Efficacy, Safety and Cost-effectiveness of PEG-rhG-CSF for Primary vs Secondary Prophylaxis

Sponsor
Anhui Provincial Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03701841
Collaborator
(none)
1,000
1
26
38.4

Study Details

Study Description

Brief Summary

This trial is a multicenter, non-interventional, registered real-world clinical study. Based on available evidence and recommendations of guidelines, tumor patients with high risk of FN and eligible for all enrollment criteria were recruited into primary prophylaxis of PEG-rhG-CSF or secondary prophylaxis of PEG-rhG-CSF according to the real-world clinical pathway without randomization. All patients need to receive at least 2 cycles of PEG-rhG-CSF prophylaxis. Researchers will record the incidence of FN, RDI, FN-related hospitalization, antibiotic use, direct medical care and indirect medical care cost under the real clinical conditions, and assess the efficacy, safety and cost-effectiveness of PEG-rhG-CSF primary prophylaxis versus secondary prophylaxis through sub-group analysis and exploratory research.

Condition or Disease Intervention/Treatment Phase

Detailed Description

Patients with cancer planning for chemotherapy assessed with high risk of febrile neutropenia (FN) according to NCCN and ASCO guidelines are recruited, receiving primary or secondary prophylaxis of PEG-rhG-CSF according to real-world clinical pathway in local cancer center for at least 4 cycles of chemotherapy. The primary outcome is the incidence of FN rate and proportion of patients completing chemotherapy on schedule, the second outcomes are the incidence of 3-4 grade of neutropenia, FN-related hospitalization and antibiotic use, incidence of reduction and delay of chemotherapy dose, safety and pharmacoeconomics of PEG-rhG-CSF.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Efficacy, Safety and Cost-effectiveness of PEG-rhG-CSF for Primary Prophylaxis Versus Secondary Prophylaxis of Chemotherapy Induced Neutropenia in Patients Receiving Chemotherapy With High-risk FN: a Real World Study
Anticipated Study Start Date :
Oct 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
PEG-rhG-CSF primary prophylaxis

Patients receiving chemotherapy who have a overall FN risk >=20% receive PEG-rhG-CSF for primary prophylaxis

Drug: PEG-rhG-CSF
All patients need to receive PEG-rhG-CSF 6mg approximately 24h or 48h after chemotherapy administration once per cycle, at least 2 cycles

PEG-rhG-CSF secondary prophylaxis

Patients receiving chemotherapy who had FN or dose-limited neutropenia receive PEG-rhG-CSF for secondary prophylaxis

Drug: PEG-rhG-CSF
All patients need to receive PEG-rhG-CSF 6mg approximately 24h or 48h after chemotherapy administration once per cycle, at least 2 cycles

Outcome Measures

Primary Outcome Measures

  1. Incidence of FN rate [through study completion, an average of 2 year]

    FN was defined as fever >=38.3°C orally (>=38.0°C for a duration over 2h) or axillary temperature >=38.1°C (>=37.8°C for a duration over 2h) and ANC < 0.5 X 10*9/L

  2. Proportion of patients completing chemotherapy on schedule [through study completion, an average of 2 year]

    proportion of patients completing chemotherapy on schedule

Secondary Outcome Measures

  1. Incidence of 3-4 grade of neutropenia [through study completion, an average of 2 year]

    the second outcomes are the incidence of 3-4 grade of neutropenia

  2. FN-related hospitalization and antibiotic use [through study completion, an average of 2 year]

    FN-related hospitalization and antibiotic use

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Before the start of the study, all patients have been fully understood the research and the must sign the informed consent

  2. Aged 13 years or older

  3. accept at least 4 cycles of chemotherapy

  4. ECOG PS 0-2

  5. expected survival time ≥ 3 months

  6. with -high risk of FN according to researchers

Exclusion Criteria:
  1. accepted stem cell or bone marrow transplant

  2. undergoing any other clinical trial

  3. uncontrolled infection, temperature≥38℃

  4. per-week scheme chemotherapy

  5. severe and uncontrolled diabetes

  6. People with allergic diseases or allergies, or who are allergic to this or other genetically engineered Escherichia coli-derived biological products

  7. Suspected or confirmed drug use, drug abuse, alcoholics

  8. Severe mental or neurological disorders affecting informed consent and/or adverse effect presentation or observation

  9. Severe heart, kidney, liver and other important organs chronic diseases

  10. Pregnancy or lactation in women or women with gestation detection positive before the first time using drug

  11. Patients who have fertility but are unwilling to receive contraception or partners are not willing to accept contraceptives

  12. The investigator believes that the patient's condition is not suitable for this clinical study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anhui Provincial cancer center Hefei Anhui China 230001

Sponsors and Collaborators

  • Anhui Provincial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yue-Yin Pan, Chief Physician, Anhui Provincial Hospital
ClinicalTrials.gov Identifier:
NCT03701841
Other Study ID Numbers:
  • AHP-PSPRWS
First Posted:
Oct 10, 2018
Last Update Posted:
Oct 10, 2018
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 10, 2018