Observational Study of Perioperative Chemotherapy in Gastric Cancer (PRECISO)
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First Received Date ICMJE | June 30, 2012 | ||||||||
Last Updated Date | June 30, 2012 | ||||||||
Start Date ICMJE | August 2010 | ||||||||
Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
rate of downstaging [ Time Frame: 3 months ] [ Designated as safety issue: No ] To determine the rate of downstaging of locally advanced cT3-4 and/or N+ gastric carcinomas after 3 cycles of preoperative chemotherapy with ECX |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Observational Study of Perioperative Chemotherapy in Gastric Cancer | ||||||||
Official Title ICMJE | Prospective Observational Study of Patients With Locally Advanced Gastric Cancer Treated With Perioperative Chemotherapy and Surgery | ||||||||
Brief Summary | This study will assess the efficacy and toxicity of perioperative chemotherapy with Epirubicin + Cisplatin + Capecitabine (ECX) in routine clinical practice in a network of public hospitals in Santiago, Chile. |
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Detailed Description | Chile belongs to the countries with a high mortality rate due to gastric cancer, and this disease is the most frequent cause of cancer death in Chile. Despite of adequate surgery, survival rates are disappointing, with less than 60% of patients for all stages achieving to be alive at 5 years. This is due to the fact that frequently gastric cancer is diagnosed at an advanced stage. For locally advanced gastric cancer a multimodality treatment is recommended, with the alternatives of surgery followed by chemotherapy (asian approach), surgery followed by chemoradiation (US approach) and perioperative chemotherapy (european approach). These three strategies are valid standard treatment options and have shown to improve overall survival in stage IB to IVA gastric cancer. Perioperative chemotherapy administered pre- and postoperatively, has shown to downstage the tumor, increase curative resection, progression free and overall survival. For patients with potentially resectable gastric cancer staged T2 or higher or cN+, NCCN Guidelines recommend perioperative chemotherapy (category1). Chilean guidelines for gastric cancer state the alternative of perioperative chemotherapy, however this approach has not been used widely in public hospitals because lack of financial support. Some gastric cancers overexpress HER2, and this subset of patients benefit from targeted therapy at an advanced stage. The proportions of patients with these molecular characteristics vary widely depending of the geographic area. The chilean population has been investigated in small series, but the incidence of HER2 positive gastric cancer is not known. We therefore plan to measure HER2 expression in all participating patients. |
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Study Type ICMJE | Observational | ||||||||
Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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Biospecimen | |||||||||
Sampling Method | Non-Probability Sample | ||||||||
Study Population | Current diagnosis of T3-4 and/or N+ M0 (according to staging system of the American Joint Committee on Cancer 2002) resectable gastric cancer. The resectability has to be confirmed by a surgical oncologist and/or Oncological Committee. |
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Condition ICMJE | Gastric Cancer | ||||||||
Intervention ICMJE | Drug: epirubicin + cisplatin + capecitabine polychemotherapy
EPIRUBICIN (LKM)at a dose of 50 mg/m2 over 15 minutes is administered every 21 days. CISPLATIN (LKM) at a dose of 60 mg/m2 over 4 hours is administered every 21 days. Patients must receive standardized hydration per protocol. CAPECITABINE (Xeloda®) at a dose of 625 mg/m2 BID (i.e. 1250 mg/m2/day) 30 minutes after meals from day 1 to day 21 of every cycle of chemotherapy. Antiemetic therapy:
Other supportive therapy: Loperamide will be prescribed in case of diarrhea. |
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Study Group/Cohort (s) | locally advanced gastric cancer
Patients with resectable, locally advanced cT3-4 and/or N+ gastric carcinoma
Intervention: Drug: epirubicin + cisplatin + capecitabine polychemotherapy |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 75 | ||||||||
Estimated Completion Date | August 2015 | ||||||||
Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 19 Years to 80 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | Chile | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01633203 | ||||||||
Other Study ID Numbers ICMJE | GOCCHI 2009-01 | ||||||||
Has Data Monitoring Committee | No | ||||||||
Responsible Party | Grupo Oncologico Cooperativo Chileno de Investigation | ||||||||
Study Sponsor ICMJE | Grupo Oncologico Cooperativo Chileno de Investigation | ||||||||
Collaborators ICMJE | |||||||||
Investigators ICMJE | |||||||||
Information Provided By | Grupo Oncologico Cooperativo Chileno de Investigation | ||||||||
Verification Date | June 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |