Laparoscopic Staging for Locally Advanced Gastric Cancer in Chinese Patients (NCT02172690) | Clinical Trial Compass
CompletedNot Applicable
Laparoscopic Staging for Locally Advanced Gastric Cancer in Chinese Patients
China452 participantsStarted 2014-01-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 sampleï¼›
* With distant metastasis diagnosed by CT/EUSï¼›
* 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)ï¼›
* Patients with central nervous system(CNS) disorder or peripheral nervous system disorder or psychiatric diseaseï¼›
* Concurrent severe infectionï¼›
* Concur…