Timing of pegteograstim for CINV prophylaxis

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0007694

Enrollment

160

Registered

2022-09-15

Start date

2022-11-12

Completion date

Unknown

Last updated

2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : In the Same-day group, pegteograstim 6mg is injected subcutaneously within 4 hours after the completion of chemotherapy. While, in the Next-day arm, pegteograstim 6mg is subcutaneously injected

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Duration of Gr4 CIN	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public Contactmihyang Kim

Pusan National University Yangsan Hospital

kmhjhj1212@naver.com+82-55-360-4759

Outcome results