Peri-operative Chemotherapy With ECX or XP in the Treatment of Advanced Gastric Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01558947 |
Recruitment Status
: Unknown
Verified March 2012 by Zhejiang Cancer Hospital.
Recruitment status was: Recruiting
First Posted
: March 20, 2012
Last Update Posted
: March 20, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastric Cancer | Drug: Peri-operative chemotherapy of ECX Drug: Peri-operative chemotherapy of XP | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 2 participants |
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 |
Study Start Date : | January 2011 |
Estimated Primary Completion Date : | December 2012 |
Estimated Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
---|---|
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
|
- the relapse-free survival time/rate [ Time Frame: 3 years ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558947
Contact: xiangdong Cheng, MD | +86 571 88122516 | abdsurg@hotmail.com |
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 |
Principal Investigator: | xiangdong Cheng, MD | Zhejiang Cancer Hospital |
Responsible Party: | Zhejiang Cancer Hospital |
ClinicalTrials.gov Identifier: | NCT01558947 History of Changes |
Other Study ID Numbers: |
PC-AGC-01 |
First Posted: | March 20, 2012 Key Record Dates |
Last Update Posted: | March 20, 2012 |
Last Verified: | March 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 |