CISPLATIN for Gastric adenocarcinoma

Inclusion criteria

• {"criterion_text":"- Gastric or GE junction Siewert type III adenocarcinomas (by pre-inclusion biopsy)"}
• {"criterion_text":"- Able and willing to provide written informed consent in site local language or English, and to comply with the clinical study protocol"}
• {"criterion_text":"- Fertile women must have a negative pregnancy test at the time of inclusion and must use adequate contraception at inclusion and until at least three months after"}
• {"criterion_text":"- cT3-4a for any differentiation grade and histological subtype"}
• {"criterion_text":"- cT2 if poorly differentiated or of the poorly cohesive histological subtype, with or without the presence of signet-ring cells"}
• {"criterion_text":"- Any cT with positivity for malignant cells on abdominal lavage cytology at pre-inclusion diagnostic laparoscopy, which is converted to cytology negative at separate laparoscopy in response to neoadjuvant chemotherapy"}
• {"criterion_text":"- Any cN"}
• {"criterion_text":"- cM0 (positive abdominal wash cytology at pre-inclusion diagnostic laparoscopy, which is converted to cytology negative at separate laparoscopy in response to neoadjuvant therapy, is permitted)"}
• {"criterion_text":"- Performance status ECOG 0-1"}
• {"criterion_text":"- Age 18 – 80 years"}
• {"criterion_text":"- Undergoing robotic or laparoscopic D2 gastrectomy"}

Exclusion criteria

• {"criterion_text":"- Previous allergic reaction to cisplatin, doxorubicin or other platinum-containing compounds"}
• {"criterion_text":"- Renal impairment, defined as GFR < 40 ml/min (Cockcroft-Gault Equation)."}
• {"criterion_text":"- Myocardial insufficiency, defined as NYHA class 3-4"}
• {"criterion_text":"- An impaired liver function, defined as bilirubin ≥ 1.5 x UNL (upper normal limit)."}
• {"criterion_text":"- An inadequate haematological function, defined as ANC<1.5 x 109/l and platelets <100 x 109/l."}
• {"criterion_text":"- Any other condition or therapy which, in the investigator’s opinion, may pose a risk to the patient or interfere with the study objectives"}

Primary endpoints

• {"endpoint_text":"- Peritoneal disease-free survival (P-DFS) defined as no signs of peritoneal recurrence on PET-CT/CT and diagnostic laparoscopy with at least 12 months follow-up after minimally invasive D2-gastrectomy","definition_or_measurement_approach":"No signs of peritoneal recurrence on PET-CT/CT and diagnostic laparoscopy with at least 12 months follow-up after minimally invasive D2-gastrectomy"}

Secondary endpoints

• {"endpoint_text":"- Disease-free survival (DFS) with at least 12 months of follow-up (through electronic patient records up to five years after surgery)","definition_or_measurement_approach":"DFS assessed with at least 12 months follow-up, data collected via electronic patient records up to five years after surgery"}
• {"endpoint_text":"- Overall survival with at least 12 months of follow-up (through electronic patient records up to five years after surgery)","definition_or_measurement_approach":"Overall survival assessed with at least 12 months follow-up, data collected via electronic patient records up to five years after surgery"}
• {"endpoint_text":"- Length of stay (LOS) (Surgery = Day 0)","definition_or_measurement_approach":"Hospital length of stay measured from day of surgery (Day 0)"}
• {"endpoint_text":"- 30 days postoperative toxicity (CTCAE)","definition_or_measurement_approach":"Postoperative toxicity within 30 days graded by CTCAE"}
• {"endpoint_text":"- 30 days postoperative complications (Dindo-Clavien)","definition_or_measurement_approach":"Postoperative complications within 30 days classified by Dindo-Clavien"}
• {"endpoint_text":"- 90 days mortality","definition_or_measurement_approach":"All-cause mortality within 90 days postoperatively"}
• {"endpoint_text":"- Rate of positive peritoneal lavage","definition_or_measurement_approach":"Proportion of patients with positive peritoneal lavage cytology"}
• {"endpoint_text":"- Quality of life (EORTC QLQ-C30 + QLC-STO22)","definition_or_measurement_approach":"Quality of life measured using EORTC QLQ-C30 and QLQ-STO22 questionnaires"}
• {"endpoint_text":"- The rate of included patients not receiving adjuvant chemotherapy as planned due to PIPAC-related complications","definition_or_measurement_approach":"Proportion of included patients who do not receive planned adjuvant chemotherapy because of PIPAC-related complications"}

Denmark

Earliest CTIS Part Ii Submission Date

06-06-2025

Latest Decision Or Authorization Date

23-06-2025

Processing Time Days

17

Number Of Sites

1

Number Of Participants

41

France

Earliest CTIS Part Ii Submission Date

03-06-2025

Latest Decision Or Authorization Date

23-06-2025

Processing Time Days

20

Number Of Sites

1

Number Of Participants

41

Sweden

Earliest CTIS Part Ii Submission Date

01-04-2025

Latest Decision Or Authorization Date

23-06-2025

Processing Time Days

83

Number Of Sites

1

Number Of Participants

41

Primary sponsor

Full Name

Odense University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"Codes: 1,7,8","organisation_type":"Hospital/Clinic/Other health care facility"}