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

NCT06768463 | Recruiting DMC

• 1 other identifier: CYGAS-GC
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (2)

• Median survival time

  the median length of time from the date of randomization to death from any cause or to the last follow-up for a surviving patient the median length of time from the date of randomization to death from any cause or to the last follow-up for a surviving patient

  36 months after surgery

• Progression-free survival (PFS)

  Time interval from randomization to either radiological/clinical recurrence (Arm 1) or progression (Arm 2) or death from any cause. Patients who remained alive and without recurrence at the time of analysis or who are lost to follow-up will be censored at the date last seen

  3 year after surgery

Secondary Outcomes (8)

• Overall survival (OS

  3 year after surgery

• Cytoreductive completenes of peritonectomy (for Arm 1)

  within 30 days after surgery

• R0 resection rate (for Arm 1)

  3-month after conversion surgery

• Early complication rate (Arm 1)

  30-day postoperative

• Late comlication rate (Arm 1)

  3 year after surgery

Study Arms (2)

Cytoreductive Gastrectomy After Systemic Therapy

EXPERIMENTAL

After 4 cycles of systemic therapy, the patients with complete response, or partial response, or stable disease undergo gastretomy. After gastrectomy, the patients continue to use systemic therapy.

Procedure: Cytoreductive Gastrectomy

Systemic Therapy Alone

NO INTERVENTION

The patients only use systemic therapy.

Interventions

Cytoreductive Gastrectomy PROCEDURE

The patients undergo gastrectomy after 4 cycles of systemic therapy

Cytoreductive Gastrectomy After Systemic Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,...)

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

Sponsors & Collaborators

• University Medical Center Ho Chi Minh City (UMC): lead

Study Sites (1)

University Medical Center

Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Vo D Long, Prof.

CONTACT

+84918133915; long.vd@umc.edu.vn

Nguyen V Hai, MD

CONTACT

hai.nv@umc.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cytoreductive Gastrectomy After Systemic Therapy For Limited Metastasis Gastric Cancer

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 10, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 10, 2027
• Study Completion (Estimated): December 10, 2027
• Last Updated: August 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)