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Preoperative intraperitoneal chemotherapy in adjuvant hyperthermia adjunctive therapy in advanced gastric cancer with high-risk of peritoneal recurrence - a multicentre randomized trial.
EU CTIS ID: 2024-516042-18-00
What this study is testing
To evaluate the effectiveness of perioperative FLOT4 chemotherapy in combination with preoperative intraperitoneal chemotherapy for hyperthermia (HIPEC) in patients with advanced gastric cancer at high risk of metastases to the peritoneal cavity - the main aim of the study is to reduce the frequency of peritoneal recurrences 6 months after gastrectomy compared to the group of patients treated without HIPEC.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- gastric cancer confirmed in histological examination of material taken during gastroscopy and biopsy of the tumour
- advanced gastric cancer (cT3/T4a, cN0-3b)
- no distant metastases on chest, abdominal and pelvic computed tomography (cM0)
- age 18-75
- signed written informed consent
- completion of at least 3 cycles of preoperative FLOT chemotherapy
You likely can't join if
- lack of confirmation of gastric cancer in histologic examination of biopsy material taken during gastroscopy
- age > 75
- Performance status 3 or higher in ECOG/WHO scale
- previous abdominal surgery other than appendectomy or laparoscopic cholecystectomy
- pregnancy or lactation
- lack of written informed consent
See the full eligibility criteria
- gastric cancer confirmed in histological examination of material taken during gastroscopy and biopsy of the tumour
- advanced gastric cancer (cT3/T4a, cN0-3b)
- no distant metastases on chest, abdominal and pelvic computed tomography (cM0)
- age 18-75
- signed written informed consent
- completion of at least 3 cycles of preoperative FLOT chemotherapy
- lack of confirmation of gastric cancer in histologic examination of biopsy material taken during gastroscopy
- age > 75
- Performance status 3 or higher in ECOG/WHO scale
- previous abdominal surgery other than appendectomy or laparoscopic cholecystectomy
- pregnancy or lactation
- lack of written informed consent
- other simultaneous neoplasm
- previous systemic treatment or radiotherapy for other neoplasm
- serious dysfagia requiring surgical treatment before previous chemotherapy
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.