Surgery and chemotherapy for gastric cancer with spread in the abdomen
Treatment of Peritoneal Dissemination in Stomach Cancer Patients With Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC).
PHASE3 · The Netherlands Cancer Institute · NCT03348150
This study is testing whether a combination of surgery and a special type of chemotherapy can help people with advanced stomach cancer live longer compared to standard chemotherapy alone.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 182 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Netherlands Cancer Institute (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT03348150 on ClinicalTrials.gov |
What this trial studies
This phase III trial investigates the effectiveness of combining gastrectomy, cytoreductive surgery, and hyperthermic intraperitoneal chemotherapy (HIPEC) for patients with gastric cancer that has spread to the peritoneum. Participants will be randomly assigned to either the experimental treatment group or the standard palliative systemic chemotherapy group. The study aims to determine if the combination of these surgical and chemotherapy approaches can improve overall survival compared to standard treatment. The rationale is based on the potential for direct delivery of high concentrations of chemotherapy to the affected area, minimizing systemic toxicity.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with biopsy-proven gastric adenocarcinoma and limited peritoneal carcinomatosis.
Not a fit: Patients with extensive peritoneal carcinomatosis or those who are not candidates for surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients with gastric cancer and peritoneal dissemination.
How similar studies have performed: Previous studies in Asia have shown promising results with similar approaches, but this trial aims to evaluate the effectiveness in a Western population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Biopsy proven primary adenocarcinoma (or undifferentiated carcinoma) of the stomach. Including tumours at the oesophagogastric junction provided that the bulk of the tumour is located in the stomach, and, the intended surgical treatment is a gastric resection and not an oesophagectomy. A high intra-thoracic anastomosis is allowed, but not if a thoracotomy is necessary. * cT3-cT4 tumour (TNM classification, 7th edition), considered to be resectable (including lymph nodes) * Limited peritoneal carcinomatosis (PCI \<7) and/ or tumour positive peritoneal cytology confirmed by laparoscopy or laparotomy and proven by pathological examination * Treatment with systemic chemotherapy, with the latest course ending within 8 weeks prior to inclusion. All currently standard chemotherapy regimens are acceptable * Absence of disease progression during systemic chemotherapy (prior to inclusion) * WHO performance status 0-2 * Adequate bone marrow, hepatic and renal function. Minimally acceptable laboratory values at start of the study inclusion: * ANC ≥ 1.5 x 109 /L * Platelet count ≥ 100 x 109 /L * Serum bilirubin ≤ 1.5 x ULN, and ALAT and ASAT ≤ 2.5 x ULN * Creatinine clearance ≥ 50 ml/min (measured or calculated by Cockcroft-Gault formula) * For female patients who are not sterilised or in menopause (i.e., amenorrhea ≥1 year if age ≥60 years, or ≥2 years if age \<60 years): * negative pregnancy test (urine/serum) * no breast feeding or active pregnancy ambition * reliable contraceptive methods * Signed informed consent Exclusion Criteria: * Distant metastases (e.g., liver, lung, para-aortic lymph nodes; i.e., stations 14 and 16) or small bowel dissemination * Recurrent gastric cancer * Prior resection of the primary gastric tumour * Non-synchronous peritoneal carcinomatosis * Current other malignancy (other than cervix carcinoma and basalioma) * Uncontrolled infectious disease or known infection with Human Immunodeficiency Virus type -1 or -2 * A known history of hepatitis B or C with active viral replication * Recent myocardial infarction (\< 6 months) or unstable angina * Any medical condition not yet specified above that is considered to interfere with study procedures, including adequate follow-up and compliance and/or would jeopardise safe treatment * Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents
Where this trial is running
Amsterdam
- Antoni van Leeuwenhoek/ Netherlands Cancer institute — Amsterdam, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Johanna van Sandick, MD, PHD — Surgeon
- Study coordinator: Judih Quik, MSc
- Email: j.quik@nki.nl
- Phone: 0031 (0) 20 5122954
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stomach Neoplasm, Peritoneal Carcinomatosis, HIPEC, Hyperthermic Intraperitoneal Chemotherapy, gastrectomy, cytoreductive surgery, oxaliplatin, docetaxel