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Laparoscopic Staging for Locally Advanced Gastric Cancer in Chinese Patients

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ClinicalTrials.gov Identifier: NCT02172690
Recruitment Status : Unknown
Verified December 2014 by Jiafu Ji, Peking University.
Recruitment status was:  Recruiting
First Posted : June 24, 2014
Last Update Posted : December 9, 2014
Sponsor:
Information provided by (Responsible Party):
Jiafu Ji, Peking University

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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




Primary Outcome Measures :
  1. Peritoneal Metastasis or Positive Cytology [ Time Frame: 7days ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: 30days ]
    Number of Participants with Adverse Events(III or IV grades according to NCI-CTC)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02172690


Contacts
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Contact: Jiafu Ji, MD 0086-10-88196391 jiafuj@hotmail.com

Locations
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China, Beijing
Peking Unicersity Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Jiafu Ji, MD    86-10-88196391    jiafuj@hotmail.com   
Principal Investigator: Jiafu Ji, MD         
Sponsors and Collaborators
Peking University
Investigators
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Principal Investigator: Jiafu Ji, MD Peking University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jiafu Ji, Professor, Peking University
ClinicalTrials.gov Identifier: NCT02172690    
Other Study ID Numbers: KW-LStaging-2014
D141100000414004 ( Other Grant/Funding Number: Beijing Municipal Science & Technology Commission )
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014
Keywords provided by Jiafu Ji, Peking University:
Gastric Cancer
Laparoscopic Staging
Cytology
Peritoneal Metastases
Additional relevant MeSH terms:
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Neoplasm Metastasis
Stomach Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases