KCE-16015: Vincristin-induzierte Neuropathie bei der Behandlung von krebskranken Kindern - VINCA-Studie

Zusammenfassung (Niederländisch oder Französisch oder Englisch)

 

Trial Description
Title

Vincristine geïnduceerde neuropathie bij kinderen met kanker – VINCA studie (KCE-16015)

Participants (P)

Children between 2-19 yrs, who are about to start VCR therapy for a newly diagnosed ALL treated according to the Dutch DCOG ALL-11 protocol or the Belgium EORTC-CLG 58081 guidelines or the EsPhALL protocol. In the rare cases that patients are Philadelphia chromosome positive, they will be treated according to EsPhALL protocol.

Intervention (I)

Bolus injection/infusion: VCR is administered directly or via central venous catheter into a vein. The injection/infusion should take at least 1 minute and 5 minutes at maximum.

Control (C)

One-hour infusion: VCR is continuously infused for 60 minutes through a central venous catheter

Outcome (O)

The primary outcome of the study is PNP. Secondary endpoints include quality of life and treatment efficacy.

Trial Design

The study is set up as a prospective randomized controlled trial

Sample Size

44 patients in each group (88 patients in total)

Trial duration

42 Months

Budget

€ 140 000 (incl. VAT)

Status

Closed - follow up complete

 

Trial team

Sponsor

VUmc, dep. of Paediatrics, div. of Oncology-Haematology

P.O. box 7057, 1007 MB, Amsterdam

Chief Investigator

Dr. M.H. van den Berg

VUmc, dep. of Paediatrics, div. of Oncology-Haematology

Belgian Coordinating Centre

Belgian Society for Padiatric Haematology Oncology (BSPHO)

Dokumente
Report

Expected for Q1 2020

Publication

Expected for Q1 2020

REFERENZEN

Netherlands Trial register here 

Eudra CT: 2014-001561-27

 

FINANZIERUNGSSCHEMA

Commissioning workstream 2016