NCT03740464

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
556

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2018

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

November 10, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2019

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2023

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

1 year

First QC Date

November 9, 2018

Last Update Submit

November 9, 2018

Conditions

Epithelial Ovarian CancerColony Stimulating FactorsFebrile NeutropeniaMyelosuppression AdultAdverse EventCost-effectiveness

Outcome Measures

Primary Outcomes (1)

  • febrile neutropenia

    the incidence of febrile neutropenia happened during each course of chemotherapy

    One year

Secondary Outcomes (6)

  • myelosuppression

    One year

  • doses of granulocyte colony stimulating factor

    One year

  • expenses of granulocyte colony stimulating factor

    One year

  • visits to the hospital

    One years

  • adverse events

    One year

  • +1 more secondary outcomes

Study Arms (2)

Study group

EXPERIMENTAL

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

Drug: long-acting granulocyte colony stimulating factorDrug: 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.

Drug: Short-term granulocyte colony stimulating factor

Interventions

long-acting granulocyte colony stimulating factorDRUG

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

Also known as: polyethylene glycol granulocyte colony stimulating factor
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

Control groupStudy group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing to accepted debulking surgeries and adjuvant chemotherapy
  • Good performance status
  • Aged 18 years or older
  • Signed an approved informed consents
  • No immunosuppressive disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31467066DERIVED

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialFebrile Neutropenia

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersNeutropeniaAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Officials

  • Lei Li, M.D.

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, M.D.

CONTACT

13911988831lileigh@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 9, 2018

First Posted

November 14, 2018

Study Start

November 10, 2018

Primary Completion

November 10, 2019

Study Completion

November 10, 2023

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations

CN(1)