Laparoscopic Staging for Locally Advanced Gastric Cancer in Chinese Patients

Peking University

Status

Completed

Conditions

Gastric Cancer

Peritoneal Metastases

Treatments

Procedure: Laparoscopic Staging

Study type

Interventional

Funder types

Other

Identifiers

NCT02172690

KW-LStaging-2014

D141100000414004 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

452 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.