Clinical trial NCT03701841: Efficacy, Safety and Cost-effectiveness of PEG-rhG-CSF for Primary vs Secondary Prophylaxis
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chemotherapy-induced Neutropenia
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2018-10-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of FN rate
timeFrame: through study completion, an average of 2 year
measure: Proportion of patients completing chemotherapy on schedule
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Incidence of 3-4 grade of neutropenia
timeFrame: through study completion, an average of 2 year
measure: FN-related hospitalization and antibiotic use
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial cancer center
state: Anhui
Study officials:
References: