Actively Recruiting
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
Led by National Taiwan University Hospital · Updated on 2024-04-16
48
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the 6-month disease control rate in patients with gastric adenocarcinoma who have limited peritoneal carcinomatosis or positive peritoneal wash cytology. Peritoneal carcinomatosis in these patients is usually considered an advanced and difficult-to-treat condition, and current palliative chemotherapy options have limited effectiveness. The study focuses on a combined treatment approach involving surgery and chemotherapy to improve outcomes for these patients. Participants will receive complete cytoreductive surgery followed by normothermic intraperitoneal chemotherapy with paclitaxel combined with systemic chemotherapy regimens, either high-dose fluorouracil and cisplatin (P-HDFL) or capecitabine and oxaliplatin (CAPOX). Treatment cycles involve multiple administrations of these therapies on specified days within each cycle. Patients may receive up to 6 or 8 cycles of this combined treatment depending on the chemotherapy regimen, followed by continued systemic chemotherapy alone until disease progression or death. The study is conducted in two stages with predefined patient numbers in each arm based on disease characteristics. During the study, patients will undergo regular monitoring including computed tomography scans every 12 weeks to assess disease status and ascites response. Clinical evaluations will occur every 2 to 3 weeks depending on the chemotherapy used. Peritoneal cytology samples will be collected at surgery and at the start of each treatment cycle. The study also tracks progression-free survival, overall survival, and safety outcomes over periods up to 3 years. Participation may last several months to years depending on treatment response and disease progression.
CONDITIONS
Brief 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 3 years or signs of recurrence
- Previous preoperative systemic or intraperitoneal chemotherapy for gastric adenocarcinoma
- Comorbidities such as liver cirrhosis (≥ Child B), decompensated heart failure (NYHA Class III or IV), or poorly controlled chronic obstructive pulmonary disease
- American Society of Anesthesiologists Classification (ASA) Class 3 or higher
- Pregnancy or breastfeeding
- Intolerance to study chemotherapeutic agents: N-IPEC paclitaxel, capecitabine or oxaliplatin (for CAPOX regimen), cisplatin or 5-fluorouracil (for P-HDFL regimen)
- Presence of distant metastases except peritoneum, intra-abdominal lymph nodes, or ovary
- Extensive peritoneal carcinomatosis (PCI > 10)
- Siewert I or II adenocarcinoma of the cardia
- Other conditions deemed inappropriate by investigators
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay for surgery and recovery (duration varies per participant)
Participants undergo complete cytoreductive surgery (CRS) including D2 or more extensive gastrectomy, followed by immediate post-operative care.
1 surgery visit and immediate post-operative care
Duration - Up to 6 cycles for P-HDFL or 8 cycles for CAPOX, followed by continued systemic chemotherapy until disease progression or death
Participants receive normothermic intraperitoneal chemotherapy (N-IPEC) combined with systemic chemotherapy (P-HDFL or CAPOX). N-IPEC with paclitaxel is administered on specified days per cycle, with up to 6 cycles for P-HDFL or 8 cycles for CAPOX. Systemic chemotherapy continues until disease progression or death.
Outpatient visits every 2 weeks for P-HDFL or every 3 weeks for CAPOX during treatment
Duration - Up to 3 years post-treatment
Participants are monitored for disease status, ascites amount, and safety through clinical evaluations and imaging every 12 weeks after treatment ends.
Clinical evaluations every 12 weeks
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
Research Team
H
Hung-Hsuan Yen, MD
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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