Chemotherapy-induced NeutropeniaPhase 3NCT04101760
Granulocyte Colony Stimulating Factor for for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer
A Phase 3 study testing Long-acting granulocyte colony stimulating factor and Short-acting granulocyte colony stimulating factor in people with Chemotherapy-induced Neutropenia and Febrile Neutropenia, Drug-Induced, run by Lei Li at 1 site in China.
Trial summary
This study aims to analyze the effects of long-acting versus short-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in epithelial ovarian cancer patients. Patients receive platinum-based chemotherapy of 3 to 4 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Neutropenia, Febrile Neutropenia, Drug-Induced, Epithelial Ovarian Cancer
- What is being tested?
- Long-acting granulocyte colony stimulating factor and Short-acting granulocyte colony stimulating factor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 1 Oct 2020
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With definitive pathological results of epithelial ovarian cancer
- With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2
- Aged 18 or older
- Receiving 3-4 weeks per cycle of platinum-based chemotherapy with or without debulking surgery
- Regularly followed up in the study centers
- Provided consent for participation.
Who cannot join
- Failure to meet all the inclusion criteria
- Non-compliance with the study protocols
- With a history of chemotherapy or pelvic radiotherapy for malignancies
- Presence of immunosuppressive diseases such as organ transplantation or acquired immune deficiency syndrome
- Treated with weekly chemotherapy regimens
- Presence of hematological disorders
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 Versus Short-acting Granulocyte Colony Stimulating Factor for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer Patients: A Multicenter Phase 3 Randomized Controlled Study
This study aims to analyze the effects of long-acting versus short-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in epithelial ovarian cancer patients.
Patients receive platinum-based chemotherapy of 3 to 4 weeks. 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 or prophylactic treatment of short-acting G-CSF according to National Comprehensive Cancer Network guidelines.
Read more
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, quality of life, and survival outcomes (progression-free survival and overall survival).
- Conditions
- Chemotherapy-induced Neutropenia, Febrile Neutropenia, Drug-Induced, Epithelial Ovarian Cancer, Colony Stimulating Factors Adverse Reaction, Granulocyte Colony Stimulating Factor, Cost-effectiveness Analysis
- Being tested
- Long-acting granulocyte colony stimulating factor, Short-acting granulocyte colony stimulating factor
- Medical subject headings
- Chemotherapy-Induced Febrile Neutropenia, Carcinoma, Ovarian Epithelial
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
Patients will accept long-acting granulocyte colony stimulating factor at 48 hour after the chemotherapy
Short-acting granulocyte colony stimulating factorDrug
Patients will accept short-acting granulocyte colony stimulating factor followed regular or prophylactic patterns
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Patients in study group accept prophylactic treatment of long-acting granulocyte colony stimulating factor Receives: Drug: Long-acting granulocyte colony stimulating factor |
| Control group | Active comparator | Patients in control group accept regular or prophylactic treatment of short-acting granulocyte colony stimulating factor according to current guidelines Receives: Drug: Short-acting granulocyte colony stimulating factor |
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 during each course of chemotherapy
Measured: One year
Secondary outcomes (6)
Incidence of myelosuppression
Incidence of febrile neutropenia during each course of chemotherapy
Measured: One year
Doses of granulocyte colony stimulating factor
Doses of long-acting and short-acting granulocyte colony stimulating factor used during each course of chemotherapy
Measured: One year
Numbers of visits to the hospital
Visits to the outpatient clinics and emergency room
Measured: One year
Adverse events
Incidence of adverse events related to granulocyte colony stimulating factor according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Measured: One years
Progression-free survival
Progression-free survival after the treatment of ovarian cancer during the study periods
Measured: Two years
Overall survival
Overall survival after the treatment of ovarian cancer during the study periods
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start1 Oct 2019
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced NeutropeniaStudies 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
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hospital, China-Japan Friendship Hospital, Navy General Hospital, Beijing, Seventh Medical Center of PLA Army General Hospital
- 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
- NCT04101760
- Sponsor's protocol ID
- EOC-CSF
- Status last verified
- Oct 2019
- First submitted
- 21 Sep 2019
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data will be shared as a supplement along with the published papers.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-acting Versus Short-acting Granulocyte Colony Stimulating Factor for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer Patients: A Multicenter Phase 3 Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04101760
- Acronym / sponsor ID
- EOC-CSF
- Conditions
- Chemotherapy-induced Neutropenia, Febrile Neutropenia, Drug-Induced, Epithelial Ovarian Cancer, Colony Stimulating Factors Adverse Reaction, Granulocyte Colony Stimulating Factor, Cost-effectiveness Analysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Collaborators
- Beijing Hospital, China-Japan Friendship Hospital, Navy General Hospital, Beijing, Seventh Medical Center of PLA Army General Hospital
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 24 Sep 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 versus short-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in epithelial ovarian cancer patients.
Patients receive platinum-based chemotherapy of 3 to 4 weeks. 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 or prophylactic treatment of short-acting G-CSF according to National Comprehensive Cancer Network guidelines.
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, quality of life, and survival outcomes (progression-free survival and overall survival).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Long-acting granulocyte colony stimulating factorPatients in study group accept prophylactic treatment of long-acting granulocyte colony stimulating factor |
| Control group | Active comparator | Drug: Short-acting granulocyte colony stimulating factorPatients in control group accept regular or prophylactic treatment of short-acting granulocyte colony stimulating factor according to current guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- With definitive pathological results of epithelial ovarian cancer
- With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2
- Aged 18 or older
- Receiving 3-4 weeks per cycle of platinum-based chemotherapy with or without debulking surgery
- Regularly followed up in the study centers
Key exclusion criteria (6 listed)
- Failure to meet all the inclusion criteria
- Non-compliance with the study protocols
- With a history of chemotherapy or pelvic radiotherapy for malignancies
- Presence of immunosuppressive diseases such as organ transplantation or acquired immune deficiency syndrome
- Treated with weekly chemotherapy regimens
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 factorPatients will accept long-acting granulocyte colony stimulating factor at 48 hour after the chemotherapy | Drug | Study group |
| Short-acting granulocyte colony stimulating factorPatients will accept short-acting granulocyte colony stimulating factor followed regular or prophylactic patterns | Drug | Control group |
Primary outcome
Incidence of febrile neutropenia
Time frame: One year
Incidence of febrile neutropenia during each course of chemotherapy
6 secondary outcomes
Incidence of myelosuppression
Time frame: One year
Doses of granulocyte colony stimulating factor
Time frame: One year
Numbers of visits to the hospital
Time frame: One year
Adverse events
Time frame: One years
Progression-free survival
Time frame: Two years
Overall survival
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Individual participant dataSharing planned: Yes. The individual participant data will be shared as a supplement along with the published papers.
Related trials for Chemotherapy-induced Neutropenia
RecruitingObservational study
Mecapegfilgrastim for Prevention of Chemotherapy-Induced Neutropenia in Advanced Breast Cancer
Breast Cancer, Chemotherapy-induced Neutropenia
Not yet recruiting
Impact of a Telemonitoring Device on the Occurever at Home in Children at Risk of Chemotherapy-Induced Neutropenia
Oncopediatrics, Febrile Neutropenia
Active, not recruitingPhase 4
Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
Extensive-stage Small-cell Lung Cancer
Not yet recruitingObservational study
Correlation Between ANC and Bone Pain in Breast Cancer Patients Receiving Long-Acting G-CSF
Breast Cancer, Chemotherapy-Induced Neutropenia
RecruitingPhase 2
Telpegfilgrastim vs Filgrastim for Secondary Prevention of Chemotherapy-Induced Neutropenia in Pediatric Solid Tumors
Solid Tumors, Children
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-acting granulocyte colony stimulating factor in people with Chemotherapy-induced Neutropenia and Febrile Neutropenia, Drug-Induced, 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 6 inclusion and 6 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 8 Oct 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 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. (+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?
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 8 Oct 2019.