Laparoscopic Staging for Locally Advanced Gastric Cancer in Chinese Patients

Sponsor

Peking University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02172690

Collaborator

(none)

450

Enrollment

Location

Arm

Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer Peritoneal Metastases	Procedure: Laparoscopic Staging	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Jun 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Laparoscopic Staging For Patients diagnosed as Locally Advanced Gastric Cancer(cT2+NanyM0)by CT and EUS, undergo laparoscopic staging.	Procedure: Laparoscopic Staging Laparoscopic Staging

Arm

Intervention/Treatment

Experimental: Laparoscopic Staging

For Patients diagnosed as Locally Advanced Gastric Cancer(cT2+NanyM0)by CT and EUS, undergo laparoscopic staging.

Procedure: Laparoscopic Staging

Laparoscopic Staging

Outcome Measures

Primary Outcome Measures

Peritoneal Metastasis or Positive Cytology [7days]

Secondary Outcome Measures

Safety [30days]
Number of Participants with Adverse Events(III or IV grades according to NCI-CTC)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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 ≥ 1.5109/l Hemoglobin ≥ 9 g/dl Platelets ≥ 100109/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.