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โ† Trials
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Complete Cytoreduction Followed by IP and Systemic Chemotherapies for Gastric Cancer With Peritoneal Carcinomatosis

RecruitingNAAges 20 Years - 75 YearsAllNational Taiwan University Hospital
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In plain words

What the trial is, and whether it could suit you

Background: Approximately 15% of gastric adenocarcinoma patients presents with peritoneal carcinomatosis (PC) at the first encounter and is regarded as an unresectable and end-stage disease. The recommended treatment with palliative chemotherapy alone yields a poor clinical efficacy. Emerging evidences suggest the survival benefits of complete cytoreductive surgery (CRS) combined with normothermic intraperitoneal chemotherapy (N-IPEC) for gastric adenocarcinoma with limited PC. Objective: To evaluate the 6-month disease control rate (DCR) of complete CRS combined with N-IPEC and systemic chemotherapy for gastric adenocarcinoma with limited PC. Patients and methods: Patients having gastric adenocarcinoma with PCI โ‰ค 10 (Arm-A) or positive peritoneal wash cytology (CY1/P0) (Arm-B) will be enrolled. Patients with other distant metastasis, including brain, lung, liver, bone, will be exclude

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
\[Inclusion criteria\] 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 โ‰ค 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 (โ‰ฅ Child B), decompensated heart failure (New York Heart Association \[NYHA\] Class III or IV congestive heart failure), poorly-controlled chronic obstructive pulmonary disease. 4. โ‰ฅ 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.
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What it tests

  • CRS followed by IP and systemic chemotherapies
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Where

1 site
National Taiwan University Hospital
Taipei, Taiwan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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