NCT04597294RecruitingPhase 3
Prophylactic Preoperative HIPEC in Advanced Gastric Cancer at High Risk of Peritoneal Recurrence
A Randomized, Multicenter Clinical Trial Comparing the Combination of Perioperative FLOT Chemotherapy and Preoperative Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Plus Gastrectomy to Perioperative FLOT Chemotherapy and Gastrectomy Alone in Patients With Advanced Gastric Cancer at High Risk of Peritoneal Recurrence
Source: ClinicalTrials.gov · Last updated 6 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The study was designed to evaluate the efficacy of perioperative FLOT chemotherapy in combination with perioperative hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with advanced gastric cancer at high risk of peritoneal metastases. The impact of treatment on peritoneal recurrence and survival over 6 months, 1, 3 and 5 years will be assessed.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 15 Oct 2020
- Start date
- 1 Aug 2021
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- Jagiellonian University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04597294
- EudraCT number
- 2020-001419-25
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 600
- From 1 Aug 2021 to the primary completion date, 31 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous abdominal surgery (including oncological surgery), other than laparoscopic cholecystectomy or appendectomy (open or laparoscopic).
- Dysphagia requiring surgical treatment (gastric resection or nutritional jejunostomy) before starting neoadjuvant treatment and indication for accelerated surgery for other reasons.
- Disqualification for perioperative FLOT4 chemotherapy as decided by a multi-specialist consultation.
Other illness
- No clear histopathological confirmation of gastric cancer.
- Poor general condition (Performance Status 3 or more on the Eastern Cooperative Oncology Group (ECOG)/World Health Organization scale).
- Coexisting cancer in another location.
- Systemic treatment or radiotherapy for another cancer.
Age
- Age \> 75 years.
Other
- Pregnancy and lactation.
- Refusal to participate or an inability to provide written consent.
Who the study is looking for
- Gastric cancer confirmed histopathologically in tumor specimens.
- Age 18-75 years.
- Advanced gastric cancer cT3 / cT4a / N0-3b.
- No distant metastases on computed tomography (CT) scan of the chest, abdomen and pelvis (cM0).
- Written consent to participate in the study.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of General, Oncological, Gastroenterological Surgery and Transplantology Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.