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Long-acting G-CSF for Febrile Neutropenia

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ClinicalTrials.gov Identifier: NCT03740464
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Lei Li, Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Cancer Colony Stimulating Factors Febrile Neutropenia Myelosuppression Adult Adverse Event Cost-effectiveness Drug: long-acting granulocyte colony stimulating factor Drug: Short-term granulocyte colony stimulating factor Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 556 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-acting Granulocyte Colony Stimulating Factor for the Prevention Febrile Neutropenia in Epithelial Ovarian Cancer: A Phase 3 Randomized Control Study
Actual Study Start Date : November 10, 2018
Estimated Primary Completion Date : November 10, 2019
Estimated Study Completion Date : November 10, 2023


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.
Drug: long-acting granulocyte colony stimulating factor
A 6 mg of polyethylene glycol granulocyte colony stimulating factor will be given to patients of study group
Other Name: polyethylene glycol granulocyte colony stimulating factor

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

Active Comparator: Control group
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
Short-term granulocyte colony stimulating factor will be given to all patients according to the severity of myelosuppression




Primary Outcome Measures :
  1. febrile neutropenia [ Time Frame: One year ]
    the incidence of febrile neutropenia happened during each course of chemotherapy


Secondary Outcome Measures :
  1. 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

  2. doses of granulocyte colony stimulating factor [ Time Frame: One year ]
    total doses of all granulocyte colony stimulating factor

  3. expenses of granulocyte colony stimulating factor [ Time Frame: One year ]
    total expenses of all granulocyte colony stimulating factor

  4. visits to the hospital [ Time Frame: One years ]
    visits to outpatient and emergency clinics

  5. adverse events [ Time Frame: One year ]
    adverse events related to G-CSF according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03

  6. progression-free survival [ Time Frame: Five years ]
    progression-free survival after the primary treatment of ovarian cancer



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740464


Contacts
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Contact: Lei Li, M.D. 13911988831 ext 86 lileigh@163.com

Locations
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China, Beijing
Lei Li Recruiting
Beijing, Beijing, China, 100730
Contact: Lei Li, MD    008613911988831    lileigh@163.com   
Sponsors and Collaborators
Lei Li
Investigators
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Principal Investigator: Lei Li, M.D. Peking Union Medical College Hospital

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Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03740464     History of Changes
Other Study ID Numbers: EOC-GCSF
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Neutropenia
Febrile Neutropenia
Fever
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms
Sargramostim
Lenograstim
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic