Actively Recruiting
Cytoreductive Gastrectomy After Systemic Therapy Versus Systemic Therapy Alone For Limited Metastasis Gastric Cancer
Led by University Medical Center Ho Chi Minh City (UMC) · Updated on 2025-08-27
250
Participants Needed
1
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The results of the current studies to determine the optimal strategy for metastatic gastric cancer remain contrversial worldwide. Hypothesis: Cytoreductive Gastrectomy After Systemic Therapy will improve survival time for metastasis gastric cancer compared to Systemic Therapy alone.
CONDITIONS
Official Title
Cytoreductive Gastrectomy After Systemic Therapy Versus Systemic Therapy Alone For Limited Metastasis Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Metastatic gastric cancer with limited metastases detected by surgery and confirmed by histology or cytology
- Localized peritoneal carcinomatosis (P1 or P2 score)
- Liver metastases with maximum diameter 5 cm or less
- Para-aortic lymph node metastasis below the coeliac axis or above the inferior mesenteric artery with maximum diameter 1 cm or less
- Presence of one or two metastases including bilateral or unilateral Krukenberg tumors
- ECOG performance status less than 1
- Adequate bone marrow function (neutrophil count >1500/mm3, hemoglobin >8 g/dL, platelet count >100,000/mm3)
- Adequate liver function (bilirubin, AST, ALT within normal limits)
- Adequate kidney function (serum creatinine within normal limits)
- Expected survival longer than 3 months
- Ability to tolerate enteral nutrition and provide informed consent
- Completion of 4 cycles of first-line standard systemic therapy
- Feasible resection confirmed by repeat diagnostic laparoscopy after first-line treatment
- No extra-abdominal metastases on imaging
- No local progression of peritoneal metastases
- Peritoneal Cancer Index (PCI) score less than 12
- Cytology positive without gross peritoneal metastases allowed
- Feasible R0 resection with possible D1, D1+, or D2 lymphadenectomy
You will not qualify if you...
- Presence of any metastases outside the abdomen at diagnosis or during treatment
- History of other malignancies in the past 5 years except basal cell carcinoma of the skin or preinvasive cervical cancer
- Patients of reproductive age who do not use adequate contraception
- Significant diseases or conditions that would exclude the patient as judged by the investigator
- Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, or arrhythmia
- Psychiatric or social conditions limiting study compliance
- Pregnant or breastfeeding women
- Previous surgical treatment for gastric cancer involving resection
- Clinical or radiological progression during first-line systemic therapy
- Patients with radiological progression of liver metastases
- Patients with clinical progression causing significant symptoms or requiring intervention for ascites
- Patients deemed unresectable or requiring extensive surgery beyond the approved protocol
- Peritoneal Cancer Index (PCI) greater than 12
- Extensive bowel or mesentery involvement requiring multiple bowel resections beyond gastrectomy
- Involvement of pancreas head, bile duct, hepatoduodenal ligament, major blood vessels, or esophagus precluding complete tumor removal
- Patient withdrawal or investigator’s decision to stop study treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Medical Center
Ho Chi Minh City, Ho Chi Minh, Vietnam, 700000
Actively Recruiting
Research Team
V
Vo D Long, Prof.
CONTACT
N
Nguyen V Hai, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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