Cytoreductive Gastrectomy After Systemic Therapy Versus Systemic Therapy Alone For Limited Metastasis Gastric Cancer

Launched by UNIVERSITY MEDICAL CENTER HO CHI MINH CITY (UMC) · Jan 6, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at two treatment options for patients with metastatic gastric cancer, which means the cancer has spread beyond the stomach. The trial will compare a surgery called cytoreductive gastrectomy (where part of the stomach is removed) after patients receive systemic therapy (a type of treatment that travels through the body, like chemotherapy) to see if it helps patients live longer compared to just receiving systemic therapy alone.

To be eligible for this trial, participants must be between 18 and 75 years old and have specific types of cancer spread, such as localized peritoneal carcinomatosis (a type of cancer spread in the abdomen) or certain liver and lymph node metastases. Patients should have completed four cycles of standard systemic therapy and must be able to tolerate nutrition by mouth. They will go through screening tests to ensure their cancer can still be surgically treated safely. If they qualify, participants can expect to receive either the surgery plus ongoing treatment or the standard treatment alone, and they will be monitored closely throughout the study. It's important for potential participants to know that this trial aims to find out the best approach for treating this challenging condition and may help improve future care for gastric cancer patients.

Gender

ALL

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.