Ramucirumab Plus FOLFIRI Versus Ramucirumab Plus Paclitaxel in Patients With Advanced or Metastatic Gastric Cancer, Who Failed One Prior Line of Palliative Chemotherapy
1. OS Rate at 6 months primary endpoint for phase II (Time Frame - 6 months after randomization): OS Rate at 6 months is defined at the proportion of patients being known to be alive at 6 months after randomisation
2. overall survival (OS) co-primary endpoint for phase III (Time Frame - from date of randomization to 1 year after end of treatment): duration from date of randomization to death
3. Objective Overall Response Rate (ORR) co-primary endpoint for phase III (Time Frame - from randomization for the time of treatment with a maximum of 1 year): proportion of patients with complete or partial response (CR + PR) according to RECIST 1.1
Secondary outcome:
1. Progression-free survival (Time Frame - from date of first study drug administration to up to 1 year after study completion): duration from the first study drug administration to the first documented evidence of disease progression or death
2. Overall response rate (CR + PR) - endpoint for phase II (Time Frame - from randomization for the time of treatment with a maximum of 1 year): proportion of patients with complete or partial response (CR + PR) according to RECIST 1.1
3. Disease control rate (CR + PR + SD) (Time Frame - from randomization for the time of treatment with a maximum of 1 year): proportion of patients with complete or partial response or stable disease (CR + PR + SD) according to RECIST 1.1
4. incidence and severity of adverse events according to CTC criteria (Time Frame - from randomization until 30 days after the last dose of study drug): incidence and severity of adverse events according to CTC criteria
5. Patient reported outcomes: quality of life according to questionnaire EORTC-QLQ-C30 (Time Frame - from randomization until 30 days after the last dose of study drug): quality of life scores according to validated questionnaire EORTC-QLQ-C30
Experimental: FOLFIRI plus Ramucirumab Ramucirumab 8 mg/kg i.v. infusion on day 1 and 15 of a 28-day cycle plus FOLFIRI (Irinotecan 180 mg/m2; i.v. bolus of 5-FU 400 mg/m2, i.v. infusion of leucovorin 400 mg/m2 , followed by a 46-hour continuous administration of 5-FU 2400 mg/m2 on day 1 and 15 of a 28-day cycle)
Active Comparator: Paclitaxel plus Ramucirumab Ramucirumab 8 mg/kg i.v. infusion on day 1 and 15 of a 28-day cycle plus Paclitaxel 80 mg/m2 on day 1, 8, 15
FOLFIRI: Irinotecan 180 mg/m2; i.v. bolus of 5-FU 400 mg/m2, i.v. infusion of leucovorin* 400 mg/m2 , followed by a 46-hour continuous administration of 5-FU 2400 mg/m2 on day 1 and 15 of a 28-day cycle
Ramucirumab: 8 mg/kg i.v. infusion on day 1 and 15 of a 28-day cycle
Paclitaxel: 80 mg/m2 on day 1, 8, 15
Quelle: ClinicalTrials.gov
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