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

NCT ID: NCT03701841

Last Updated: 2018-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-31
• Study Completion Date: 2020-12-31

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.

Conditions

Chemotherapy-induced Neutropenia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PEG-rhG-CSF primary prophylaxis

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

PEG-rhG-CSF

Intervention Type: DRUG

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

PEG-rhG-CSF

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yue-Yin Pan

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Anhui Provincial cancer center

Hefei, Anhui, China

Countries

China

Central Contacts

Yueyin Pan, PhD

Role: CONTACT

yueyinpan1965@163.com

86-551-62283411

Other Identifiers

AHP-PSPRWS

Identifier Type: -

Identifier Source: org_study_id