Ondansetron (ODF) Versus Ondansetron Intravenously for the Prevention of Chemotherapy-induced Nau… (NCT06208917) | Clinical Trial Compass
RecruitingPhase 3
Ondansetron (ODF) Versus Ondansetron Intravenously for the Prevention of Chemotherapy-induced Nausea and Vomiting Compare in Children
China376 participantsStarted 2023-07-09
Plain-language summary
The purpose is to evaluate the efficacy of ondansetron oral soluble film plus dexamethasone in preventing chemotherapy-induced nausea and vomiting (CINV) with MEC/HEC chemotherapy in children with solid tumor.
Who can participate
Age range6 Months – 18 Years
SexALL
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Inclusion criteria
✓. Children aged 6 months to 18 years at the time of randomization;
✓. Diagnosed of solid tumor by cytological or histological examination;
✓. Going to initiate MEC/HEC chemotherapy;
✓. PS score ≤ 2 points;
✓. predicted life expectancy ≥3 months and weight greater than 6Kg;
✓. Patient's parent or guardian signs informed consent
Exclusion criteria
✕. Has vomited in the 24 hours prior to chemotherapy initiation on Treatment Day 1 ;
✕. Has a symptomatic primary or metastatic central nervous system (CNS) malignancy with nausea and/or vomiting (asymptomatic participants may participate in study) ;
✕. Will be receiving stem cell rescue therapy within 14 days following administration of ondansetron ;
✕. Has experienced High emetic chemotherapy within two weeks ;
✕. Has received or will receive total body irradiation to the abdomen or pelvis in the week prior to Treatment Day 1 and/or during the diary reporting period (120 hours following initiation of chemotherapy) ;
✕. Has had benzodiazepine, opioid or opioid like therapy initiated within 48 hours prior to study drug administration, or is expected to receive within 120 hours following initiation of chemotherapy except for single doses of midazolam, temazepam or triazolam ;
What they're measuring
1
Complete Response Rate (CR rate)
Timeframe: between 0 and 24 hours after the start of chemotherapy
✕. Has started on systemic corticosteroid therapy within 72 hours prior to study drug administration or is expected to receive a corticosteroid as part of the chemotherapy regimen ;