COmparisoN of prophylactic effects for Chemotherapy Induced neutropenia between SamE-day versus next-day administration of pegteograstim in patients treated with chemotherapy regimen composed of day 1 intensive myleosuppressive agent: A randomized phase III clinical trial

Pusan National University Yangsan Hospital0 个研究点目标入组 160 人开始时间: 待定最近更新: 2023年8月1日

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•? Patients with histologically diagnosed cancer who are scheduled to undergo adjuvant (neo-adjuvant) or 1st line palliative chemotherapy using the following multi-day combined chemotherapy. (However, for FOLFOX and FOLFIRI therapy, combination therapy with targeted anticancer drugs such as cetuximab or avastin can also be allowed)
•mFOLFIRINOX (Pancreatic cancer)
•ECb, EP (Small cell carcinoma, Neuroendocrine carcinoma)
•FOLFIRI, FOLFOX (Colon)
•? Patients with one or more patient-related CIN risk factors (previous chemotherapy or radiotherapy, recent surgery and open wound, liver/kidney dysfunction, 65 years of age or older) You can register without a factor).
•? 100% dose will be adminstered
•? Patients aged 19 to 75 years
•? ECOG PS 0-1
•? Adequate bone marrow function to receive chemotherapy (absolute neutrophil count =1500/µl), platelets = 100,000/mm2 (= 100 x 109/L), and hemoglobin = 9.0 g/dL), and adequate renal function (creatinine clearance) = 40 mL/min), adequate liver function (total bilirubin in blood < 1.5 x ULN, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 3.0 x ULN, or = 5.0 x in subjects with documented liver metastasis) ULN) patient
•? When the signed test subject consent form has been obtained

•? Patients over 76 years of age
•? Patients who have difficulty applying 100% dose intensity
•? Patients who received radiation therapy within 1 month before starting treatment
•? Other serious illness or medical condition
•? Pregnant or lactating women or women of childbearing potential who do not consider appropriate contraception

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