Real World Study of PEG-rhG-CSF in Prevention of Chemotherapy-induced Neutropenia
2019년 2월 18일 업데이트: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Real World Study of PEGylated Recombinant Human Granulocyte Stimulating Factor(PEG-rhG-CSF) in Prevention of Chemotherapy-induced Neutropenia
The aim of this study is to observe and evaluate the cost-effectiveness,efficacy and safety of PEG-rhG-CSF in preventing chemotherapy-induced neutropenia(CIN) of cancer patients in the real world.1000
patients with non-myeloid malignancy who is planned to receive PEG-rhG-CSF for CIN prevention and 500 patients with non-myeloid malignancy who is planned to receive rhG-CSF for CIN prevention or treatment were prospectively recruited.The primary outcome was cost-effectiveness and second outcome was febrile neutropenia,the incidence and duration of grade IV neutropenia,chemotherapy delay,incidence of reduced dose of chemotherapy and relative dose intensity of chemotherapy.
연구 개요
연구 유형
관찰
등록 (예상)
1500
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
1000 patients with non-myeloid malignancy who is planned to receive PEG-rhG-CSF for CIN prevention and 500 patients with non-myeloid malignancy who is planned to receive rhG-CSF for CIN prevention or treatment were prospectively recruited.
설명
Inclusion Criteria:
- Patients' age≥18 years old, male or female
- Diagnosis of non-myeloid malignant solid tumors
- Patients are planned to perform chemotherapy and preventive use the PEG-rhG-CSF or preventive or therapeutic use of rhG-CSF after chemotherapy
- Patients' mental status are well, could understand the study and willing to participate the study, sign the informed consent form
- The investigator believes that patients can benefit from this study
Exclusion Criteria:
- Patients who have been confirmed to be allergic to Jinyouli® or rhG-CSF or its excipients
- Pregnant or lactating women and women who plan to be pregnant during clinical observation
- Other patients that the doctor believe not suitable for inclusion
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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PEG-rhG-CSF group
This group comprised 1000 patients who received a single subcutaneous injection of PEG-rhG-CSF 24 hours after the end of chemotherapy for each chemotherapy cycle.
The dose of PEG-rhG-CSF is determined by the patients' body weight, patients with body weight ≥45 kg is given to PEG-rhG-CSF 6 mg each time, patients<45 kg is given to PEG-rhG-CSF 3 mg each time.
|
PEG-rhG-CSF was administered 24 hours after the end of chemotherapy for each chemotherapy cycle.
다른 이름들:
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rhG-CSF group
This group comprised 500 patients who received rhG-CSF 5 μg/kg/day by subcutaneous injection 24 hours after the end of chemotherapy or the appearance of CIN until the ANC was ≥2.0x109/L for each chemotherapy cycle.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cost-Effectiveness
기간: through the chemotherapy cycles of PEG-rhG-CSF or rhG-CSF treatment,an average of 3 month
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Based on the results of the incidence of febrile neutropenia(FN) and the cost perFN in each group, the incremental cost-effectiveness ratio were estimated using the following formula: (CostA-CostB)/(OutcomeA-OutcomeB)
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through the chemotherapy cycles of PEG-rhG-CSF or rhG-CSF treatment,an average of 3 month
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The incidence of febrile neutropenia
기간: From date of randomization until the date of the study completion,an average of 3 month
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Febrile neutropenia (FN) is defined as oral temperature >38.3 ℃(under arm temperature >38.1 ℃) or continuous measurement of oral temperature >38℃(under arm temperature >37.8℃) in 2h, and absolute neutrophil count(ANC) <0.5×10^9/L, or expected to be <0.5×10^9/L
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From date of randomization until the date of the study completion,an average of 3 month
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The incidence of grade IV neutropenia
기간: From date of randomization until the date of the study completion,an average of 3 month
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Grade IV neutropenia is defined as the absolute neutrophil count(ANC)<0.5×10^9/L
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From date of randomization until the date of the study completion,an average of 3 month
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The duration of grade IV neutropenia in every chemotherapy cycle
기간: From date of randomization until the date of the study completion,an average of 3 month
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Defined as days when the ANC<2.0×10^9/L
occurs to the time when the ANC≥2.0×10^9/L,
take the median
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From date of randomization until the date of the study completion,an average of 3 month
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The incidence of the chemotherapy delay
기간: From date of randomization until the date of the study completion,an average of 3 month
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Chemotherapy delay is defined as the delay in starting the next planned chemotherapy for more than 3 days.
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From date of randomization until the date of the study completion,an average of 3 month
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The duration of the chemotherapy delay in every chemotherapy cycle
기간: From date of randomization until the date of the study completion,an average of 3 month
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The duration of the chemotherapy delay in every chemotherapy cycle
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From date of randomization until the date of the study completion,an average of 3 month
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The incidence of the dose reduction
기간: From date of randomization until the date of the study completion,an average of 3 month
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The incidence of the reduction of planned dose of chemotherapy
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From date of randomization until the date of the study completion,an average of 3 month
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Relative chemotherapy dose intensity in every chemotherapy cycle
기간: From date of randomization until the date of the study completion,an average of 3 month
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Relative chemotherapy dose intensity is defined as the actual chemotherapy dose the patient used divided by the planned chemotherapy dose,or the actual chemotherapy time divided by the planned chemotherapy time
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From date of randomization until the date of the study completion,an average of 3 month
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of adverse events
기간: From date of randomization until the date of the study completion,an average of 3 month
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All adverse events will be recorded from the time of patients signing the informed consent form up to 30 days after the last Intervention drug is applied.
the adverse event that associated with the study drug will be specially recorded.
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From date of randomization until the date of the study completion,an average of 3 month
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (예상)
2019년 2월 13일
기본 완료 (예상)
2020년 4월 1일
연구 완료 (예상)
2020년 10월 1일
연구 등록 날짜
최초 제출
2019년 2월 14일
QC 기준을 충족하는 최초 제출
2019년 2월 18일
처음 게시됨 (실제)
2019년 2월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 2월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 2월 18일
마지막으로 확인됨
2019년 2월 1일
추가 정보
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