Randomised Phase III Trial of First Line Intraperitoneal Paclitaxel and Systemic Therapy versus Systemic Therapy Alone in Gastric Cancer Patients with Peritoneal Metastases

Conditions

Gastric cancer

Brief summary

Overall survival (OS), defined as time from randomisation to death from any cause.

Detailed description

Toxicity/adverse Events (AE) according to CTCAE v5.0 in patients treated with IP paclitaxel., HRQoL assessed using EORTC QLQ-C30 and EORTC OG-25 during treatment and follow-up., Progression-free survival (PFS), defined as time from randomisation to first documentation of progression according to RECIST1.1, progression of peritoneal carcinomatosis index (PCI), radiological progression of ascites, need for drainage of ascites or death, whichever occurs first., Radiological response of treatment on ascites present at baseline., Quantifying the amount of ascites drained from the randomisation date to date of censoring, death or end of study., Proportion of patients in each study arm, 1. Fulfilling the criteria for, 2. Undergoing, curative intent conversion surgery.

Related papers

No related papers found yet.

Interventions

DRUGNIVOLUMAB

DRUGCAPECITABINE

DRUGPACLITAXEL

DRUGDOCETAXEL

DRUGFLUOROURACIL

DRUGTRASTUZUMAB

DRUGPEMBROLIZUMAB

DRUGZOLBETUXIMAB

DRUGOXALIPLATIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival (OS), defined as time from randomisation to death from any cause.	—

Secondary

Measure	Time frame
Toxicity/adverse Events (AE) according to CTCAE v5.0 in patients treated with IP paclitaxel., HRQoL assessed using EORTC QLQ-C30 and EORTC OG-25 during treatment and follow-up., Progression-free survival (PFS), defined as time from randomisation to first documentation of progression according to RECIST1.1, progression of peritoneal carcinomatosis index (PCI), radiological progression of ascites, need for drainage of ascites or death, whichever occurs first., Radiological response of treatment on ascites present at baseline., Quantifying the amount of ascites drained from the randomisation date to date of censoring, death or end of study., Proportion of patients in each study arm, 1. Fulfilling the criteria for, 2. Undergoing, curative intent conversion surgery.	—

Measure

Time frame

Toxicity/adverse Events (AE) according to CTCAE v5.0 in patients treated with IP paclitaxel., HRQoL assessed using EORTC QLQ-C30 and EORTC OG-25 during treatment and follow-up., Progression-free survival (PFS), defined as time from randomisation to first documentation of progression according to RECIST1.1, progression of peritoneal carcinomatosis index (PCI), radiological progression of ascites, need for drainage of ascites or death, whichever occurs first., Radiological response of treatment on ascites present at baseline., Quantifying the amount of ascites drained from the randomisation date to date of censoring, death or end of study., Proportion of patients in each study arm, 1. Fulfilling the criteria for, 2. Undergoing, curative intent conversion surgery.

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Countries

Italy, Netherlands, Norway, Sweden

Outcome results

None listed