NCT04597294 Prophylactic Preoperative HIPEC in Advanced Gastric Cancer at High Risk of Peritoneal Recurrence
| NCT ID | NCT04597294 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Jagiellonian University |
| Condition | Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2021-08-01 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 600 participants in total. It began in 2021-08-01 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * No clear histopathological confirmation of gastric cancer. * Age \> 75 years. * Poor general condition (Performance Status 3 or more on the Eastern Cooperative Oncology Group (ECOG)/World Health Organization scale). * Previous abdominal surgery (including oncological surgery), other than laparoscopic cholecystectomy or appendectomy (open or laparoscopic). * Pregnancy and lactation. * Refusal to participate or an inability to provide written consent. * Coexisting cancer in another location. * Systemic treatment or radiotherapy for another cancer. * 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.
Contact & Investigator
Piotr Richter, Professor
STUDY DIRECTOR
Jagiellonian University
Frequently Asked Questions
Who can join the NCT04597294 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04597294 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 600 participants.
Is NCT04597294 currently recruiting?
Yes, NCT04597294 is actively recruiting participants. Contact the research team at piotr.richter@uj.edu.pl for enrollment information.
Where is the NCT04597294 trial being conducted?
This trial is being conducted at Krakow, Poland.
Who is sponsoring the NCT04597294 clinical trial?
NCT04597294 is sponsored by Jagiellonian University. The principal investigator is Piotr Richter, Professor at Jagiellonian University. The trial plans to enroll 600 participants.
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