Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01880632 : Oxaliplatin Plus Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Adenocarcinoma
PhasePhase 2
AgesMin: 18 Years Max: 75 Years
Eligibility
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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01880632      |      Link to official Clinicaltrials.gov listing
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