NCT06295094Not yet recruitingPhase 2
The Efficacy of PIPAC and Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients.
The Efficacy of Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC) Combined With CURativE Intent Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients. A Multicentre, Randomised, Open-label Phase-II Study
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 goal of this randomized clinical trial is to investigate whether pressurized intraperitoneal chemotherapy (PIPAC), delivered immediately after minimally invasive D2 gastrectomy and repeated 6-8 weeks later, improves 12-month peritoneal disease-free survival in patients with high-risk gastric adenocarcinoma when compared to standard treatment.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 264 (estimated)
- First submitted
- 19 Feb 2024
- Start date
- Sept 2024
- Primary completion date
- Jan 2027
- Lead sponsor
- Odense University Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06295094
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 264
- From Sept 2024 to the primary completion date, Jan 2027
- 5 sites in 5 countries
- 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 allergic reaction to cisplatin, doxorubicin or other platinum-containing compounds.
Other illness
- Myocardial insufficiency, defined as New York Heart Association (NYHA) class 3-4.
- Any other condition or therapy which, in the investigator's opinion, may pose a risk to the patient or interfere with the study objectives.
Lab values
- Renal impairment, defined as glomerular filtration rate (GFR) \< 40 ml/min (Cockcroft-Gault Equation).
- An impaired liver function, defined as bilirubin ≥ 1.5 x upper normal limit (UNL).
- An inadequate haematological function, defined as absolute neutrophil count (ANC) \<1.5 x 109/l and platelets \<100 x 109/l.
Who the study is looking for
- Gastric or Gastroesophageal junction Siewert type III adenocarcinomas
- Clinical T3-4a-stages
- Any differentiation grade
- Any histological subtype
- Clinical T2-stage
- If poorly differentiated or of the poorly cohesive histological subtype, with or without the presence of signet-ring cells
- Any clinical T-stage with positivity for malignant cells on abdominal lavage cytology, which is converted to cytology negative in response to neoadjuvant chemotherapy.
- Any clinical nodal-stage
- clinical M0-stage (positive abdominal wash cytology, which is converted to cytology negative in response to neoadjuvant therapy, is permitted)
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
- Age 18 - 80 years
- Undergoing robotic or laparoscopic D2 gastrectomy
- Able and willing to provide written informed consent and to comply with the clinical study protocol
- Fertile women must have a negative pregnancy test at the time of inclusion and must use adequate contraception.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charité, University of Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Unknown status |
| University Hospital Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.