov 2019 (estimated)
- Study completion
- 10 Nov 2023 (estimated)
- First posted
- 14 Nov 2018 (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 epithelial ovarian cancer. Patients are randomized into study group and control group. In study group, patients accept long-acting G-CSF 48 hours from the chemotherapy. While the control group accept regular treatment rather than long-acting G-CSF. The primary end is the incidence of FN in every course of chemotherapy. 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: long-acting granulocyte colony stimulating factor, Drug: Short-term granulocyte colony stimulating factorPatients in study group accept long-acting granulocyte colony stimulating factor 48 hours from the chemotherapy and regular interventions for myelosuppression. |
| Control group | Active comparator | Drug: Short-term granulocyte colony stimulating factorPatients in control group only accept regular interventions for myelosuppression rather than long-acting granulocyte colony stimulating factor. |
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)
- Willing to accepted debulking surgeries and adjuvant chemotherapy
- 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 granulocyte colony stimulating factorAlso: polyethylene glycol granulocyte colony stimulating factorA 6 mg of polyethylene glycol granulocyte colony stimulating factor will be given to patients of study group | Drug | Study group |
| Short-term granulocyte colony stimulating factorShort-term granulocyte colony stimulating factor will be given to all patients according to the severity of myelosuppression | Drug | Control group, Study group |
Primary outcome
febrile neutropenia
Time frame: One year
the incidence of febrile neutropenia happened during each course of chemotherapy
6 secondary outcomes
myelosuppression
Time frame: One year
doses of granulocyte colony stimulating factor
Time frame: One year
expenses of granulocyte colony stimulating factor
Time frame: One year
visits to the hospital
Time frame: One years
adverse events
Time frame: One year
progression-free survival
Time frame: Five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Derived from this study: PubMed 31467066Li L, Ma S, Wu M, Tan X, Zhong S, Lang J. The prophylactic effects of long-acting granulocyte colony-stimulating factor for febrile neutropenia in newly diagnosed patients with epithelial ovarian cancer: a randomised controlled study. BMJ Support Palliat Care. 2019 Dec;9(4):373-380. doi: 10.1136/bmjspcare-2019-001862. Epub 2019 Aug 29.
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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.
Lei Li, M.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing long-acting granulocyte colony stimulating factor and Short-term granulocyte colony stimulating factor in people with Epithelial Ovarian Cancer and Colony Stimulating Factors, 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 14 Nov 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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, M.D. (13911988831 ext. 86, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 NCT03740464, 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 14 Nov 2018.