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
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|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Stomach Cancer||Drug: Pravastatin||Phase 4|
- 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.
- 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) .
- 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
- 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
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
No Intervention: control
Not Receive 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
- all cause mortality [ Time Frame: two years ]
- free time of disease recurrence [ Time Frame: two years ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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,
- Patients with physical or mental disability,
- Patients with alcoholism, OR
- Patients with hereditary muscle disease.
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 ClinicalTrials.gov identifier (NCT number): NCT01038154
|Contact: Luis Bujanda, Prof.||email@example.com|
|Department Gastroenterology. Hospital Donostia||Recruiting|
|San Sebastián, Guipúzcoa, Spain, 20014|
|Contact: Luis Bujanda, Prof. 34-943007173 firstname.lastname@example.org|
|Principal Investigator:||Luis Bujanda, Prof.||Osakidetza|
|Responsible Party:||Luis Bujanda. Department of Gastroenterology. Hospital Donostia. Osakidetza.|
|Other Study ID Numbers:||
|First Posted:||December 23, 2009 Key Record Dates|
|Last Update Posted:||June 27, 2011|
|Last Verified:||December 2009|
advanced esophageal cancer and stomach cancer
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors