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

NCT04101760 | Unknown Phase 3 DMC

• 1 other identifier: EOC-CSF
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Chemotherapy-induced Neutropenia; Febrile Neutropenia, Drug-Induced; Epithelial Ovarian Cancer; Colony Stimulating Factors Adverse Reaction; Granulocyte Colony Stimulating Factor; Cost-effectiveness Analysis; Quality of Life; Progression-free Survival; Overall Survival

Outcome Measures

Primary Outcomes (1)

• Incidence of febrile neutropenia

  Incidence of febrile neutropenia during each course of chemotherapy

  One year

Secondary Outcomes (6)

• Incidence of myelosuppression

  One year

• Doses of granulocyte colony stimulating factor

  One year

• Numbers of visits to the hospital

  One year

• Adverse events

  One years

• Progression-free survival

  Two years

Study Arms (2)

Study group

EXPERIMENTAL

Patients in study group accept prophylactic treatment of long-acting granulocyte colony stimulating factor

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

Drug: Short-acting granulocyte colony stimulating factor

Interventions

Long-acting granulocyte colony stimulating factor DRUG

Patients will accept long-acting granulocyte colony stimulating factor at 48 hour after the chemotherapy

Study group

Short-acting granulocyte colony stimulating factor DRUG

Patients will accept short-acting granulocyte colony stimulating factor followed regular or prophylactic patterns

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lei Li: lead
• Beijing Hospital: collaborator
• China-Japan Friendship Hospital: collaborator
• Navy General Hospital, Beijing: collaborator
• Seventh Medical Center of PLA Army General Hospital: collaborator

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Chemotherapy-Induced Febrile Neutropenia; Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Febrile Neutropenia; Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Lei Li, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, M.D.

CONTACT

+8613911988831; lileigh@163.com

Ming Wu, M.D.

CONTACT

+8613801224549; wuming@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 21, 2019
• First Posted: September 24, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)