Peri-operative Chemotherapy With ECX or XP in the Treatment of Advanced Gastric Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Zhejiang Cancer Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01558947
First received: March 7, 2012
Last updated: March 18, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Gastric Cancer
Drug: Peri-operative chemotherapy of ECX
Drug: Peri-operative chemotherapy of XP
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Zhejiang Cancer Hospital:

Primary Outcome Measures:
  • the relapse-free survival time/rate [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2
Study Start Date: January 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chemotherapy with ECX
chemotherapy with ECX
Drug: Peri-operative chemotherapy of ECX
Preoperative chemotherapy of ECX for 3 cycles(Epirubicin 50mg/m2 on day 1; capecitabine 1000mg/m2, 2 times / day, 1 to 14 days; cisplatin 60mg/m2 on day 1, need hydration, 21 day/cycle), operation after 2~4 weeks, and postoperative chemotherapy of ECX for 3 cycles 4~6 weeks after surgery.
Other Name: ECX chemotherapy
Experimental: chemotherapy with XP
chemotherapy with XP
Drug: Peri-operative chemotherapy of XP
Preoperative chemotherapy of XP for 3 cycles(capecitabine 1000mg/m2, 2 times / day, 1 to 14 days; cisplatin 60mg/m2 on day 1, need hydration, 21 day/cycle), operation after 2~4 weeks, and postoperative chemotherapy of XP for 3 cycles 4~6 weeks after surgery.
Other Name: XP chemotherapy

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558947

Contacts
Contact: xiangdong Cheng, MD +86 571 88122516 abdsurg@hotmail.com

Locations
China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: xiangdong Cheng, MD    +86 571 88122516    abdsurg@hotmail.com   
Principal Investigator: xiangdong Cheng, MD         
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
Principal Investigator: xiangdong Cheng, MD Zhejiang Cancer Hospital
  More Information

No publications provided

Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT01558947     History of Changes
Other Study ID Numbers: PC-AGC-01
Study First Received: March 7, 2012
Last Updated: March 18, 2012
Health Authority: China: Food and Drug Administration
United States: Food and Drug Administration

Keywords provided by Zhejiang Cancer Hospital:
gastric cancer
Peri-operative chemotherapy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014