Oxaliplatin Plus Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Adenocarcinoma (Neo-Classic)
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|ClinicalTrials.gov Identifier: NCT01880632|
Recruitment Status : Unknown
Verified December 2015 by Tianshu Liu, Shanghai Zhongshan Hospital.
Recruitment status was: Recruiting
First Posted : June 19, 2013
Last Update Posted : December 18, 2015
- Target population:locally advanced gastric adenocarcinoma (LAGC, cT2~3/N+M0,or cT4aN+M0);no previous chemo or radio therapy.
Primary objective:Response rate of XELOX in the neoadjuvant setting of LAGC.
- 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.
- 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.
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Adenocarcinoma||Drug: XELOX||Phase 2|
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Single Arm, Open-label Trial of Oxaliplatin Plus Capecitabine (XELOX) in the Perioperative Treatment of Locally Advanced Gastric Adenocarcinoma|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||August 2018|
Clinically diagnosed stage T2-3/N+M0,orT4aN+M0 according to CT/MRI scan, and resectable
Patients will be given the perioperative chemotherapy as below once recruited:
Capecitabine ：500 mg tablets（Roche） Oxaliplatin：50mg/10ml（according to daily practice in each center）
Schedule of Oxaliplatin plus capecitabine (XELOX) will be as follow:
Capecitabine 1000 mg/m2 ，orally taken 30 minutes after meal, 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
- the response rate of XELOX in the neoadjuvant setting of LAGC [ Time Frame: 6 months after the last subject participating in ]the response rate evaluation will be based on tumor assessment with follow-up, including chest and upper-abdominal During preoperative treatment period, CT scan will be performed every 6 -8 weeks (2 cycles after)., brain MRI and bone scan (ECT) will be performed if any suspected symptoms occur.
- the progression free survival (PFS) in the perioperative treatment of locally advanced gastric adenocarcinoma (cT2-3/N+M0,or cT4aN+M0) [ Time Frame: 42 months after the last subject participating in ]progression by the evidence of CT/MRI scan at each evaluation at neoadjuvant period or follow-up time after surgery；During preoperative treatment period, CT scan will be performed every 6 -8 weeks (2 cycles after).After syrgery, CT scan will be planned every 6 months, brain MRI and bone scan (ECT) will be performed if any suspected symptoms occur.
- percentage of pathological response [ Time Frame: 10 months after the last subject participating in ]After surgery，the pathological response will be measured by the pathologist for every Operation patient.
- Percentage of grade 3 or 4 adverse events as safety profile of perioperative treatments [ Time Frame: 1 month after the last date of treatment ]Adverse events and clinical laboratory tests will be recorded by CTCAE (version 4.0) during the whole treatment period.
- Overall survival [ Time Frame: 3 years after the last subject participating in ]During the OS follow-up, out-patient clinic and telephone visit will be done every 3 months for the first two years, and every 6 months after two years.
- QOL during the whole period of treatment [ Time Frame: 1 years after the last date of treatment ]These assessment will be evaluated at every evaluation.
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): NCT01880632
|Contact: Tianshu Liu, Doctor||+861368 1973 email@example.com|
|Zhongshan Hospital Affiliated to Fudan University||Recruiting|
|Shanghai, Shanghai, China, 200032|
|Contact: Tianshu Liu, doctor firstname.lastname@example.org|
|Sub-Investigator: Yiyi yu, Master|
|Principal Investigator:||Tianshu Liu, Doctor||Medical oncology Shanghai zhongshan hospital|