Laparoscopic Staging for Locally Advanced Gastric Cancer in Chinese Patients

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02172690
• Other study ID #: KW-LStaging-2014
• Secondary ID: D141100000414004
• Status: Recruiting
• Phase: N/A
• First received: June 20, 2014
• Last updated: December 6, 2014
• Start date: June 2014
• Est. completion date: December 2017

Study information

• Verified date: December 2014
• Source: Peking University
• Contact: Jiafu Ji, MD
• Phone: 0086-10-88196391
• Email: jiafuj[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastric Cancer
• Peritoneal Metastases
• Stomach Neoplasms

Intervention

Procedure:
• Laparoscopic Staging
Laparoscopic Staging

Locations

Country	Name	City	State
China	Peking Unicersity Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peritoneal Metastasis or Positive Cytology		7days	No
Secondary	Safety	Number of Participants with Adverse Events(III or IV grades according to NCI-CTC)	30days	Yes