The most common site for gastric cancer distant metastases is the peritoneum. Median survival for this group of patients is short and systemic cytotoxic treatment response is poor, partly due to the low uptake of the treatment compounds to the peritoneum during systemic chemotherapy. Infusion of cytotoxic drugs directly into the abdominal cavity has been shown to have a high objective response rate and low toxicity. The IPa-Gastric trial is an open-label, multicentre, randomised, phase-III study in the first line setting in gastric cancer patients with peritoneal metastases. Patients will receive the study treatments until disease progression, unacceptable side effects, the investigator's decision to end treatment for other reasons, death, or end of study. After discontinuing study treatments, each patient will be followed up for all study endpoints that are clinically feasible, until death or end of study. The primary objective is to compare overall survival (OS) for patients randomised to intraperitoneal (IP) paclitaxel and standard ST versus those randomised to standard ST only.
Gastric or gastro-oesophageal junction Siewert type II or III adenocarcinoma verified by biopsy or cytology from the primary tumour
Peritoneal metastasis verified by biopsy, or cytology from ascites or peritoneal wash fluid
Staging laparoscopy with assessment of peritoneal cancer index (PCI) performed less than four weeks before enrolment.
Patients with tumour positive cytology (CYT+) without clinically manifest peritoneal metastases at baseline (PCI 0) staging laparoscopy can be included if they persist to be CYT+ after at least four cycles of systemic chemotherapy.
Comorbidity that does not allow treatment with ST or IP paclitaxel
Confirmed or suspected severe abdominal adhesions
Severe coagulation disorder which precludes surgical interventions
Distant metastases (including M1 lymph node metastases) other than peritoneal, with the specific exception of ovarian metastases
Parallel
Intraperitoneal Paclitaxel
DrugIntraperitoneally administered Paclitaxel
Standard systemic therapy
DrugStandard investigator's choice therapy with systemic chemotherapy and any targeted therapies indicated in the standard clinical practice setting
Overall survival (OS)
Overall survival (OS), defined as time from randomisation to death from any cause. For subjects who are still alive at the End of Study (EoS), or who are lost to follow up, OS time will be censored at the last recorded date that the subject was known to be alive.
Treatment-related toxicity
Incidence of Adverse Events (AE) as assessed by CTCAE v5.0
General Health Related Quality of Life (HR QoL)
General Health Related Quality of Life (HR QoL) as measured by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire QLQ-C30. Two types of scores will be calculated: raw scores and linearly transformed scores.
Progression free survival (PFS)
PFS is 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.
Observed and change from baseline values will be summarized descriptively at planned visits by treatment. A mixed-effects model repeated measures (MMRM) analysis will evaluate longitudinal change from baseline. The baseline score will be included as a covariate.
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Magnus Nilsson
Lead sponsor
Karolinska University Hospital
Sponsor institution
