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) |
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
Results | View publication Cancers |
For timelines and recruitment, see dashboard
REFERENZEN
FINANZIERUNGSSCHEMA
Commissioning workstream 2016