NCT04905329Unknown不适用
Defendor Special: A Multicenter Prospective Observational Post-registration Study of Combined Chemotherapy With Empegfilrastim Support to Evaluate Safety and Efficacy in Patients With High and "Gray Zone" Risk Reccurrence Breast Cancer, Gastointestinal Cancers and Gynecological Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 285
- 试验地点
- 3
- 主要终点
- Relative dose-intensity (RDI) of the myelosupressive therapy course
研究概览
简要总结
This study was designed to evaluate the efficacy and safety of Extimia® (INN - empegfilgrastim) in reducing the frequency, duration of neutropenia, the incidence of febrile neutropenia and infections caused by febrile neutropenia in patients with High and "Gray Zone" Risk Reccurrence Breast Cancer, Gastointestinal Cancers and Gynecological Malignancies
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form;
- •Histologically verified diagnosis;
- •Age between 18 and 80 years; If the patient had previously received chemotherapy for these indications, then it should be completed at least 30 days before the first administration of the study drug;
- •ECOG performance 0-2;
- •Haematology:
- •ANC ≥ 1,5 х 10(9) /L;
- •Platelets ≥ 100 х 10(9) /L;
- •Hemoglobin ≥ 90 g/L;
- •Biochemistry:
- •Creatinine ≤ 1,5 ULN;
- •Total bilirubin ≤ 1,5 ULN;
- •AST/ALT ≤ 2,5 ULN;
- •Alkaline phosphatase ≤ 5 ULN;
- •Life expectancy of at least 6 months from the date of the first drug administration in the study;
- •Ability of the patient to comply with the Protocol requirements.
排除标准
- •Documented hypersensitivity to empegfilgrastim, filgrastim, pegfilgrastim, and / or their constituent excipients: pegylated drugs, protein recombinant drugs;
- •Systemic use of antibiotics less than 72 hours before the first drug administration in the study;
- •Concurrent or less than 30 days before the start of the study, radiation therapy (with the exception of point radiation therapy for bone metastases); study;
- •Concurrent participation in clinical trials, participation in clinical trials within the previous 30 days, previous participation in this study;
- •Surgical treatment less than 21 days (3 weeks) prior to study enrollment; taking any experimental medications less than 30 days before enrollment in this study;
- •History of bone marrow or hematopoietic stem cell transplantation;
- •Presence of acute or active chronic infections;
- •Other diseases (with the exception of the main one) that could affect the assessment of the severity of the symptoms of the underlying disease: that may mask, enhance, change the symptoms of the underlying disease or cause clinical manifestations and changes in the data of laboratory and instrumental research methods;
- •Inability to administer the drug by intravenous infusion or subcutaneous injection.
研究组 & 干预措施
Patients with high and "gray zone" risk reccurrence early breast cancer
干预措施: Empegfilgrastim (Drug)
Patients with gastointestinal cancers
干预措施: Empegfilgrastim (Drug)
Patients with gynecological malignancies
干预措施: Empegfilgrastim (Drug)
结局指标
主要结局
Relative dose-intensity (RDI) of the myelosupressive therapy course
时间窗: 12 months
次要结局
- RDI of FOLFOX-, FOLFOXIRI-based regimens performed in relation to (neo) adjuvant therapy of colorectal cancer(18 months)
- RDI of 6 x TC, 6 x TCHP, ddAC x4 -> 4 x paclitaxel , dd4AC -> 4 x paclitaxel + 12 x carboplatin) regimens performed in relation to (neo) adjuvant therapy of breast cancer(18 months)
- RDI of FOLFOX-, FOLFOXIRI-based regimens performed in relation to patients with potentially resectable liver metastases of colorectal cancer(18 months)
- RDI of DCF-, FOLFORINOX-based regimens performed in relation to therapy of pancreatic cancer(18 months)
- RDI of DCF-, FOLFORINOX-, FLOT-, FOLFOX-based regimens performed in relation to therapy of gastric and esophageal cancers(18 months)
- The incidence of severe infections (grade 3-4)(18 months)
- Serious adverse events frequency(18 months)
- RDI of chemotherapy courses performed in patients with cervical cancer and sarcoma of the uterus after irradiation of the pelvic organs(18 months)
- Frequency of study withdrawal due to adverse events(18 months)
- RCB rate in patients with breast cancer(18 months)
- The complete pathological responses (pCR) rate in the primary tumors for patients diagnosed with HER2 + and triple negative early breast cancer requiring neoadjuvant treatment(18 months)
- The complete pathological responses (pCR) rate in the malignant lymph nodes for patients diagnosed with HER2 + and triple negative early breast cancer requiring neoadjuvant treatment(18 months)
- The incidence of febrile neutropenia with empegfilgrastim supportive therapy compared with historical control(18 months)
- Frequency of antibiotic prescription(18 months)
- The incidence of neutropenia leading to a dose reduction of cytostatic drugs and / or an increase of the interval between cycles when using empegfilgrastim supportive therapy compared with historical controls(18 months)
- Completed cases number of (neo) adjuvant therapy(18 months)
- Any grade adverse events frequency(18 months)
研究者
Zhukova Lyudmila
Deputy Director of the Loginov Moscow Clinical Scientific Center, MD, PhD, Professor
Moscow Clinical Scientific Center
研究点 (3)
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