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Trial record 1 of 1 for:    01038154
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Study to Evaluate the Efficacy of Pravastatin on Survival and Recurrence of Advanced Gastroesophageal Cancer (AGIM-1)

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ClinicalTrials.gov Identifier: NCT01038154
Recruitment Status : Unknown
Verified December 2009 by Hospital Donostia.
Recruitment status was:  Recruiting
First Posted : December 23, 2009
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:
Hospital Donostia

Tracking Information
First Submitted Date  ICMJE December 2, 2009
First Posted Date  ICMJE December 23, 2009
Last Update Posted Date June 27, 2011
Study Start Date  ICMJE November 2009
Estimated Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2009)
all cause mortality [ Time Frame: two years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2009)
free time of disease recurrence [ Time Frame: two years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy of Pravastatin on Survival and Recurrence of Advanced Gastroesophageal Cancer
Official Title  ICMJE Randomized Controlled Study to Evaluate the Efficacy of Pravastatin on Survival and Recurrence of Advanced Gastroesophageal Cancer
Brief Summary The survival of esophageal cancer and stomach cancer (EGC) at 5 years is less than 30%. Pravastatin is a potent inhibitor of HMG-CoA reductase inhibitor that has shown increased survival in patients with advanced hepatocellular carcinoma. The objective is to evaluate the efficacy of treatment (increase in survival and recurrence-free period of the disease) with pravastatin in patients with advanced EGC. The investigators have designed a randomized, controlled and open. Advanced stage was considered for patients with T4 or N1 or M1 according to the TNM classification. It has been estimated sample size per treatment arm of 73 patients (146 patients in total). Randomization was done on a stratified by location (CE or CG). All patients receive hatitual treatment (surgery and / or chemotherapy and / or radiotherapy and / or palliative) for each of their clinical conditions. The experimental group will receive one tablet of 40 mg of pravastatin orally every 24 hours (breakfast) for 2 years. There will be a monthly monitoring of these patients for at least 2 years which includes an analytics. Every 2 months there will be an abdominal-pelvic CT scan to assess progression and treatment response.
Detailed Description
  1. Design: A randomized, controlled, open, parallel group study to assess the survival and disease-free period or progression in patients with advanced CGE over a period of 2 years.
  2. Under study: Patients diagnosed in histology for the first time, advanced-stage CGE and fulfilling the inclusion criteria and none of the exclusion criteria proposed in the Hospital Donostia (San Sebastian) and Hospital de Basurto (Bilbao) .
  3. Inclusion criteria: older than 18 years, esophageal or gastric cancer histologically confirmed (squamous or adenocarcinoma) for the first time, advanced stage (T4 or N1 or M1) according to the fourth edition of TNM classification and signing the informed consent
  4. Exclusion criteria: Patients who routinely take (more than 3 days a week) anti-inflammatory drugs or aspirin, patients receiving oral anticoagulants, fibrates, cyclosporine and oral contraceptives, patients with hypersensitivity to pravastatin, pregnant women being lactation, peripheral neuropathy grade 2 or greater, patients who have been diagnosed in the previous 5 years other than skin cancer tumor that is not melanoma or carcinoma in situ of cervix or bladder, patients receiving chemotherapy or radiotherapy for other of tumor patients in their laboratory parameters before starting the present study transaminases or alkaline phosphatase more than twice the normal value, patients with platelet count less than 100.000/mm3, absolute neutrophil count below 1000/mm3, or patients with evidence of bleeding diathesis or coagulopathy, patients with heart failure than NYHA grade II, patients with creatinine greater than 2 mg / dL, patients over 75 years, asthmatics, patients with physical or mental disability, patients with alcoholism or patients with diseases hereditary muscle
  5. Intervention: Patients were randomized to two groups:

    • Experimental Group: You will receive one tablet of 40 mg of pravastatin Cinfa EFG, orally every 24 hours (at breakfast) for 2 years.
    • Control Group: will not receive pravastatin. All patients receive the prescribed treatment (surgery and / or chemotherapy and / or radiotherapy and / or palliative) based on their stage and clinical situation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Esophageal Cancer
  • Stomach Cancer
Intervention  ICMJE Drug: Pravastatin
Receive one tablet of 40 mg of pravastatin, orally every 24 hours (at breakfast) for 2 years.
Other Name: esophageal cancer and stomach cancer
Study Arms  ICMJE
  • No Intervention: control
    Not Receive pravastatin
  • Experimental: Pravastatin
    Intervention: Drug: Pravastatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 22, 2009)
146
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2012
Estimated Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Over 18 years,
  • Esophageal or gastric cancer histologically confirmed (squamous or adenocarcinoma) for the first time,
  • Advanced stage (T4 or N1 or M1) according to the fourth edition of TNM classification,
  • Signing the informed consent.

Exclusion Criteria:

  • Patients who routinely take (more than 3 days a week) anti-inflammatory drugs or aspirin,
  • Patients receiving oral anticoagulants, fibrates, cyclosporine and oral contraceptives,
  • Patients with hypersensitivity to pravastatin,
  • Pregnant or lactating women,
  • Peripheral neuropathy grade 2 or greater,
  • Patients who have been diagnosed in the previous 5 years other than skin cancer tumor that is not melanoma or carcinoma in situ of cervix or bladder,
  • Patients receiving chemotherapy or radiotherapy for another type of tumor,
  • Patients in their laboratory parameters before starting the present study transaminases or alkaline phosphatase more than twice the normal value,
  • Patients with platelet count less than 100.000/mm3, absolute neutrophil count below 1000/mm3,
  • Patients with evidence of bleeding diathesis or coagulopathy,
  • Patients with heart failure than NYHA grade II,
  • Patients with creatinine greater than 2 mg / dL,
  • Patients over 75 years,
  • Asthmatics,
  • Patients with physical or mental disability,
  • Patients with alcoholism, OR
  • Patients with hereditary muscle disease.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01038154
Other Study ID Numbers  ICMJE AGIM-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Luis Bujanda. Department of Gastroenterology. Hospital Donostia. Osakidetza.
Study Sponsor  ICMJE Hospital Donostia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Luis Bujanda, Prof. Osakidetza
PRS Account Hospital Donostia
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP