Long-acting G-CSF for Febrile Neutropenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

556 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-10

Study Completion Date

2023-11-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Granulocyte Colony Stimulating Factor for for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer

NCT04101760

Chemotherapy-induced Neutropenia Febrile Neutropenia, Drug-Induced Epithelial Ovarian Cancer +6 more

UNKNOWN PHASE3

G-CSF for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients

NCT03793205

Gynecologic Cancer Myelosuppression Adult Febrile Neutropenia +1 more

UNKNOWN PHASE4

Real World Study of PEG-rhG-CSF in Prevention of Chemotherapy-induced Neutropenia

NCT03846414

Chemotherapy-induced Neutropenia Myelosuppression

UNKNOWN

Study Evaluating PEG-G-CSF Injectionin Preventing Neutropenia After Chemotherapy

NCT06711523

Neutropenia, Chemotherapy-Induced Febrile Breast Neoplasm Female

ACTIVE_NOT_RECRUITING PHASE3

G-CSF in Preventing Neutropenia in Patients With Solid Tumors Who Are Receiving Chemotherapy

NCT00770172

Chemotherapeutic Agent Toxicity Neutropenia Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epithelial Ovarian Cancer Colony Stimulating Factors Febrile Neutropenia Myelosuppression Adult Adverse Event Cost-effectiveness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study group

Patients in study group accept long-acting granulocyte colony stimulating factor 48 hours from the chemotherapy and regular interventions for myelosuppression.

Group Type EXPERIMENTAL

long-acting granulocyte colony stimulating factor

Intervention Type DRUG

A 6 mg of polyethylene glycol granulocyte colony stimulating factor will be given to patients of study group

Short-term granulocyte colony stimulating factor

Intervention Type DRUG

Short-term granulocyte colony stimulating factor will be given to all patients according to the severity of myelosuppression

Control group

Patients in control group only accept regular interventions for myelosuppression rather than long-acting granulocyte colony stimulating factor.

Group Type ACTIVE_COMPARATOR

Short-term granulocyte colony stimulating factor

Intervention Type DRUG

Short-term granulocyte colony stimulating factor will be given to all patients according to the severity of myelosuppression

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

long-acting granulocyte colony stimulating factor

A 6 mg of polyethylene glycol granulocyte colony stimulating factor will be given to patients of study group

Intervention Type DRUG

Short-term granulocyte colony stimulating factor

Short-term granulocyte colony stimulating factor will be given to all patients according to the severity of myelosuppression

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

polyethylene glycol granulocyte colony stimulating factor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No