Timing of pegteograstim for CINV prophylaxis

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0007694
• Lead Sponsor: Pusan National University Yangsan Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 August 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

? 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

Exclusion Criteria

? 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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of Gr4 CIN

Secondary Outcome Measures

Name	Time	Method
Incidence of Gr 3-4 CIN;Severity of CIN ;Time to recovery ANC 1000 ;Febrile neutropenia incidence;Incidence of CIN related dose delay ;Relative dose intensity ;Pegteograstim related AEs