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A Multicenter, Single Arm, Open-label Trial of Oxaliplatin Plus Capecitabine (XELOX) in the Perioperative Treatment of Locally Advanced Gastric Adenocarcinoma


Phase 2/Phase 3
18 Years
75 Years
Not Enrolling
Both
Gastric Adenocarcinoma

Thank you

Trial Information

A Multicenter, Single Arm, Open-label Trial of Oxaliplatin Plus Capecitabine (XELOX) in the Perioperative Treatment of Locally Advanced Gastric Adenocarcinoma


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。


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

the response rate of XELOX in the neoadjuvant setting of LAGC

Outcome Description:

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.

Outcome Time Frame:

6 months after the last subject participating in

Safety Issue:

No

Principal Investigator

Tianshu Liu, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical oncology Shanghai zhongshan hospital

Authority:

United States: Food and Drug Administration

Study ID:

ML28733

NCT ID:

NCT01880632

Start Date:

July 2013

Completion Date:

August 2018

Related Keywords:

  • Gastric Adenocarcinoma
  • XELOX
  • perioperative treatment
  • locally advanced gastric adenocarcinoma
  • D2 resection
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms

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