- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03740464
Long-acting G-CSF for Febrile Neutropenia
November 9, 2018 updated by: Lei Li
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
556
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Recruiting
- Lei Li
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Willing to accepted debulking surgeries and adjuvant chemotherapy
- Good performance status
- Aged 18 years or older
- Signed an approved informed consents
- No immunosuppressive disease
Exclusion Criteria:
- Not meeting all of the inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Study group
Patients in study group accept long-acting granulocyte colony stimulating factor 48 hours from the chemotherapy and regular interventions for myelosuppression.
|
A 6 mg of polyethylene glycol granulocyte colony stimulating factor will be given to patients of study group
Other Names:
Short-term granulocyte colony stimulating factor will be given to all patients according to the severity of myelosuppression
|
ACTIVE_COMPARATOR: Control group
Patients in control group only accept regular interventions for myelosuppression rather than long-acting granulocyte colony stimulating factor.
|
Short-term granulocyte colony stimulating factor will be given to all patients according to the severity of myelosuppression
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
febrile neutropenia
Time Frame: One year
|
the incidence of febrile neutropenia happened during each course of chemotherapy
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
myelosuppression
Time Frame: One year
|
the incidence of the incidence of febrile neutropenia happened during each course of chemotherapy happened during each course of chemotherapy
|
One year
|
doses of granulocyte colony stimulating factor
Time Frame: One year
|
total doses of all granulocyte colony stimulating factor
|
One year
|
expenses of granulocyte colony stimulating factor
Time Frame: One year
|
total expenses of all granulocyte colony stimulating factor
|
One year
|
visits to the hospital
Time Frame: One years
|
visits to outpatient and emergency clinics
|
One years
|
adverse events
Time Frame: One year
|
adverse events related to G-CSF according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
One year
|
progression-free survival
Time Frame: Five years
|
progression-free survival after the primary treatment of ovarian cancer
|
Five years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 10, 2018
Primary Completion (ANTICIPATED)
November 10, 2019
Study Completion (ANTICIPATED)
November 10, 2023
Study Registration Dates
First Submitted
November 9, 2018
First Submitted That Met QC Criteria
November 9, 2018
First Posted (ACTUAL)
November 14, 2018
Study Record Updates
Last Update Posted (ACTUAL)
November 14, 2018
Last Update Submitted That Met QC Criteria
November 9, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Wounds and Injuries
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Hematologic Diseases
- Endocrine Gland Neoplasms
- Agranulocytosis
- Leukopenia
- Leukocyte Disorders
- Body Temperature Changes
- Heat Stress Disorders
- Ovarian Neoplasms
- Neutropenia
- Carcinoma, Ovarian Epithelial
- Hyperthermia
- Fever
- Febrile Neutropenia
- Physiological Effects of Drugs
- Immunologic Factors
- Adjuvants, Immunologic
- Lenograstim
Other Study ID Numbers
- EOC-GCSF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Febrile Neutropenia
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Institut RafaelActive, not recruitingPatient Satisfaction | Patient Preference | Febrile Neutropenia, Drug-InducedFrance
-
Hospira, now a wholly owned subsidiary of PfizerCompletedSolid Tumors | Malignant Hemopathy | Chemotherapy-induced Febrile Neutropenia (FN)France
-
University Hospital, BrestCompletedNeutropenia, FebrileFrance
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TTY BiopharmCompletedNeutropenia, FebrileTaiwan
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Kjeld SchmiegelowRecruitingPediatric Cancer | Neutropenia, FebrileDenmark
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AmgenCompletedChemotherapy-induced Febrile NeutropeniaFrance, Italy, Poland, Canada, Spain, Austria, Germany, Greece, Romania, Australia, Ireland
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University Hospital, LilleMinistry of Health, FranceRecruiting
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Hospital Infantil de Mexico Federico GomezHospital Juarez de Mexico; Instituto Nacional de PediatriaCompletedChemotherapy-Induced Febrile Neutropenia
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All India Institute of Medical Sciences, New DelhiTerminatedPediatric Cancer | Neutropenia, FebrileIndia
-
PfizerCompletedNon-Interventional StudyGermany
Clinical Trials on long-acting granulocyte colony stimulating factor
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-
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University of LiegeCompleted
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Ottawa Hospital Research InstituteRecruiting
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Rennes University HospitalCompleted
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Catholic University of the Sacred HeartWithdrawn
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Xiamen Amoytop Biotech Co., Ltd.Shanghai Jiao Tong University Affiliated First People's HospitalCompleted
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University Hospital MuensterCompletedAmyotrophic Lateral Sclerosis | Chronic StrokeGermany