Vincristine-Induced Neuropathy in Children with Cancer - VINCA study (KCE-16015)

Summary (French or English)

Vincristine (VCR) is a commonly used chemotherapeutic drug in the treatment of pediatric acute lymphoblastic leukemia (ALL). The main dose-limiting side effect of VCR is peripheral neuropathy (PNP). PNP is often seen in the form of weakness of lower limbs, areflexia, neuropathic pain, and/or sensory loss. The quality of life of children who suffer from VCR-induced PNP is severely affected.

There is a lack of information regarding the optimal therapeutic dosing and method of administration of VCR for children with cancer. High peak plasma concentrations seem to be correlated with PNP. However, the exact mechanism underlying VCR-induced PNP is not clear.

The study is set up as a prospective, multi-center, open-label, randomized controlled trial with a duration of 42 months. A total of 88 patients will be included in the Netherlands and in Belgium.

Patients who participate in the current trial will receive all VCR administrations either by bolus injections/infusions (1-5 minutes) or by one-hour infusions. Study measurements will be performed at 7 points in time.

This study aims to investigate whether the administration of VCR in children with ALL by one-hour infusions, resulting in lower peak plasma concentrations, leads to less PNP compared to bolus injections/infusions. In addition, quality of life and treatment efficacy associated with both administration methods will be evaluated. Moreover, it will be investigated whether other factors, such as pharmacokinetics and genetic susceptibility to drug-induced side-effects, also influence the degree of PNP.

Recruitment for this trials is complete. Results are expected by mid 2019.

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

Recruitment complete

FPI DEC 2017

 

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)

Documents
Protocol  
Report

Expected for Q2 2019

Publication

Expected for Q3 2019

References

Netherlands Trial register here 

EudraCT: 2014-001561-27

Webpage: 

Funding scheme

Commissioning workstream 2016