Surgery and chemotherapy for gastric cancer with peritoneal spread
Complete Cytoreductive Surgery With Combined Intraperitoneal and Systemic Chemotherapies for Gastric Adenocarcinoma Patients With Limited Peritoneal Carcinomatosis: an Open-label Two-stage Phase II Trial
This study is testing if a combination of surgery and specific chemotherapy can help people with advanced stomach cancer that has spread to the lining of the abdomen feel better and control their disease for at least six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Taipei) |
| Trial ID | NCT04547725 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of complete cytoreductive surgery (CRS) followed by normothermic intraperitoneal chemotherapy (N-IPEC) and systemic chemotherapy in patients with gastric adenocarcinoma that has limited peritoneal carcinomatosis. The study aims to determine the 6-month disease control rate in patients who meet specific criteria, including those with a peritoneal carcinomatosis index (PCI) of 10 or less or positive peritoneal wash cytology. Participants will undergo surgery and receive chemotherapy regimens that include paclitaxel, high-dose fluorouracil, and cisplatin or capecitabine and oxaliplatin. The trial seeks to improve treatment outcomes for patients who currently have limited options due to the aggressive nature of their disease.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 75 with newly diagnosed gastric adenocarcinoma and limited peritoneal carcinomatosis.
Not a fit: Patients with distant metastasis or those who have received prior treatment for gastric adenocarcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve disease control and survival rates for patients with gastric cancer and peritoneal carcinomatosis.
How similar studies have performed: Previous studies have shown promising results with similar approaches, particularly with normothermic intraperitoneal chemotherapy.
Eligibility criteria
Show full inclusion / exclusion criteria
\[Inclusion criteria\] 1. Age 20 to 75 years old. 2. Blood tests: 1. White blood cells \> 4,000/mm3, neutrophils \> 1,500/mm3, platelets \> 100,000/mm3. 2. Serum creatinine \< 1.5 mg/dl or creatinine clearance \> 60 ml/min. 3. Serum bilirubin \< 2 mg/dl. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status = 0 or 1. 4. Not legal incapacity. 5. Newly diagnosed gastric adenocarcinoma, including Siewert III adenocarcinoma of the cardia, with limited peritoneal carcinomatosis (PCI ≤ 10) or positive peritoneal wash cytology (CY1/P0) . \[Exclusion criteria\] 1. Prior malignancy within 3 years or with detectable signs of recurrence. 2. Newly diagnosed gastric adenocarcinoma having been treated by preoperative systemic or intraperitoneal chemotherapy. 3. Presence of comorbidities, including liver cirrhosis (≥ Child B), decompensated heart failure (New York Heart Association \[NYHA\] Class III or IV congestive heart failure), poorly-controlled chronic obstructive pulmonary disease. 4. ≥ American Society of Anesthesiologists Classification (ASA Class) Class 3. 5. Pregnancy or breastfeeding. 6. Intolerability of chemotherapeutic agents in this study: 1. N-IPEC paclitaxel (all patients). 2. Capecitabine or oxaliplatin (patients who receive CAPOX regimen). 3. Cisplatin or 5-fluorouracil (patients who receive P-HDFL regimen). 7. Distant metastases (e.g. liver, lung, bone) except for the peritoneum, intra-abdominal lymph node, and ovary. 8. Extensive PC (PCI \> 10). 9. Siewert I or II adenocarcinoma of the cardia. 10. Other patients inappropriate for this study in the opinion of the investigators.
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: I-Rue Lai, MDPHD — National Taiwan University Hospital
- Study coordinator: Hung-Hsuan Yen, MD
- Email: yhhdean@gmail.com
- Phone: 0910012718
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.