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Peri-operative Chemotherapy With ECX or XP in the Treatment of Advanced Gastric Cancer
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Zhejiang Cancer Hospital.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Zhejiang Cancer Hospital
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
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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 Intervention Model: Parallel Assignment Masking: Single (Participant) 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 ]
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01558947
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
| 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 |
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 Cisplatin Capecitabine |
Epirubicin Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on August 23, 2017