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

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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Esophageal Cancer; Stomach Cancer	Drug: Pravastatin	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 146 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Study to Evaluate the Efficacy of Pravastatin on Survival and Recurrence of Advanced Gastroesophageal Cancer
• Study Start Date: November 2009
• Estimated Primary Completion Date: November 2011
• Estimated Study Completion Date: November 2012

Arms and Interventions

Arm	Intervention/treatment
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 Name: esophageal cancer and stomach cancer

Outcome Measures

Primary Outcome Measures :

1. all cause mortality [ Time Frame: two years ]

Secondary Outcome Measures :

1. free time of disease recurrence [ Time Frame: two years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Luis Bujanda. Department of Gastroenterology. Hospital Donostia. Osakidetza.
• ClinicalTrials.gov Identifier: NCT01038154
• Other Study ID Numbers: AGIM-1
• First Posted: December 23, 2009
• Last Update Posted: June 27, 2011
• Last Verified: December 2009

Keywords provided by Hospital Donostia:

advanced esophageal cancer and stomach cancer; Pravastatin; Survival; adverse effects

Additional relevant MeSH terms:

Esophageal Neoplasms; Stomach Neoplasms; Recurrence; Disease Attributes; Pathologic Processes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Pravastatin; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors