Intraperitoneal irinotecan combined with systemic therapy for patients with gastric peritoneal metastases: A phase II, multicenter study

Conditions

Gastric peritoneal metastases

Brief summary

Feasibility, determined as the percentage of patients completing all cycles of systemic therapy in combination with intraperitoneal irinotecan

Detailed description

Overall survivall, calculated from date of PM until death or last follow-up, Safety of the administered treatment, assessed by all treatment-related AEs, all SAEs, percentage of patients discontinuing treatment due to treatment-related AEs, Overall respons rate of iriotecan in combination with systemic therapy for patients with PM of GC, assessed by the percentage of patients demonstrating response of the the treatment, Progression-free survival calculated from date of PM until progression or last follow-up, QoL at baseline, after the first cycle, after the first radiological response evaluation, and after the last cycle, assessed by: EQ-5D-5L,QLQ-C30 and QLQ-STO22., Healthcare costs and costs due to productivity losses during and after treatment with IP irinotecan in combination with systemic therapy for patients with PM of GC assessed by questionnaires

Related papers

No related papers found yet.

Interventions

DRUGIrinotecan Accord 20 mg/ml concentraat voor oplossing voor infusie

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Feasibility, determined as the percentage of patients completing all cycles of systemic therapy in combination with intraperitoneal irinotecan	—

Secondary

Measure	Time frame
Overall survivall, calculated from date of PM until death or last follow-up, Safety of the administered treatment, assessed by all treatment-related AEs, all SAEs, percentage of patients discontinuing treatment due to treatment-related AEs, Overall respons rate of iriotecan in combination with systemic therapy for patients with PM of GC, assessed by the percentage of patients demonstrating response of the the treatment, Progression-free survival calculated from date of PM until progression or last follow-up, QoL at baseline, after the first cycle, after the first radiological response evaluation, and after the last cycle, assessed by: EQ-5D-5L,QLQ-C30 and QLQ-STO22., Healthcare costs and costs due to productivity losses during and after treatment with IP irinotecan in combination with systemic therapy for patients with PM of GC assessed by questionnaires	—

Measure

Time frame

Overall survivall, calculated from date of PM until death or last follow-up, Safety of the administered treatment, assessed by all treatment-related AEs, all SAEs, percentage of patients discontinuing treatment due to treatment-related AEs, Overall respons rate of iriotecan in combination with systemic therapy for patients with PM of GC, assessed by the percentage of patients demonstrating response of the the treatment, Progression-free survival calculated from date of PM until progression or last follow-up, QoL at baseline, after the first cycle, after the first radiological response evaluation, and after the last cycle, assessed by: EQ-5D-5L,QLQ-C30 and QLQ-STO22., Healthcare costs and costs due to productivity losses during and after treatment with IP irinotecan in combination with systemic therapy for patients with PM of GC assessed by questionnaires

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Countries

Netherlands

Outcome results

None listed