Actively Recruiting
Complete Cytoreduction Followed by IP and Systemic Chemotherapies for Gastric Cancer With Peritoneal Carcinomatosis
Led by National Taiwan University Hospital · Updated on 2024-04-16
48
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 ≤ 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 excluded. All patients should undergo ≥ D2 gastrectomy and complete CRS followed by N-IPEC (paclitaxel\] and systemic chemotherapy (high-dose fluorouracil and cisplatin \[P-HDFL\], or capecitabine and oxaliplatin \[CAPOX\]). N-IPEC (paclitaxel) will be administered in combination with systemic P-HDFL or CAPOX on day 1,8,15 or day 1,8 for each cycle, respectively. The disease status will be evaluated every 12 weeks based on the computed tomography scan, and the clinical evaluation (outpatient follow-up) will be performed every 2 weeks for whom receiving P-HDFL and every 3 weeks for whom receiving CAPOX. Patients will receive maximal 6 cycles N-IPEC with P-HDFL or 8 cycles N-IPEC with CAPOX. After N-IPEC is discontinued, P-HDFL or CAPOX will be continued alone until disease progression or death. The primary endpoint of this study is 6-month DCR, and the secondary endpoints include 6-month response rate for ascites, 1-year progression-free survival (PFS) and overall survival (OS), 3-year PFS and OS, and safety profiles. Based on Simon's minimax two-stage design, this trial will be carried out in two stages. In stage I, a total number of 13 (Arm-A) / 16 (Arm-B) patients is accrued. If there are ≤ 6 (Arm-A) / ≤ 14 (Arm-B) progression-free among these 13 (Arm-A) / 16 (Arm-B) patients, the study will be early stopped. Otherwise, additional 17 (Arm-A) / 2 (Arm-B) patients will be accrued in stage II, resulting in a total number sample size of 30 (Arm-A) / 18 (Arm-B). Expected result: A ≥ 75% (Arm-A) / ≥ 95% (Arm-B) 6-month DCR could be achieved for gastric adenocarcinoma patients with limited PC (Arm-A) / with CY1P0 (Arm-B) via this treatment strategy (complete CRS + N-IPEC + P-HDFL or CAPOX) -i.e., if there are ≥ 21 (Arm-A) / ≥ 16 (Arm-B) progression-free among the 30 (Arm-A) / 18 (Arm-B) enrolled patients, we will reject the null hypothesis and claim that the treatment is promising.
CONDITIONS
Official Title
Complete Cytoreduction Followed by IP and Systemic Chemotherapies for Gastric Cancer With Peritoneal Carcinomatosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 to 75 years old.
- White blood cells > 4,000/mm3, neutrophils > 1,500/mm3, platelets > 100,000/mm3.
- Serum creatinine < 1.5 mg/dl or creatinine clearance > 60 ml/min.
- Serum bilirubin < 2 mg/dl.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Not legally incapacitated.
- Newly diagnosed gastric adenocarcinoma, including Siewert III adenocarcinoma of the cardia, with limited peritoneal carcinomatosis (PCI ≤ 10) or positive peritoneal wash cytology (CY1/P0).
You will not qualify if you...
- Prior malignancy within the past 3 years or signs of recurrence.
- Previous treatment of newly diagnosed gastric adenocarcinoma with preoperative systemic or intraperitoneal chemotherapy.
- Presence of severe comorbidities including liver cirrhosis (Child B or greater), decompensated heart failure (NYHA Class III or IV), or poorly-controlled chronic obstructive pulmonary disease.
- American Society of Anesthesiologists (ASA) Classification of 3 or higher.
- Pregnancy or breastfeeding.
- Intolerance to study chemotherapeutic agents: paclitaxel for all, capecitabine or oxaliplatin for CAPOX regimen, cisplatin or 5-fluorouracil for P-HDFL regimen.
- Presence of distant metastases outside the peritoneum such as liver, lung, or bone.
- Extensive peritoneal carcinomatosis (PCI > 10).
- Siewert I or II adenocarcinoma of the cardia.
- Other conditions deemed unsuitable by investigators.
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Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
Research Team
H
Hung-Hsuan Yen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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