Surgery and chemotherapy for gastric cancer with peritoneal spread

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

\[Inclusion criteria\]

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.