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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
Sponsor:
Collaborators:
Ruijin Hospital
RenJi Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Fudan University
Information provided by (Responsible Party):
Tianshu Liu, Shanghai Zhongshan Hospital

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.

Condition or disease Intervention/treatment Phase
Gastric Adenocarcinoma Drug: XELOX Phase 2

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。

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: XELOX
Clinically diagnosed stage T2-3/N+M0,orT4aN+M0 according to CT/MRI scan, and resectable
Drug: XELOX

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





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  • 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.

Exclusion Criteria:

  • Pregnant or lactating (in case of potentially childbearing woman, pregnancy test is positive)
  • Patients of child-bearing age or the potential to father a child who refuse to use adequate contraception
  • Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
  • History of another malignancy in the last 5 years with the exception of the following:

Any previous palliative, adjuvant or neoadjuvant chemotherapy and/or radiotherapy. Prior treatment for locally advanced or metastatic gastric cancer. Any metastatic disease will render patient ineligible according to AJCC staging manual.

  • Distant metastases (M1) including distant nodal Groups (peripancreatic, para-aortic, portal, retroperitoneal, mesenteric node, by CT/MRI, or PET/CT
  • Treatment within the last 30 days with any investigational drug. Concurrent administration of any other cancer therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
  • Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
  • Poorly controlled diabetes mellitus with fasting blood sugar > 18 mM. Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
  • History of significant neurological or mental disorder, including seizures or dementia, which would interfere compliance and sign of consent inform. any history of hypersensitivity to 5-fluorouracil or platinum and other investigational drug
  • Ileus, chronic inflammatory intestinal disease or extensive resection of the small intestine and other disorders which limit drug reabsorption. This includes gastric dumping syndrome, indications of accelerated passage through the small intestine, indications of reabsorption disorders after intestinal surgery
  • Unstable, persistent cardiac disease despite medicinal treatment, myocardial infarction within 6 months before the start of the trial
  • Organ transplant patient need immunosuppression treatment.
  • Previous surgery on primary tumour; Prior palliative surgery (open and closure, passage operation)
  • Any other type of tumour (e.g. leiomyosarcoma, lymphoma) or a secondary malignancy, excepting basal cell skin carcinoma or basal cell carcinoma in situ of the cervix which have already been successfully treated
  • Symptomatic peripheral neuropathy NCI CTC version> 3.0 grade.
  • Patients under anticoagulant therapy with warfarin or other coumarines are excluded from participation.

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): NCT01880632


Contacts
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Contact: Tianshu Liu, Doctor +861368 1973 996 liu.tianshu@zs-hospital.sh.cn

Locations
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China, Shanghai
Zhongshan Hospital Affiliated to Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Tianshu Liu, doctor       liu.tianshu@zs-hospital.sh.cn   
Sub-Investigator: Yiyi yu, Master         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Ruijin Hospital
RenJi Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Fudan University
Investigators
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Principal Investigator: Tianshu Liu, Doctor Medical oncology Shanghai zhongshan hospital

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Responsible Party: Tianshu Liu, Director of Medical oncology derpartment, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT01880632     History of Changes
Other Study ID Numbers: ML28733
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015
Keywords provided by Tianshu Liu, Shanghai Zhongshan Hospital:
XELOX
perioperative treatment
locally advanced gastric adenocarcinoma
D2 resection
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents