Laparoscopic Staging for Locally Advanced Gastric Cancer in Chinese Patients

Study Overview
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Brief Summary
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RATIONALE: Laparoscopic staging may help doctors plan more effective treatment for gastric cancer, yet the efficiency have not been fully investigated in Chinese people. PURPOSE: Study the effectiveness of laparoscopic staging in patients with pre-diagnosed as locally advanced gastric cancer.

Detailed Description
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OBJECTIVES: I. Determine the feasibility of laparoscopic staging of patients with pre-diagnosed as locally advanced gastric cancer. II. Assess the adverse effects associated with this technique. OUTLINE: Surgery. Laparoscopy with cytologic examination. PROJECTED ACCRUAL: Up to 450 patients will be accrued over approximately 2 years.

Official Title
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Laparoscopic Staging in Patients With Locally Advanced Gastric Cancer in Chinese Patients

Conditions
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Gastric Cancer, Peritoneal Metastases

Intervention / Treatment
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* Procedure: Laparoscopic Staging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: sign written informed consent form age ≥ 18 years pathologically confirmed gastric or GEJ adenocarcinoma disease at clinical stage of locally advanced gastric cancer by CT/EUS(cT2+NanyM0) No prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy Adequate organ function as defined below: Hematologic ANC ≥ 1.5*109/l Hemoglobin ≥ 9 g/dl Platelets ≥ 100*109/l Hepatic Albumin ≥ 30g/l Serum bilirubin ≤ 1.5×ULN AST and ALT ≤ 2.5×ULN ALP ≤ 2.5×ULN TBIL ≤ 1.5×ULN Renal Serum Creatinine < 1.5 ULN KPS ≥ 70 Adequate lung and heart function Negative serum or urine pregnant test within 7 days prior to randomization for child-bearing age women Sexually active males or females willing to practice contraception during the study until 30 days after end of study. Exclusion Criteria: Refuse to provide blood/tissue sample； With distant metastasis diagnosed by CT/EUS； Sexually active males or females refuse to practice contraception during the study until 30 days after end of study. History of organ transplantation（including autologous bone marrow transplantation and Peripheral stem cell transplantation）； Prior long term steroid therapy (excluding short term steroid treatment which is completed prior to > 2 weeks of study enrollment)； Patients with central nervous system(CNS) disorder or peripheral nervous system disorder or psychiatric disease； Concurrent severe infection； Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety (including current active hepatic, biliary, renal, respiratory disease, uncontrolled diabetes hypertension et al)； History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible； Known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and hypertension, or congestive heart failure, or cardiac infarction within 6 months prior to study enrollment, or cardiac insufficiency； Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic Staging<br>For Patients diagnosed as Locally Advanced Gastric Cancer(cT2+NanyM0)by CT and EUS, undergo laparoscopic staging. | Procedure: Laparoscopic Staging<br>* Laparoscopic Staging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peritoneal Metastasis or Positive Cytology |  | 7days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Number of Participants with Adverse Events(III or IV grades according to NCI-CTC) | 30days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cytology, Peritoneal Metastases, Gastric Cancer, Laparoscopic Staging