- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04245644
Efficacy of Chemopreventive Agents on Disease-free and Overall Survival in Patients With Pancreatic Ductal Adenocarcinoma: The CAOS Study (CAOS)
The evidence on the value of aspirin, statins, metformin, beta-blocking ACE inhibitors agents as chemopreventive agents in patients with pancreatic ductal adenocarcinoma is limited.
The aim of this study is to assess whether regular use of aspirin, statins, metformin, angiotensin converting enzyme (ACE)-inhibitors and beta-blocking agents use, before diagnosis, after surgery and in neo-adjuvant treatment setting, can increase rate of disease-free survival (DFS) and overall survival (OS) in participants with pancreatic ductal adenocarcinoma. The secondary aim is to evaluate if there is any difference in terms of "chemoprevention" between aspirin, statins, metformin and beta-blocking as chemopreventive agents, and if their prolonged daily use can positively influence the chemopreventive action.
400 patients with the following inclusion criteria will be enrolled in 3 years:
- cytological or histological diagnosis of pancreatic ductal adenocarcinoma in any portion of the gland, with or without metastases in other sites
- patient age between 18 and 90 years
- any medicine or drug in the daily patient therapy
- Patients undergone to primary chemoradiotherapy or surgical resection, followed by adjuvant therapy or preceded by neoadjuvant chemoradiotherapy, are included in the study Anamnestic, clinical and pathological data, included data on the aspirin, statins, metformin, angiotensin converting enzyme (ACE)-inhibitors and beta-blocking agents assumption will be collected during the first visit with the surgeon. A database managed by a dedicated data manager will be created to collect and analyse data.
Patients will be followed for at least 24 months The study will last overall 5 years.
Study Overview
Status
Intervention / Treatment
Detailed Description
Sample size and Population
This study is designed as a monocentric observational prospective study. In a recent study [9] authors found that the use of low-dose aspirin before and after a diagnosis of pancreatic cancer reduces of 32% the risk of recurrence (Hazard ratio HR=0.68, p<0.01). On the basis of this study and considering that the effect of other drugs as chemopreventive agentsw will be studies, the estimate required sample size to achieve 90% power to detect at least 28% reduction in a hazard of the "drug users" group, by using a two-sided 0.05-level log-rank test, is 400. Therefore, from February 2019 to February 2022, 400 patients with a diagnosis of pancreatic ductal adenocarcinoma at any stage meeting the following inclusion criteria are expected to be enrolled. Median follow-up is estimated to be 24 months after the first disease diagnosis.
Data collection methods
Anamnestic, clinical and pathological data, included data on the aspirin, statins, metformin, angiotensin converting enzyme (ACE)-inhibitors and beta-blocking agents assumption will be collected during the first visit with the surgeon. A database managed by a dedicated data manager will be created to collect and analyse data. The PI will be responsible of the data security.
Statistical analysis
Association between variables will be assessed using the Chi Squared test (or Fisher's exact text where appropriate) for categorical variables and the Spearman's correlation for scale variables. DFS and OS will be estimated using Kaplan-Mayer method and Log Rank tests will be used to evaluate the difference between survival curves. The impact of aspirin, statins, metformin, angiotensin converting enzyme (ACE)-inhibitors and beta-blocking agents on the risk of recurrence will be estimated using Cox regression models. Variables resulting significant (p value <0.05) at univariate analysis or variables which are known prognostic/risk factors will be included in the multivariable regression models. A p value of <0.05 will be considered statistically significant. Statistical analysis will be conducted using SPSS v23 (IBM, Armonk, New York, USA) and R v3.3.0 (https://cran.r-project.org).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Domenico tamburrino, MD
- Phone Number: +390226432324
- Email: tamburrino.domenico@hsr.it
Study Locations
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-
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Milan, Italy, 20132
- IRCCS San Raffaele
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- cytological or histological diagnosis of pancreatic ductal adenocarcinoma in any portion of the glande, with or without metastases in other sites
- patient age between 18 and 90 years
- any medicine or drug in the daily patient therapy
- Patients undergone to primary chemoradiotherapy or surgical resection, followed by adjuvant therapy or preceded by neoadjuvant chemoradiotherapy, are included in the study
Exclusion Criteria:
- age under 18 years
- lack of cytological or histological diagnosis of pancreatic ductal adenocarcinoma
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease free survival
Time Frame: two-years follow-up
|
probability of recurrence or progression of disease in patients on regular treatment with targeted drugs compared with non-users
|
two-years follow-up
|
Overall survival
Time Frame: two-years follow-up
|
risk of death for disease in patients on regular treatment with targeted drugs compared with non-users
|
two-years follow-up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Adenocarcinoma
- Pancreatic Neoplasms
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Protease Inhibitors
- Aspirin
- Metformin
- Angiotensin-Converting Enzyme Inhibitors
Other Study ID Numbers
- CAOS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Sidney Kimmel Cancer Center at Thomas Jefferson...CelgeneWithdrawnPancreatic Ductal Adenocarcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
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University of NebraskaNational Cancer Institute (NCI)CompletedPancreatic Adenocarcinoma | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage II Pancreatic Cancer | Stage I Pancreatic Cancer | Resectable Pancreatic Carcinoma | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
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