Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Syndrome

Colorectal Neoplasms

Colorectal Neoplasms, Hereditary Nonpolyposis

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Neoplastic Syndromes, Hereditary

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Genetic Diseases, Inborn

DNA Repair-Deficiency Disorders

Metabolic Diseases

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

All Drugs and Chemicals

Lipid Regulating Agents

Aspirin

Atorvastatin

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Atorvastatin (LIPITOR) 20 milligram tablet daily for 6 weeks

Atorvastatin (LIPITOR) 20 milligram tablet and Aspirin 325 mg tablet daily for 6 weeks

No history of colorectal cancer and no colorectal adenomas within 5 years.

Atorvastatin 20mg

History of colorectal cancer and/or history of colorectal adenomas within 5 years.

Atorvastatin 20mg AND Aspirin 325 mg

Yana Chertock, MA

Michael Hall, MD, MS

Michael J Hall, MD, MS

Margie L Clapper, PhD

Minhhuyen T Nguyen, MD,AGAF,FACP

Harry S Cooper, MD

Wen-Chi L Chang, PhD

The goal of this study is to investigate that a common cholesterol lowering agent (atorvastatin) alone or combining with a nonsteroidal anti-inflammatory drug (aspirin) would reduce the risk of colorectal cancer (CRC) in high-risk individuals with Lynch syndrome.

This is an exploratory biomarker trial to assess the ability of atorvastatin (common cholesterol lowering agent) alone or combining with aspirin (a nonsteroidal anti-inflammatory drug) to reduce the risk of colorectal cancer in high-risk individuals with Lynch Syndrome. Subjects will be stratified based on their prior history of polyps/cancer to receive atorvastatin without or with aspirin for 6 weeks. Blood and normal colon biopsies will be obtained at Day 0 and at 6 weeks on study. Tissue endpoints for analysis include cell proliferation, apoptosis and changes in gene expression. Circulating lipid profiles and metabolic function, and post-treatment questionnaires will be used to assess the acceptability of the study.

One group receives atorvastatin 20 mg, and the other group receives atorvastatin 20 mg+ aspirin 325mg

Atorvastatin ± Aspirin in Lynch Syndrome Syndrome

Impact of Atorvastatin ± Aspirin on Colorectal Biomarkers in Patients With Lynch Syndrome: a Pilot Study

Individual participant data that underline the results reported in the article , after de-identification

Effect of Atorvastatin or/and Aspirin on normal colonic proliferation and apoptosis will be evaluated by comparing of immunohistochemical staining of Ki-67 and active caspase 3 using formalin-fixed paraffin-embedded biopsies collected before and at the 6 weeks of drug treatments. Number of positive cells and total number of evaluated cells will be collected for both assays. Data of cells with positive Ki-67 or active caspase 3 will be expressed as % of positive cells (# positive cells/#total evaluated cells x 100). Statistical analyses will be performed to compare the difference between baseline and 6-weeks data.

Effect of Atorvastatin or/and Aspirin on gene expressions in normal colonic epithelial cells will be analyzed using RNA-Seq. Total RNA will be extracted from frozen biopsies. RNASeq libraries will be generated and sequenced on an Illumina platform and analyzed. Differential expression between samples at baseline and 6-weeks of drug treatment will be assessed for statistical significance. Genes with false discovery rat ≤ 0.05 and a fold-change ≥ 2 will be considered significant.

Medication Adherence to the 6-week course of Atorvastatin or/and Aspirin preventive therapy will be assessed by one question in the follow -up survey which participants complete at the end of the study :"Over 6 weeks of preventive therapy, how many Atorvastatin/Aspirin pills did you forget to take?" In addition, participants will be asked to return medication bottle(s) with or without pills. RA will count pills and record number of missing pills in the system.

The adverse event assessment form is used to collect initial and follow-up information for non-serious and serious adverse events for patients participating in the study. Participants are contacted by RA every two weeks to assess side effects and toxicity. A grading scale from 1 to 5 (1-mild, 2-moderate, 3-severy, 4-life-threatining, 5- death related to AE) and causality (1-unrelated, 2-unlikly, 3-possible, 4-probable, 5-definite, NA- not assessed) are recorded for each adverse event (AE) term. Each AE is reviewed by principal investigator and entered into patient's electronic medical record (EMR)

Acceptability of the study approach 6 Likert-type items (7 point scale) will assess participants' perceptions of various aspects of the study design as a measure of whether changes need to be made to the study methods or design prior to a larger multi-institutional trial. Participants' scores will be summed and a mean score generated. Mean scores \> 4 will be considered in the acceptable range. Our threshold target is 75% of participants with a mean score in the acceptable range.

Fox Chase Cancer Center

Rare Diseases

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

Temozolomide

According to the clinical standard dose of lipid-lowering drugs, the subjects were enrolled in this study. After 2 weeks of glioma surgery, one tablet of liptor was taken orally every night on the basis of STUPP protocol.

Liptor is a capsule in the form of 20 mg, once daily.

Chunsheng Kang

Xiaoteng Cui

Glioblastoma (GBM) is the primary intracranial malignant tumor with the highest morbidity and mortality, and the 5-year survival rate is less than 10%. The number of primary diagnostic patients and deaths of GBM in China ranks first in the world every year, which seriously threatens people's life and health. At present, the clinical treatment strategy of maximum surgical resection combined with concurrent chemo- and radio-therapy and TTF treatment is still not satisfactory, and the median survival time of GBM patients is only 14.4 months. Statins inhibit cholesterol production with few side effects and are widely used for cholesterol control in patients with hyperlipidemia. In recent years, statins have shown good anti-tumor effect. Our previous study found that statins can block the malignant progression of glioma mediated by EGFR pathway. Therefore, the investigators report a clinical study protocol designed to evaluate the clinical efficacy of a comprehensive treatment strategy of atorvastatin (ATO) combined with temozolomide (TMZ) in primary and recurrent glioblastomas with high EGFR expression.

The investigators designed a multicenter, single-arm, double-blind, phase II clinical trial to evaluate the efficacy and safety of oral ATO combined with TMZ in EGFR-high expressing GBM. After informed consent was signed by the patient or authorized family members, the patients were treated with the current STUPP regimen and ATO (20mg, qn) orally. The patients were regularly followed up for 52 weeks after treatment. The primary endpoint was progression-free survival (PFS), which was defined as the time from the start of GBM surgery to tumor progression (recurrence) or death. The secondary end point was the rate of tumor control, which was defined as the proportion of patients with a complete response, a partial response, or a stable disease that had shrunk or remained stable for a given period of time. Safety will be assessed during the study by monitoring of regular MRI scans, laboratory tests (liver function, lipid profile, blood routine), electrocardiography, vital signs (blood pressure, pulse, temperature), and weight.

The results of this clinical trial will provide key information on whether the oral combination of atorvastatin and temozolomide prolongs PFS in EGFR-high GBM patients with efficacy and safety.

Evaluate the Efficacy and Safety of Atorvastatin Combined With Temozolomide in the Treatment of Glioblastoma

According to the clinical standard dose of lipid-lowering drugs, the subjects were enrolled in this study. After 2 weeks of glioma surgery, one tablet of liptor was taken orally every night on the basis of other treatments.

This outcome is evaluation of hepatic burden of GBM patients after receiving atorvastatin administration. Since participant is enrolled in this research, peripheral blood will be collected for testing ALT, AST, GGT, ALP, TP, ALB, GLB, A/G, TBIL, DBIL, and IBIL. The physiological parameters of these index are as follows: ALT: 0\~40 U/L; AST: 0\~40 U/L; GGT: 0\~40 U/L; ALP: 40\~110 U/L; TP: 65\~85 g/L; ALB: 40\~55 g/L; GLB: 20\~40 g/L; A/G: 1.5\~2.5: 1; TBIL: 0\~23 μmol/L; DBIL: 0\~8 μmol/L; IBIL: 1\~14 μmol/L.

This outcome is evaluation of safety and tolerability during combination therapy of atorvastatin and STUPP protocol. Percentage of participants with treatment-related adverse events as assessed by CTCAE v5.0.

Tianjin Medical University General Hospital

Principal Investigator, Clinical Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Choung-Soo Kim, MD

Biochemical recurrence develops in approximately 30-40% of men with locally advanced prostate cancer who undergo radical prostatectomy. To date, the effect of statins on prostate cancer recurrence has been investigated in several retrospective studies with inconsistent results. The purpose of this study is to determine the impact of statin on biochemical recurrence after radical prostatectomy for locally advanced prostate cancer.

Estimated Enrollment: 354

Study start date: October 2012

Estimated Study Completion Date: October 2015

Statin Group: Treatment with Atorvastatin 20mg daily after radical prostatectomy during 1 year.

Control Group: Treatment with Placebo daily after radical prostatectomy during 1 year.

Follow up: every 3 months for the first year. Check PSA, Total/LDL-cholesterol and Triglyceride.

Primary End Point Rate of Biochemical recurrence

Secondary End Point Clinical progression of prostate cancer Change of Total/LDL- cholesterol and Triglycerides 5 year-Biochemical recurrence free survival

Impact of Adjuvant Statin Therapy in Patients Who Underwent Radical Prostatectomy for Locally Advanced Prostate Cancer

A Randomized Double Blind, Placebo-controlled Study Determining the Role of Adjuvant Statin Therapy in Patients Who Underwent Radical Prostatectomy for Locally Advanced Prostate Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Atorvastatin ± Aspirin in Lynch Syndrome Syndrome	NCT04379999	Lynch Syndrome	Atorvastatin 20... Atorvastatin 20...	18 Years - 75 Years	Fox Chase Cancer Center
Evaluate the Efficacy and Safety of Atorvastatin Combined With Temozolomide in the Treatment of Glioblastoma	NCT06327451	Glioblastoma, I...	Atorvastatin 20...	18 Years - 60 Years	Tianjin Medical University General Hospital
Impact of Adjuvant Statin Therapy in Patients Who Underwent Radical Prostatectomy for Locally Advanced Prostate Cancer	NCT01759836	Prostatic Neopl...	Atorvastatin 20...	-	Asan Medical Center
Impact of Adjuvant Statin Therapy in Patients Who Underwent Radical Prostatectomy for Locally Advanced Prostate Cancer	NCT01759836	Prostatic Neopl...	Atorvastatin 20...	-	Asan Medical Center

Spots Global Cancer Trial Database for atorvastatin 20mg