Study to Evaluate the Efficacy of Pravastatin on Survival and Recurrence of Advanced Gastroesophageal Cancer (AGIM-1)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Hospital Donostia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Donostia
ClinicalTrials.gov Identifier:
NCT01038154
First received: December 2, 2009
Last updated: June 24, 2011
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Stomach Cancer
Drug: Pravastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study to Evaluate the Efficacy of Pravastatin on Survival and Recurrence of Advanced Gastroesophageal Cancer

Resource links provided by NLM:


Further study details as provided by Hospital Donostia:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • free time of disease recurrence [ Time Frame: two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 146
Study Start Date: November 2009
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
Not Receive pravastatin
Experimental: Pravastatin Drug: Pravastatin
Receive one tablet of 40 mg of pravastatin, orally every 24 hours (at breakfast) for 2 years.
Other Names:
  • Pravastatin
  • esophageal cancer and stomach cancer

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01038154

Contacts
Contact: Luis Bujanda, Prof. 34-943007173 luis.bujanda@osakidetza.net

Locations
Spain
Department Gastroenterology. Hospital Donostia Recruiting
San Sebastián, Guipúzcoa, Spain, 20014
Contact: Luis Bujanda, Prof.    34-943007173    luis.bujanda@osakidetza.net   
Sponsors and Collaborators
Hospital Donostia
Investigators
Principal Investigator: Luis Bujanda, Prof. Osakidetza
  More Information

No publications provided

Responsible Party: Luis Bujanda. Department of Gastroenterology. Hospital Donostia. Osakidetza.
ClinicalTrials.gov Identifier: NCT01038154     History of Changes
Other Study ID Numbers: AGIM-1
Study First Received: December 2, 2009
Last Updated: June 24, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Donostia:
advanced esophageal cancer and stomach cancer
Pravastatin
Survival
adverse effects

Additional relevant MeSH terms:
Esophageal Neoplasms
Recurrence
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Disease Attributes
Pathologic Processes
Stomach Diseases
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014