Cytoreductive Gastrectomy After Systemic Therapy Versus Systemic Therapy Alone For Limited Metastasis Gastric Cancer
Recruiting now · Not applicable
Conditions studied: Metastatic Gastric Cancer, Gastric Cancer, Systemic Therapy, Cytoreductive Gastrectomy
In brief
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.
Key facts
- Study ID
- NCT06768463
- Run by
- University Medical Center Ho Chi Minh City (UMC)
- People needed
- 250
- Starts
- 2025-08-01
- Expected to finish
- 2027-12-10
- Last updated by the study team
- 2025-08-27
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Any extra-abdominal metastasis at diagnosis or during systemic treatment.
- Past history of malignancy other than gastric cancer diagnosed in the last 5 years except for basal cell carcinoma of skin or preinvasive cancer of cervix
- Patients in the reproductive age who declined to use an adequate means of contraception
- Significant disease or conditions which, in the investigator's opinion, would exclude patient from the study
- Uncontrolled concurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant and lactating females
- Prior surgical treatment for GC involving resection
- Clinical or radiological progression during 1st line systemic treatment
- Patients with radiological progression of LM (determined by RECIST criteria) to be excluded as disease is likely not responding well to 1st line treatment.
- Patients with clinical progression of LM as defined by increasing ascites requiring intervention (ascitic tap/drain, hospital admission etc) or causing significant symptoms to the patient (tense distended abdomen, early satiety, shortness of breath etc).
- Ascites volume as a reflection of disease control is difficult to assess and quantify or a reflection of disease progression. (15)
- Any patient deemed unresectable or requiring extensive resection beyond procedure approved in the study protocol
- PCI > 12
- Extensive bowel / mesentery involvement requiring >2 separate / non-contiguous small or large bowel resections in addition to the gastrectomy
- Involvement of the head of pancreas or bile duct
- PM or nodal disease in the hepatoduodenal ligament
- Involvement of major vascular structures
- Involvement of esophagus precluding a reasonable chance of R0 resection by transhiatal approach Withdrawal Criteria
- Patient decides to withdraw from the study, or
- The investigator concludes that it is in the patient's best interest to discontinue study treatment.
Where it is running
- University Medical Center — Ho Chi Minh City, Ho Chi Minh, Vietnam (enrolling)
Full record on ClinicalTrials.gov
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