NCT01038154

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2009

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

June 27, 2011

Status Verified

December 1, 2009

Enrollment Period

2 years

First QC Date

December 2, 2009

Last Update Submit

June 24, 2011

Conditions

Esophageal CancerStomach Cancer

Keywords

advanced esophageal cancer and stomach cancerPravastatinSurvivaladverse effects

Outcome Measures

Primary Outcomes (1)

  • all cause mortality

    two years

Secondary Outcomes (1)

  • free time of disease recurrence

    two years

Study Arms (2)

control

NO INTERVENTION

Not Receive pravastatin

Pravastatin

EXPERIMENTAL
Drug: Pravastatin

Interventions

PravastatinDRUG

Receive one tablet of 40 mg of pravastatin, orally every 24 hours (at breakfast) for 2 years.

Also known as: esophageal cancer and stomach cancer
Pravastatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department Gastroenterology. Hospital Donostia

San Sebastián, Guipúzcoa, 20014, Spain

RECRUITING

MeSH Terms

Conditions

Esophageal NeoplasmsStomach Neoplasms

Interventions

Pravastatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Luis Bujanda, Prof.

    Osakidetza

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Bujanda, Prof.

CONTACT

34-943007173luis.bujanda@osakidetza.net

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 23, 2009

Study Start

November 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2012

Last Updated

June 27, 2011

Record last verified: 2009-12

Locations

ES(1)