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GASTRICHIP TRIAL. D2 resection and HIPEC (Hyperthermic IntraPeritoneal Chemoperfusion) in locally advanced gastric carcinoma.
EU CTIS ID: 2024-516358-23-00
What this study is testing
Compare overall 5-year survival rates in patients surgically treated for advanced gastric adenocarcinoma (T3, T4 and/or N+ and/or with positive cytology), treated either with curative gastrectomy and adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (Arm A), or with curative gastrectomy alone (Arm B).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 18 < age ≤ 75 years old
- Histologically evidenced resectable T3 or T4 for which a curative gastrectomy is scheduled, with invasion into the serosa AND/OR lymph node metastasis (determined from data obtained by endoscopic ultrasound and chest, abdomen and pelvis CT scan) AND/OR positive peritoneal cytology (sampled during the preoperative laparoscopy).
- Females of childbearing age potential and male subjects with partners of childbearing potential using efficient contraceptive measures (as judged by the investigator).Subjects randomised in the arm with HIPEC should be informed and accept that these requirements should also extend to : * 4 months after the treatment with Oxaliplatin for female subjects, * 6 months after the treatment with Oxaliplatin for male subjects.
- White blood cells > 3,500/mm3, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3
- Good renal functions, serum creatinine values being < 1.5 mg/dl and creatinine clearance > 60 ml/min
- Performance Status ≤1, Karnofsky Index ≥ 70%
You likely can't join if
- Prior malignant tumors with detectable signs of recurrence
- Pregnancy or breastfeeding
- Females of childbearing age potential or male subjects with partners of childbearing potential not using medically accepted contraceptive measures, as judged by the investigator
- Contraindication to any drug contained in the chemotherapy regimen - Life threatening toxicity before surgery
- Distant metastases (liver, lung. ovaries, etc)
- Life threatening toxicity before surgery
See the full eligibility criteria
- 18 < age ≤ 75 years old
- Histologically evidenced resectable T3 or T4 for which a curative gastrectomy is scheduled, with invasion into the serosa AND/OR lymph node metastasis (determined from data obtained by endoscopic ultrasound and chest, abdomen and pelvis CT scan) AND/OR positive peritoneal cytology (sampled during the preoperative laparoscopy).
- Females of childbearing age potential and male subjects with partners of childbearing potential using efficient contraceptive measures (as judged by the investigator).Subjects randomised in the arm with HIPEC should be informed and accept that these requirements should also extend to : * 4 months after the treatment with Oxaliplatin for female subjects, * 6 months after the treatment with Oxaliplatin for male subjects.
- White blood cells > 3,500/mm3, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3
- Good renal functions, serum creatinine values being < 1.5 mg/dl and creatinine clearance > 60 ml/min
- Performance Status ≤1, Karnofsky Index ≥ 70%
- Serum bilirubin ≤ 2 mg/dl
- Having given written informed consent prior to any procedure related to the study
- Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research
- Not under any administrative or legal supervision Specific to the study
- Gastric adenocarcinoma and/or perforated gastric adenocarcinoma and/or Siewert III adenocarcinoma of the cardia
- Prior malignant tumors with detectable signs of recurrence
- Pregnancy or breastfeeding
- Females of childbearing age potential or male subjects with partners of childbearing potential not using medically accepted contraceptive measures, as judged by the investigator
- Contraindication to any drug contained in the chemotherapy regimen - Life threatening toxicity before surgery
- Distant metastases (liver, lung. ovaries, etc)
- Life threatening toxicity before surgery
- Tumoral infiltration of the head or body of the pancreas
- Patients presenting an adenocarcinoma of the cardia Siewert I or II
- Existence of macroscopic peritoneal implants
- Patients with clinically significant ascites (> 500 cc) even if cytology is negative for cancer cells, in the absence of other non-malignant causes of ascites
- Gastric stump adenocarcinoma
- Presence of comorbidities, notably serious chronic diseases or organ failure (ASA > 3)
- Peripheral neuropathy grade of ≥ 3 (CTC-AE V4.0) (if appropriate)
- Any subject in exclusion period of a previous study according to applicable regulations
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.