A Phase 3 Randomized, Open-Label Study Comparing Pexa-Vec (Vaccinia GM-CSF / Thymidine Kinase-Deactivated Virus) Followed by Sorafenib Versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC) Without Prior Systemic Therapy Save

Date Added
June 27th, 2017
PRO Number
Pro00066060
Researcher
Juan Camacho
Keywords
Cancer, Cancer/Gastrointestinal, Liver, Men's Health, Vaccine, Women's Health
Summary

This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A ?Window Trial? On Boswellia, An Extract From Frankincense, For Breast Cancer and Colon Cancer Primary Tumors Save

Date Added
June 20th, 2017
PRO Number
Pro00067127
Researcher
Nancy Demore
Keywords
Cancer/Breast, Cancer/Gastrointestinal
Summary

The overall goal of this study is to see if taking BosPure (boswellia serrata) will change the make up of the tumors of patients who have breast and colon cancer. BosPure is a supplement made from the boswellia serrata plant, which helps to reduce inflammation in the body. BosPure is not approved by the United State Food and Drug Administration (FDA) for the treatment of your disease.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-cto-clinops@musc.edu

Preoperative Extended Chemotherapy vs. Chemotherapy Plus Hypofractionated Radiation Therapy for Borderline Resectable Adenocarcinoma of the Head of the Pancreas Save

Date Added
March 21st, 2017
PRO Number
Pro00063042
Researcher
David Marshall
Keywords
Cancer/Gastrointestinal, Pancreas
Summary

This study is for men and women with pancreatic cancer that cannot be removed by surgery this time. The purpose of this study is to compare any good and bad effects of using chemotherapy compared to chemotherapy and radiation prior to surgery. This study will allow the researchers to know whether which approach is better, the same, or worse than the other.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A 5-year Longitudinal Observational Study of the Natural History and Management of Patients with Hepatocellular Carcinoma Save

Date Added
February 28th, 2017
PRO Number
Pro00062918
Researcher
David Koch
Keywords
Cancer, Cancer/Gastrointestinal, Cancer/Other, Digestive System, Genetics, Liver, Obesity, Weight Control
Summary

TARGET-HCC is a 5-year, longitudinal, observational study of the natural history and management of patients with HCC. The study will address important clinical questions that remain unanswered in the management of HCC with a unique research registry of participants with HCC from academic and community real-world practices. TARGET-HCC is disease focused, not drug specific, which allows for continuous acquisition of real-world evidence regarding the natural history, management, and outcomes of treatment with current therapies and new treatments that may be utilized in usual clinical practice.

Institution
MUSC
Recruitment Contact
Francis Beylotte
843-876-4273
beylott@musc.edu

The Influence of Colorectal Cancer Risk Factors within Normal Colonic Mucosa and Colon Polyps: A Feasibility Study Save

Date Added
January 17th, 2017
PRO Number
Pro00060146
Researcher
Kristin Wallace
Keywords
Cancer, Cancer/Gastrointestinal, Colonoscopy, Disease Prevention, Immune System, Inflammation, Minorities
Summary

The purpose of the study is to determine the feasibility of enrolling patients, obtaining colorectal cancer risk factor data via an in-person questionnaire, and procuring three types of biologic samples (normal mucosa biopsies, a salvia sample, and polyp tissue (if applicable)).

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
8438762445
blanke@musc.edu

A Pragmatic Trial to Evaluate a Guideline-Based Colony Stimulating Factor Standing Order Intervention and to Determine the Effectiveness of Colony Stimulating Factor Use as Prophylaxis for Patients Receiving Chemotherapy with Intermediate Risk for Febrile Neutropenia ?Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER) Save

Date Added
November 16th, 2016
PRO Number
Pro00061360
Researcher
James Bearden
Keywords
Cancer, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Lung
Summary

Some drugs used to treat cancer raise a patient?s risk of febrile neutropenia. Febrile neutropenia is a condition that involves a fever and a low number of neutrophils (a type of white blood cell) in the blood. Having a low number of neutrophils puts a patient at risk of infection. Colony-stimulating factors (CSFs) are medications sometimes given to patients getting cancer treatment to prevent or treat febrile neutropenia. CSFs are given as an injection under the skin or into a vein.

Current guidelines say that doctors should give CSF during cancer treatment based on how likely it is that the drugs will raise the risk of febrile neutropenia. Research shows that many doctors do not follow these guidelines. This may be harming patients. Underuse of CSFs can raise a patient's risk for febrile neutropenia. Overuse or unneeded use of CSFs can lead to side effects, like bone and muscle pain, but give no benefit and can be costly to the patient.

In some clinics there is an automated system that helps doctors decide when to use CSFs. The system prescribes CSFs when there is a high risk that the drugs will cause febrile neutropenia. It does not prescribe CSFs when there is a low risk that the drugs will cause febrile neutropenia. The research study team wants to find out if this type of system can help doctors use CSF when it is needed and not use it when it is not needed. The study team also wants to learn about the benefits and risks of using CSF with cancer treatment drugs that have a moderate (not high and not low) risk of febrile neutropenia.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

Implementation of a Prospective Financial Impact Assessment Tool in Patients with Metastatic Colorectal Cancer Save

Date Added
September 14th, 2016
PRO Number
Pro00056172
Researcher
Daniel Reuben
Keywords
Cancer/Gastrointestinal
Summary

This study is for men and women who have colorectal cancer. The study is looking at the financial impact of colorectal cancer.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Implementation of a Prospective Financial Impact Assessment Tool in Patients with Metastatic Colorectal Cancer Save

Date Added
July 21st, 2016
PRO Number
Pro00057833
Researcher
James Bearden
Keywords
Cancer, Cancer/Gastrointestinal, Non-interventional
Summary

Studies have shown that cancer patients may be at high risk for financial problems because of the cost of treatment. These financial problems can be stressful and sometimes might cause patients to avoid or refuse treatment. We want to measure how often financial problems happen in patients with colorectal cancer, using questionnaires that collect information about finances and quality of life. In order to get a full picture of the financial impact of colorectal cancer, we also want to collect credit reports for all patients in this study.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

Pancreatic Cancer Radiotherapy Study Group (PanCRS) Trial: A Randomized Phase III Study Evaluating Modified FOLFIRINOX (mFFX) with or without Stereotactic Body Radiotherapy (SBRT) in the Treatment of Locally Advanced Pancreatic Cancer Save

Date Added
June 21st, 2016
PRO Number
Pro00053734
Researcher
David Marshall
Keywords
Cancer, Cancer/Gastrointestinal, Men's Health, Pancreas, Women's Health
Summary

The goal of this study is to determine the safety and efficacy of a chemotherapy regimen known as Modified FOLFIRINOX (mFFX) alone or with the addition of Stereotactic Body Radiotherapy (SBRT). SBRT is a type of highly focused and precise x-ray treatment done in a total of 5 treatments. We hope to learn if this new treatment combination helps to control the disease and improve survival for patients with locally advanced pancreatic cancer.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

An International Multicentre Open Label Randomised Phase II Advanced Anal Cancer Trial Comparing Cisplatin plus 5-fluorouracil versus Carboplatin plus Weekly Paclitaxel in Patients with Inoperable Locally Recurrent or Metastatic Disease Save

Date Added
May 17th, 2016
PRO Number
Pro00053042
Researcher
Paul O'brien
Keywords
Cancer, Cancer/Gastrointestinal
Summary

This study is for patients who have anal cancer that has returned following initial treatment or has spread to other areas of their body. The main purpose of this study is to establish the standard of care for advanced or metastatic anal cancer.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

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