Laparoscopic Staging for Locally Advanced Gastric Cancer in Chinese Patients

NCT02172690 | Completed DMC

• 2 other identifiers: KW-LStaging-2014D141100000414004
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer; Peritoneal Metastases

Keywords

Gastric Cancer; Laparoscopic Staging; Cytology; Peritoneal Metastases

Outcome Measures

Primary Outcomes (1)

• Peritoneal Metastasis or Positive Cytology

  7days

Secondary Outcomes (1)

• Number of Participants with Adverse Events

  30days

Study Arms (1)

Laparoscopic Staging

EXPERIMENTAL

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

Procedure: Laparoscopic Staging

Interventions

Laparoscopic Staging PROCEDURE

Laparoscopic Staging

Laparoscopic Staging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking Unicersity Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Related Publications (1)

• Li Z, Li Z, Zhang L, Liu Q, Wang Z, Zhang Z, Xiao G, Fu W, Wang X, Ye Y, Yu J, Li F, Chen L, Wang S, Ji J. Staging laparoscopy for locally advanced gastric cancer in Chinese patients: a multicenter prospective registry study. BMC Cancer. 2018 Jan 10;18(1):63. doi: 10.1186/s12885-017-3791-6.

  PMID: 29321007 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Jiafu Ji, MD

  Peking University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 24, 2014
• Study Start: January 1, 2014
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

CN (1)