|- candidate number||15679|
|- NTR Number||NTR4262|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-nov-2013|
|- Secondary IDs||836021006 projectnumber ZonMw|
|- Public Title||Perifere neuropathie als gevolg van vincristine bij kinderen met leukemie: een vergelijking van twee toedieningsvormen|
|- Scientific Title||Reducing vincristine-induced peripheral neuropathy in children with acute lymphoblastic leukemia (ALL) by one-hour infusions instead of bolus injections|
|- hypothesis||To evaluate whether the administration of vincristine (VCR) in children with acute lymphoblastic leukemia (ALL) by one-hour infusions leads to less peripheral neuropathy (PNP) compared to the administration by bolus injections. |
• To compare self-reported quality of life (QoL) associated with both administration methods.
• To compare the direct and indirect medical costs involved in both administration methods.
• To compare the treatment efficacy of both administration methods.
• To compare the pharmacokinetic parameters of patients receiving both administration methods and to relate these parameters to the degree of PNP.
• To correlate genetic factors known to be associated with VCR-induced PNP (either through influencing pharmacokinetics of VCR or through genetically increased susceptibility) to the degree of PNP of patients receiving both administration methods.
|- Healt Condition(s) or Problem(s) studied||Acute Lymfatic Leukemia (ALL), Peripheral nerve injury, Chemotherapy|
|- Inclusion criteria||- diagnosed with pediatric ALL |
- treated according to the DCOG ALL-11/ALL-12 protocol (medium and high risk patients)
|- Exclusion criteria||- younger than 2 years or older than 18 years at time of diagnosis|
- not able to comply with scheduled follow-up meausurements
- mentally retarded
- a known history of peripheral neuropathy or other pre-existing neurologic conditions before ALL diagnosis.
- patients whose parents are unable to communicate in the Dutch language.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2014|
|- planned closingdate||1-nov-2017|
|- Target number of participants||80|
|- Interventions||Group A: patients receiving all VCR administrations by bolus injections ("push injections"). |
Group B: patients receiving all VCR administrations by one-hour infusions.
|- Primary outcome||Peripheral neuropathy|
|- Secondary outcome||- Quality of life|
- Therapeutic effectiveness
|- Timepoints||Study measurements will be performed at 7 points in time: at baseline, four times during the two years of vincristine-therapy, at the end of therapy, and 6 months after the end of VCR-therapy. |
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. M.H. Berg, van den|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Gertjan J.L. Kaspers|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||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.
This study aims to investigate whether the administration of VCR in children with ALL by one-hour infusions leads to less PNP compared to bolus injections. In addition, quality of life, medical costs, and therapeutic effectiveness associated with bot 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.
The study is set up as a prospective, multi-center, randomized trial with a duration of 42 months. In the Netherlands all children diagnosed with ALL are treated according to the same treatment protocol. Patients will receive all VCR administrations of this protocol either by bolus injections or by one-hour infusions. Study measurements will be performed at 7 points in time.
|- Main changes (audit trail)|
|- RECORD||11-nov-2013 - 18-dec-2013|