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Observational Study of Perioperative Chemotherapy in Gastric Cancer (PRECISO)

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. Identifier: NCT01633203
Recruitment Status : Unknown
Verified March 2017 by Grupo Oncologico Cooperativo Chileno de Investigation.
Recruitment status was:  Active, not recruiting
First Posted : July 4, 2012
Last Update Posted : March 7, 2017
Information provided by (Responsible Party):
Grupo Oncologico Cooperativo Chileno de Investigation

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.

Condition or disease Intervention/treatment
Gastric Cancer Drug: epirubicin + cisplatin + capecitabine polychemotherapy

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 : Observational
Actual Enrollment : 61 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study of Patients With Locally Advanced Gastric Cancer Treated With Perioperative Chemotherapy and Surgery
Study Start Date : August 2010
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : September 2018

Group/Cohort Intervention/treatment
locally advanced gastric cancer
Patients with resectable, locally advanced cT3-4 and/or N+ gastric carcinoma treated with 3 perioperative epirubicin cisplatin capecitabine polychemotherapy
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:

  • Dexamethasone 8 mg IV and Ondansetron (LKM) 8 mg IV o Granisetron (Kytril®) prior to chemotherapy
  • Rescue Ondansetron (LKM) 8 mg IV will be given during 24-hour hospitalization in case of emesis
  • Symptomatic antiemetic therapy with thiethylperazine will be prescribed.

Loperamide will be prescribed in case of diarrhea.

Primary Outcome Measures :
  1. rate of downstaging [ Time Frame: 3 months ]
    To determine the rate of downstaging of locally advanced cT3-4 and/or N+ gastric carcinomas after 3 cycles of preoperative chemotherapy with ECX

Secondary Outcome Measures :
  1. To evaluate the rates of adverse events of ECX administered preoperatively [ Time Frame: 3 months ]
  2. To evaluate clinical response after three cycles of preoperative ECX [ Time Frame: 3 months ]
  3. To evaluate the surgical morbidity and mortality after three cycles of preoperative CT [ Time Frame: 5 months ]
  4. progression free survival [ Time Frame: 3 years ]
    To evaluate the 3 year progression free survival

  5. overall survival [ Time Frame: 5 years ]
    To evaluate the 5 year overall survival (OS) of patients treated with perioperative CT

  6. compliance with the planned postoperative therapy [ Time Frame: 7 months ]
  7. quality of life [ Time Frame: 5 years ]
    To evaluate quality of life and patient reported specific symptoms of the patients treated with perioperative CT

  8. HER 2 expression [ Time Frame: 5 months ]
    To determine the number of patients with HER2 overexpressing gastric cancers

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria:

  • Histologically proven invasive carcinoma
  • Age > 18 years.
  • ECOG performance status 0 or 1.
  • Hemoglobin > 9 g/dL
  • Absolute neutrophil count > 1.5 x 109/L
  • Platelet count > 100 x 109/L
  • Creatinine < 1.5 ULN
  • Creatinine clearance > 60 mL/min
  • Serum bilirubin < 1.5 x ULN
  • AST < 2.5 x ULN
  • Women of child bearing potential: must agree to use an effective contraceptive method.
  • Signed informed consent.

Exclusion Criteria:

  • ECOG > 2.
  • Pre-existing diarrhea uncontrolled with supportive care.
  • Inability to swallow Xeloda tablets.
  • History of mild-to-moderate renal insufficiency (creatinine clearance < 45 mL/min).
  • Signs or symptoms of clinically significant hepatic dysfunction (bilirubin > 1.5 ULN, FA > 2.5 ULN, albumin < 2,5 g/dL).
  • Significant cardiac dysfunction (LVEF < LLN)
  • Presence of distant metastasis, including clinical signs of peritoneal carcinomatosis
  • Symptomatic gastric retention or severe dysphagia with a caloric intake of < 1500 kcal/day
  • Histology of lymphoma, GIST or neuroendocrine tumor
  • Pregnant or breast-feeding women. Female patients must be postmenopausal, surgically sterile or they must agree to use an effective method of contraception.
  • Any medical conditions that, in the investigator's opinion, would impose excessive risk to the patient. Examples of such conditions include congestive heart failure of Class III or IV of the NYHA classification, infection requiring parental or oral treatment, any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01633203

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Instituto Nacional del Cáncer
Santiago, RM, Chile, 8380455
Sponsors and Collaborators
Grupo Oncologico Cooperativo Chileno de Investigation
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Principal Investigator: Bettina G Muller, MD Grupo Oncologico Cooperativo Chileno de Investigation

Additional Information:
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Responsible Party: Grupo Oncologico Cooperativo Chileno de Investigation Identifier: NCT01633203     History of Changes
Other Study ID Numbers: GOCCHI 2009-01
First Posted: July 4, 2012    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD are planned to be shared once the final results have been published, foreseen for 2018, data include all datapoints incorporated in the anonymized data base. The investigators who wish to use the data should submit the protocol (approved by an IRB) and the request to access the database to GOCCHI (

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Grupo Oncologico Cooperativo Chileno de Investigation:
gastric cancer
combination chemotherapy
HER-2 gene
quality of life

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors