Observational Study of Perioperative Chemotherapy in Gastric Cancer (PRECISO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Grupo Oncologico Cooperativo Chileno de Investigation
Sponsor:
Information provided by (Responsible Party):
Grupo Oncologico Cooperativo Chileno de Investigation
ClinicalTrials.gov Identifier:
NCT01633203
First received: June 30, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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 Intervention
Gastric Cancer
Drug: epirubicin + cisplatin + capecitabine polychemotherapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study of Patients With Locally Advanced Gastric Cancer Treated With Perioperative Chemotherapy and Surgery

Resource links provided by NLM:


Further study details as provided by Grupo Oncologico Cooperativo Chileno de Investigation:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • To evaluate the rates of adverse events of ECX administered preoperatively [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • To evaluate clinical response after three cycles of preoperative ECX [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • To evaluate the surgical morbidity and mortality after three cycles of preoperative CT [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    To evaluate the 3 year progression free survival

  • overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To evaluate the 5 year overall survival (OS) of patients treated with perioperative CT

  • compliance with the planned postoperative therapy [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To evaluate quality of life and patient reported specific symptoms of the patients treated with perioperative CT

  • HER 2 expression [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    To determine the number of patients with HER2 overexpressing gastric cancers


Estimated Enrollment: 75
Study Start Date: August 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
locally advanced gastric cancer
Patients with resectable, locally advanced cT3-4 and/or N+ gastric carcinoma
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.

Other supportive therapy:

Loperamide will be prescribed in case of diarrhea.


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.

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
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.

Criteria

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.
  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: NCT01633203

Contacts
Contact: Bettina G Muller, MD 56-2-2357923 bmuller@gocchi.org
Contact: Zdenka Zlatar, CRA 56-2-2357923 zzlatar@gocchi.org

Locations
Chile
Instituto Nacional del Cáncer Recruiting
Santiago, RM, Chile, 8380455
Contact: Bettina G Muller, MD    56-2-5757245    bmuller@gocchi.org   
Contact: Jose A Sola, MD    56-2-5757244    josenx@gmail.com   
Principal Investigator: Bettina G Muller, MD         
Sub-Investigator: Jose A Sola, MD         
Sponsors and Collaborators
Grupo Oncologico Cooperativo Chileno de Investigation
  More Information

Additional Information:
Publications:
Responsible Party: Grupo Oncologico Cooperativo Chileno de Investigation
ClinicalTrials.gov Identifier: NCT01633203     History of Changes
Other Study ID Numbers: GOCCHI 2009-01
Study First Received: June 30, 2012
Last Updated: June 30, 2012
Health Authority: Chile: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 28, 2014