Febrile NeutropeniaNCT03618810
Prophylactic Use of PEG-rhG-CSF in Medium-high Risk of FN in Chemotherapy of Breast Cancer
An observational study of Febrile Neutropenia, run by Zhejiang Cancer Hospital.
Trial summary
This clinical study is a multiple center, registering and real-world conditional research. The breast cancer patients planning for chemotherapy evaluated with medium-high risk of febrile neutropenia (FN) are recruited, receiving the first level prophylactic use of PEG-rhG-CSF or the second level prophylactic use of… Read more about this study
- Who is it for?
- Ages 13 to 70 years, women only
- Conditions the study is for
- Febrile Neutropenia
- What is being tested?
- PEGCSF first level prophylactic use and PEGCSF second level prophylactic use
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 70 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who undergoing chemotherapy given by prophylactic PEG-rhG-CSF using for preventing FN.
Who may be able to join
- provision of informed consent
- stage I-III, invasive breast cancer
- accept at least 4 cycles of chemotherapy
- ECOG score 0-2
- with medium-high risk of FN according to researchers
Who cannot join
- accepted stem cell or bone marrow transplant
- undergoing any other clinical trial
- uncontrolled infection, temperature≥38℃
- per-week scheme chemotherapy
- concurrent with radiotherapy
- allergic conditions
- sever organ dysfunction
- uncontrolled diabetes
Trial locations and contacts
No sites are listed yet.
Haiyan Xu, MD contact
About this study
Official title: The Effect, Safety and Pharmacoeconomics of First or Second Level-prophylactic Use of PEG-rhG-CSF in Breast Cancer Patients With Medium-high Risk of Febrile Neutropenia During Chemotherapy
This clinical study is a multiple center, registering and real-world conditional research. The breast cancer patients planning for chemotherapy evaluated with medium-high risk of febrile neutropenia (FN) are recruited, receiving the first level prophylactic use of PEG-rhG-CSF or the second level prophylactic use of PEG-rhG-CSF in at least two cycles of chemotherapy according to real-world clinical judgement and choice by physicians in local cancer center. Comparing real conditional-FN rate, FN-caused hospitalization rate and antibiotic use rate, direct/indirect medical cost.
Read the detailed description
The breast cancer patients planning for neo-adjuvant/adjuvant chemotherapy evaluated with medium-high risk of febrile neutropenia (FN) according to NCCN and ASCO guideline are recruited, receiving the first level prophylactic use of PEG-rhG-CSF or the second level prophylactic use of PEG-rhG-CSF according to real-world clinical judgement and choice by physicians in local cancer center for at least two cycles of chemotherapy. The primary outcome is FN rate, the second outcomes are rate of 3-4 grade decrease of ANC, FN-caused hospitalization, FN-caused antibiotic use rate, rate of reduction of chemotherapy dose, delay of chemotherapy, safety and pharmacoeconomics.
- Conditions
- Febrile Neutropenia
- Being tested
- PEGCSF first level prophylactic use, PEGCSF second level prophylactic use
- Keywords
- breast cancer, chemotherapy, PEG-rhG-CSF, prophylactic, febrile neutropenia
- Medical subject headings
- Febrile Neutropenia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEGCSF first level prophylactic useDrug
Also called Xin Rui Bai
6mg (≥45kg) or 3mg (<45kg) i.h. once 24h after chemotherapy in all cycles of chemotherapy
PEGCSF second level prophylactic useDrug
Also called Xin Rui Bai
6mg (≥45kg) or 3mg (<45kg) i.h. once 24h after chemotherapy in next cycle if FN or 4 grade neutropenia happened
| Study group | Role | What they receive |
|---|---|---|
| PEGCSF first level prophylactic use | The first level prophylactic use of PEG-rhG-CSF. The Prophylactic use of PEG-rhG-CSF in all cycles of chemotherapy. Receives: Drug: PEGCSF first level prophylactic use | |
| PEGCSF second level prophylactic use | The second level prophylactic use of PEG-rhG-CSF. The Prophylactic use of PEG-rhG-CSF in the next cycle until FN or 4 grade neutropenia happened. Receives: Drug: PEGCSF second level prophylactic use |
What is being measured
The primary outcome is the main question the study is designed to answer.
FN rate
rate of febrile neutropenia during all cycles of chemotherapy
Measured: assessment at 1 month after the last cycle chemotherapy complete
Secondary outcomes (4)
rate of 3-4 grade neutropenia
rate of 3-4 grade decrease of ANC
Measured: During all cycles of chemotherapy, through study completion, an average of half year
FN-caused hospitalization
rate of FN-caused hospitalization
Measured: During all cycles of chemotherapy, through study completion, an average of half year
FN-caused antibiotic use rate
rate of FN-caused antibiotic use
Measured: During all cycles of chemotherapy, through study completion, an average of half year
rate of dose reduction
rate of reduction of chemotherapy dose
Measured: During all cycles of chemotherapy, through study completion, an average of half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start20 Jan 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile NeutropeniaStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongjian Yang, MD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618810
- Sponsor's protocol ID
- RWS-PEGCSF
- Status last verified
- Dec 2018
- First submitted
- 16 Jul 2018
- Last updated
- 27 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect, Safety and Pharmacoeconomics of First or Second Level-prophylactic Use of PEG-rhG-CSF in Breast Cancer Patients With Medium-high Risk of Febrile Neutropenia During Chemotherapy
- ClinicalTrials.gov ID
- NCT03618810
- Acronym / sponsor ID
- RWS-PEGCSF
- Conditions
- Febrile Neutropenia
- Keywords
- breast cancer, chemotherapy, PEG-rhG-CSF, prophylactic, febrile neutropenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 20 Jan 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 7 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study is a multiple center, registering and real-world conditional research. The breast cancer patients planning for chemotherapy evaluated with medium-high risk of febrile neutropenia (FN) are recruited, receiving the first level prophylactic use of PEG-rhG-CSF or the second level prophylactic use of PEG-rhG-CSF in at least two cycles of chemotherapy according to real-world clinical judgement and choice by physicians in local cancer center. Comparing real conditional-FN rate, FN-caused hospitalization rate and antibiotic use rate, direct/indirect medical cost.
Detailed description
The breast cancer patients planning for neo-adjuvant/adjuvant chemotherapy evaluated with medium-high risk of febrile neutropenia (FN) according to NCCN and ASCO guideline are recruited, receiving the first level prophylactic use of PEG-rhG-CSF or the second level prophylactic use of PEG-rhG-CSF according to real-world clinical judgement and choice by physicians in local cancer center for at least two cycles of chemotherapy. The primary outcome is FN rate, the second outcomes are rate of 3-4 grade decrease of ANC, FN-caused hospitalization, FN-caused antibiotic use rate, rate of reduction of chemotherapy dose, delay of chemotherapy, safety and pharmacoeconomics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEGCSF first level prophylactic use | – | Drug: PEGCSF first level prophylactic useThe first level prophylactic use of PEG-rhG-CSF. The Prophylactic use of PEG-rhG-CSF in all cycles of chemotherapy. |
| PEGCSF second level prophylactic use | – | Drug: PEGCSF second level prophylactic useThe second level prophylactic use of PEG-rhG-CSF. The Prophylactic use of PEG-rhG-CSF in the next cycle until FN or 4 grade neutropenia happened. |
Who may qualify
- Ages
- 13 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who undergoing chemotherapy given by prophylactic PEG-rhG-CSF using for preventing FN.
Key inclusion criteria (5 listed)
- provision of informed consent
- stage I-III, invasive breast cancer
- accept at least 4 cycles of chemotherapy
- ECOG score 0-2
- with medium-high risk of FN according to researchers
Key exclusion criteria (8 listed)
- accepted stem cell or bone marrow transplant
- undergoing any other clinical trial
- uncontrolled infection, temperature≥38℃
- per-week scheme chemotherapy
- concurrent with radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEGCSF first level prophylactic useAlso: Xin Rui Bai6mg (≥45kg) or 3mg (<45kg) i.h. once 24h after chemotherapy in all cycles of chemotherapy | Drug | PEGCSF first level prophylactic use |
| PEGCSF second level prophylactic useAlso: Xin Rui Bai6mg (≥45kg) or 3mg (<45kg) i.h. once 24h after chemotherapy in next cycle if FN or 4 grade neutropenia happened | Drug | PEGCSF second level prophylactic use |
Primary outcome
FN rate
Time frame: assessment at 1 month after the last cycle chemotherapy complete
rate of febrile neutropenia during all cycles of chemotherapy
4 secondary outcomes
rate of 3-4 grade neutropenia
Time frame: During all cycles of chemotherapy, through study completion, an average of half year
FN-caused hospitalization
Time frame: During all cycles of chemotherapy, through study completion, an average of half year
FN-caused antibiotic use rate
Time frame: During all cycles of chemotherapy, through study completion, an average of half year
rate of dose reduction
Time frame: During all cycles of chemotherapy, through study completion, an average of half year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haiyan Xu, MD contact
Hongjian Yang, MD principal investigator
Zhejiang Cancer Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Febrile Neutropenia, run by Zhejiang Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongjian Yang, MD (057188122001, yhjzlyy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FN rate (time frame: assessment at 1 month after the last cycle chemotherapy complete). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2018.