Clinical trial NCT01558947: Peri-operative Chemotherapy With ECX or XP in the Treatment of Advanced Gastric Cancer
Official title: Peri-operative Chemotherapy With ECX (Epirubicin + Cisplatin + Capecitabine) or XP (Capecitabine + Cisplatin) in the Treatment of Advanced Gastric Cancer: a Randomized, Multicenter, Parallel Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: gastric cancer
Peri-operative chemotherapy
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2012-03-20
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and the effect of perioperative chemotherapy in the treatment of advanced gastric cancer.

Detailed description: 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

Eligibility criteria: 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.

Primary outcomes:
measure: the relapse-free survival time/rate
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: xiangdong Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References: