Randomized Controlled Study to Evaluate the Efficacy of Pravastatin on Survival and Recurrence of Advanced Gastroesophageal Cancer
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
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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
all cause mortality
Luis Bujanda, Prof.
Spain: Spanish Agency of Medicines