Multicenter, randomized, open-label, paralled-group, active-controlled study. The study is to demonstrate non-inferiority of the Granisetron Transdermal Delivery System (GTDS) compared with the intravenous and oral Granisetron in the prevention of CINV associated with moderately emetogenic Chemotherapy. Patients scheduled to receive the one cycle of a ME chemotherapy regimen administered for 1-4 days will attend a Screening Visit 2 to 28 days before start of ME chemotherapy. Eligible patients will be randomized to 1 of 2 treatment groups at the Randomization Visit (1 to 2 days prior to ME chemotherapy). * Sancuso patch * Kytril inj.+Kytril tab. The patch will be applied 2days (48-24h) prior to first daily dose of the moderately emetogenic chemotherapy regimen and remain in place for 6 days. The patient will be assessed daily until 4days after first chemotherapy administration. Adverse Events (AEs) will be collected until 14 days after the final dose of IP. Non-serious AEs will be followed-up until 14 days after the final dose of IP. Serious adverse events will be followed-up until they are resolved, stable or until the patient is lost to follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
276
Eligible patients were randomized to Sancuso patch or Kytril groups and received the assigned treatment for 4days. Experimental arm: Sancuso patch (34.3mg) applied to upper, outer arm 2days (48-24 hours) prior to start of chemotherapy.
Eligible patients were randomized to Sancuso patch or Kytril groups and received the assigned treatment for 4days. Active Comparator arm: * Kytril inj. 3mg: administered by intravenous infusion at least 5 minutes, just before the first chemotherapy (Day 1). * Kytril tab. 1mg: administered twice a day by orally at Day 2\~4.
Samsung Medical Center
Seoul, South Korea
RECRUITINGThe percentage of patients achieving Complete Response (CR) without rescue therapy from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
Time frame: from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
The percentage of patients achieving Complete Response (CR)
Time frame: overall (Day 1~4)
The percentage of patients achieving Complete Control (CC) without rescue therapy from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
Time frame: from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
The percentage of patients achieving Complete Control (CC)
Time frame: overall (Day 1~4)
severity of nausea
Time frame: overall (Day 1~4)
severity of vomiting
Time frame: overall (Day 1~4)
Frequency of nausea from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
Time frame: from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
Frequency of vomiting from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
Time frame: from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
Patient's satisfaction with anti-emetic therapy (Changes from Baseline to Day 5)
The patient's response to anti-emetic therapy was assessed and recorded by patients at Visit 3 (Baseline) and Visit 7 (Day 5). The patient was asked to evaluate his/her satisfaction with the control of nausea and vomiting by marking the FLI-E (Functional Living Index - Emesis) with vertical lines.
Time frame: from baseline to Day 5
The percentage of patients achieving Complete Response (CR)
Time frame: per day (Day 1, 2, 3, 4)
The percentage of patients achieving Complete Control (CC)
Time frame: per day (Day 1, 2, 3, 4)
severity of nausea
Time frame: per day (Day 1, 2, 3, 4)
severity of vomiting
Time frame: per day (Day 1, 2, 3, 4)
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