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Peri-operative Chemotherapy With ECX (Epirubicin + Cisplatin + Capecitabine) or XP (Capecitabine + Cisplatin) in the Treatment of Advanced Gastric Cancer: a Randomized, Multicenter, Parallel Control


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Gastric Cancer

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Trial Information

Peri-operative Chemotherapy With ECX (Epirubicin + Cisplatin + Capecitabine) or XP (Capecitabine + Cisplatin) in the Treatment of Advanced Gastric Cancer: a Randomized, Multicenter, Parallel Control


To evaluate the security and the relapse-free survival time/rate(1,2,3 yrs) of perioperative
chemotherapy with ECX (epirubicin + cisplatin + capecitabine) and XP (capecitabine +
cisplatin)in advanced gastric cancer


Inclusion Criteria:



- Male and female aged 18 to 70 years old.

- The preoperative evaluation: gastric cancer patients, ≥ T2 or N +; or staging II,
IIIA, IIIB.

- Karnofsky score ≥ 70, life expectancy > 6 months.

- Endoscopic biopsy diagnosis of gastric cancer, excluding non-Hodgkin's lymphoma,
leiomyosarcoma and other mesenchymal tumors.

- the blood and biochemical indicators of the subjects must meet the following
criteria: Hb ≥ 9 g / dl; WBC ≥ 4,000 / mm3, ≤ 12000 / mm3; PLT ≥ 100,000/mm3; GOT,
GPT within twice the institutional limit,serum total bilirubin < 1.5 times the upper
limit of normal, serum creatinine< 1.25 times the upper limit of normal and
creatinine clearance rate ≥ 60ml/min, LVEF ≥ 60%.

- have not received prior chemotherapy, radiotherapy and biological therapy.

- signed informed consent.

- must accept the standard D2 or D2 + radical gastrectomy.

- with good compliance.

Exclusion Criteria:

- pregnancy, breast-feeding women.

- allergy with chemotherapy drugs or metabolic disorder.

- the history of organ transplants (including bone marrow transplantation and
autologous peripheral stem cell transplantation).

- had long received systemic steroid treatment (Note: short-term users of withdrawal >
2 weeks can be selected.)

- The existence of the peripheral nervous system disorders or significant neurological
disorders and a history of central nervous system disorders.

- patients with severe infection requires treatment.

- patients associated with dysphagia, active peptic ulcer, incompleteness intestinal
obstruction, active gastrointestinal bleeding, perforation.

- severe liver disease (such as cirrhosis), kidney disease, respiratory disease or
uncontrollable diabetes.

- with other malignancies which were not cured.

- EKG abnormalities or heart disease with apparent clinical symptoms, including
congestive heart failure, coronary heart disease with symptoms, uncontrollable
arrhythmia, hypertension, and heart attack within 12 months or III or IV grade
myocardial infarction. Coronary heart disease with symptoms, uncontrollable
arrhythmia, hypertension, and heart attack within 12 months or III or IV grade
myocardial infarction.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

the relapse-free survival time/rate

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

xiangdong Cheng, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zhejiang Cancer Hospital

Authority:

China: Food and Drug Administration

Study ID:

PC-AGC-01

NCT ID:

NCT01558947

Start Date:

January 2011

Completion Date:

June 2013

Related Keywords:

  • Gastric Cancer
  • gastric cancer
  • Peri-operative chemotherapy
  • Stomach Neoplasms

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