Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT01880632
Brief Summary:
1. Target population:locally advanced gastric adenocarcinoma (LAGC, cT2\~3/N+M0,or cT4aN+M0);no previous chemo or radio therapy.
2. Primary objective:Response rate of XELOX in the neoadjuvant setting of LAGC.
Secondary objectives:
* The progression free survival (PFS) in the perioperative treatment of locally advanced gastric adenocarcinoma (cT3/N+M0,or cT4aN+M0);
* percentage of pathological response ; percentage of grade 3 or 4 adverse events as safety profile of perioperative treatments;
* D2 resection -rate after neoadjuvant chemotherapy of XELOX;
* Overall survival;
* QOL during the whole period of treatment.
3. Trial design:This is a multicenter, single arm, open-label, phase II study to evaluate the efficacy and safety of Oxaliplatin plus capecitabine(XELOX) in the perioperative treatment of locally advanced gastric adenocarcinoma in combination with D2 resection.
4. Treatment plan:Patients will be given the perioperative chemotherapy as below once recruited:Schedule of Oxaliplatin plus capecitabine (XELOX) will be as follow: Capecitabine 1000 mg/m2 ，bid,d 1\~14 every 3 weeks(treatment for 2 weeks and rest 1 week)Oxaliplatin：130mg/m2， iv infusion over 2h，d1,every 3 weeks.
5. Number of subjects:50 patients.Number of centers 5 sites, which have the high volume of gastric operations in China, more than 500 per year.
Detailed Description:
1. Disease specific inclusion criteria:
* Histologically documented gastricadenocarcinoma with Lauren classification Clinically diagnosed stage T2-3/N+M0,orT4aN+M0 according to CT/MRI scan, and resectable
* Measurable disease is required
* Karnofsky score 80%.
* Physical condition and adequate organ function to ensure the success of abdominal surgery.
* Life expectancy ≥12 weeks.
* Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥8g/dL .Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) \< 2.5 × ULN in the absence of liver metastases, or \< 5 × ULN in case of liver metastases. ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L.
Adequate renal function: Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60 ml/min.
* Female subjects should not be pregnant or breast-feeding.
* No serious concomitant disease that will threaten the survival of patients to less than 5 years.
2. General inclusion criteria:
* Male or female. Age ≥ 18 years and ≤75 years
* Written (signed) informed consent.
* Able to comply with study and follow-up procedures.
* Good compliance with the treatment plan。
* Consent to provide tissue sample。
Study:
NCT01880632
Study Brief:
Protocol Section:
NCT01880632