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PIPAC and Minimally Invasive Surgery for High-Risk Gastric Cancer

This study is looking at whether a treatment called pressurized intraperitoneal chemotherapy (PIPAC) can help patients with high-risk stomach cancer (gastric adenocarcinoma). PIPAC involves delivering the drugs Cisplatin and Doxorubicin directly into the abdomen after a minimally invasive surgery to remove the stomach (D2 gastrectomy). This treatment is repeated 6-8 weeks later. The study will compare this approach to standard treatment to see if it improves how long patients live without the cancer spreading in their abdomen (peritoneal disease-free survival) after 12 months. You may be able to join if you are 18 to 80 years old and have certain types of gastric or gastroesophageal junction cancer.

Study design
This is a randomized study, meaning participants are assigned by chance to receive either the new treatment or standard care. The study plans to enroll 264 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, peritoneal disease-free survival, will be measured at 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06295094

The Efficacy of PIPAC and Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients.

Not Yet Recruiting
PHASE2Ages 18–80InterventionalPrevention
Odense University Hospital
~264 participants
Updated 2024-03-06 on ClinicalTrials.gov
What's tested:CisplatinDoxorubicin

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Peritoneal disease-free survival
Measured over 12 months

Conditions

Gastric Cancer
Chemotherapy, Adjuvant
Peritoneal Metastases
Minimally Invasive Surgical Procedures

Explore related trials

Gastric CarcinomaGastroesophageal Junction Adenocarcinoma

Where it's being run

5 sites across 5 states
California1
Denmark1
France1
Germany1
Sweden1

Study leadership

  • Michael Bau Mortensen, DMSci, PhD · STUDY_DIRECTOR · University of Southern Denmark (sdu.dk)

Who to contact

Jonas Sanberg, PhD
[email protected]
+45 20546466
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Gastric or Gastroesophageal junction Siewert type III adenocarcinomas
Clinical T3-4a-stages
Clinical T2-stage
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.

Exclusion

Previous allergic reaction to cisplatin, doxorubicin or other platinum-containing compounds.
Renal impairment, defined as glomerular filtration rate (GFR) \< 40 ml/min (Cockcroft-Gault Equation).
Myocardial insufficiency, defined as New York Heart Association (NYHA) class 3-4.
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.
Any other condition or therapy which, in the investigator's opinion, may pose a risk to the patient or interfere with the study objectives.

What this trial measures

  • Peritoneal disease-free survival12 months

    Peritoneal disease-free survival (P-DFS) defined as no signs of peritoneal recurrence on (PET) CT and/or control laparoscopy with at least 12 months follow-up after minimally invasive D2-gastrectomy