Removing most of the stomach tumor after chemotherapy versus chemotherapy alone for limited metastatic stomach cancer

Cytoreductive Gastrectomy After Systemic Therapy Versus Systemic Therapy Alone For Limited Metastasis Gastric Cancer: An Open-label Randomized Controll Trial

This trial will test whether removing most of the stomach tumor after initial systemic therapy helps people with limited metastatic stomach cancer live longer than systemic therapy alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University Medical Center Ho Chi Minh City (UMC) (Academic / other)
• Drugs / interventions: Trastuzumab, chemotherapy
• Locations: 1 site (Ho Chi Minh City, Ho Chi Minh)
• Trial ID: NCT06768463 on ClinicalTrials.gov

What this trial studies

This trial compares systemic therapy alone to systemic therapy followed by cytoreductive gastrectomy in patients with limited intra‑abdominal metastatic gastric cancer. Eligible adults (18–75) with limited metastases such as liver lesions (maximum diameter ≤5 cm), localized peritoneal carcinomatosis (P1/P2), or defined para‑aortic lymph node involvement and good performance status will be enrolled at University Medical Center Ho Chi Minh City. Participants will receive initial systemic therapy and then be followed for survival and clinical outcomes with or without subsequent gastrectomy. The trial is motivated by mixed prior results, including the REGATTA randomized trial which did not show a clear survival benefit for gastrectomy plus chemotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults 18–75 with limited intra‑abdominal metastases (for example liver lesions ≤5 cm, P1/P2 peritoneal disease, or specific para‑aortic node involvement), ECOG performance status 0, and adequate organ function.

Not a fit: Patients with widespread multi‑organ metastases, large liver tumors, poor performance status, or significant comorbidities are unlikely to benefit from cytoreductive surgery.

Why it matters

Potential benefit: If successful, the approach could extend survival and improve disease control for selected patients with limited intra‑abdominal metastatic gastric cancer.

How similar studies have performed: The randomized REGATTA trial did not demonstrate a survival benefit for gastrectomy followed by chemotherapy versus chemotherapy alone, although some nonrandomized reports and subgroup analyses have suggested possible benefit in selected patients.

Eligibility criteria

Inclusion criteria General criteria

* Age 18-75
* GCLM detected on surgical exploration and demonstrated by histology or cytology
* Localized peritoneal carcinomatosis (P1 or P2 score), according to the classification of the Japanese Research Society for Gastric Cancer
* Liver metastasis lesions of maximum diameter ≤5 cm
* Para-aortic lymph node metastasis below the coeliac axis or above the inferior mesenteric artery (lymph node 16a1/b2 of maximum diameter≥1cm)
* Bilateral or unilateral Krukenberg tumors were allowed and considered 1 incurable organ site
* The accepted patient has two metastases
* Baseline Eastern Cooperative Oncology Group (ECOG) performance status \< 1
* Basic laboratory tests demonstrating adequate bone marrow function (neutrophil count \> 1500mm3, haemoglobin \> 8g/dL, platelet count \> 100,000/mm3), adequate liver function (bilirubin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) within upper limits of normal), adequate renal function (serum creatinine within the upper limit of normal)
* Expected survival \> 3 months
* Able to tolerate enteral nutrition and adequate mental capacity to give informed consent
* Completed 4 cycles of first-line standard-of systemic therapy
* Repeat diagnostic laparoscopy after first-line treatment prior to randomization demonstrating feasible resection.

Eligibility criteria for resection \& extent of proposed resection

* Staging scans (cross-sectional imaging) demonstrating no extra metastases (lung, bone,...)
* Cross-sectional imaging demonstrating no local progression of PM
* PCI score \<12
* Cytology +ve alone (no gross PM) permissible for enrolment
* Feasible R0 resection (reasonable chance of negative margins on histology)
* Feasible D1, D1+ or D2 lymphadenectomy

Exclusion criteria

* 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 this trial is running

Ho Chi Minh City, Ho Chi Minh

• University Medical Center — Ho Chi Minh City, Ho Chi Minh, Vietnam (Recruiting)

Study contacts

• Study coordinator: Vo D Long, Prof.

Conditions Metastatic Gastric Cancer; Gastric Cancer; Systemic Therapy; Cytoreductive Gastrectomy