FIGHT: A Phase 3 Randomized, Double-Blind, Controlled Study Evaluating FPA144 and Modified FOLFOX6 in Patients with Previously Untreated Advanced Gastric and Gastroesophageal Cancer: Phase 3 Preceded by Dose-Finding in Phase 1 Save

Date Added
November 30th, 2018
PRO Number
Pro00079574
Researcher
Carolyn Britten

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies
Summary

The purpose of this study is to evaluate the safety and effectiveness of a new investigational compound, called FPA144, in combination with chemotherapy (a combination of 5-fluorouracil, oxaliplatin, and leucovorin called mFOLFOX6), for the treatment of gastric and/or gastroesophageal cancer and other solid tumors. The entire study (Phase 1 and Phase 3) is expected to take about 66 months to complete. MUSC is participating in the phase 3 portion only.

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

A Humanitarian Device Exemption Treatment Protocol of TheraSphere For Treatment of Unresectable Primary Liver Cancer Save

Date Added
November 6th, 2018
PRO Number
Pro00081570
Researcher
Ricardo Yamada

List of Studies

Silhouette
Keywords
Cancer/Gastrointestinal, Liver
Summary

TheraSphere® is a humanitarian use device (HUD) for treating cancer that originates in the liver. TheraSphere® consists of millions of tiny glass beads containing radioactive yttrium-90. The glass radioactive beads (20-30 micrometers in diameter ? about a third of the width of a human hair) are delivered directly to the liver tumors. It can be used to downstage tumors to become eligible for surgery or transplantation. It is also the only medical device approved in the United States to treat primary liver cancer patients with portal vein thrombosis (PVT). TheraSphere® has been approved as an HUD based upon its safety and probable benefit.

Institution
MUSC
Recruitment Contact
Susan Norton
843 814 8874
nortons@musc.edu

A Randomized Phase II Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer Save

Date Added
September 26th, 2018
PRO Number
Pro00082302
Researcher
Carolyn Britten

List of Studies


Profiles_link
Keywords
Cancer/Gastrointestinal
Summary

This study is for patients who have anal cancer that has a high likelihood of returning. The purpose of this study is to find if adding the study drug, nivolumab (also known as OPDIVO®), after standard chemotherapy {(mitomycin-C and 5-fluorouracil (5-FU) or capecitabine) or 5-FU and cisplatin} and radiation will prevent the anal cancer from returning.

Institution
MUSC
Recruitment Contact
Barbara Roe
843-652-1607
broe@tidelandshealth.org

Longitudinal Assessment of Financial Burden in Patients with Colon or Rectal Cancer Treated with Curative Intent Save

Date Added
September 6th, 2018
PRO Number
Pro00081552
Researcher
Carolyn Britten

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Gastrointestinal
Summary

Patients will complete questionnaires at 5 time points over 24 months (within 60 days of diagnosis, then at 3, 6, 12 and 24 months after diagnosis). Surveys can be done either on paper or online. It is estimated that it will take 45-60 minutes to complete the first questionnaire and 20-30 minutes to complete the 3, 6, 12 and 24 month questionnaires. Information requested will be about the patient's finances and employment, as well as basic demographic information which will be obtained from the patient's medical records. Patients will be asked to provide their contact information to the ECOG-ACRIN Outcomes and Economics Assessment Unit at Brown University, which will administer the surveys.

Institution
MUSC
Recruitment Contact
Barbara Roe
843-652-1607
broe@tidelandshealth.org

A Phase III Study of BBI-608 plus nab-Paclitaxel with Gemcitabine in Adult Patients with Metastatic Pancreatic Adenocarcinoma Save

Date Added
June 28th, 2018
PRO Number
Pro00073638
Researcher
Carolyn Britten

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies, Pancreas
Summary

The purpose of this study is to find out whether patients with pancreatic cancer will live longer when receiving treatment with nab-Paclitaxel and Gemcitabine, a standard chemotherapy regimen, given in combination with a new drug, BBI-608, or live longer when receiving treatment with nab-Paclitaxel and Gemcitabine alone for pancreatic cancer. The length of participation for this study will continue until your doctor feels you are no longer benefitting from your treatment. This study is expected to take 2-3 years to complete. This research is being done to improve on existing treatments for pancreatic cancer.

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

A Phase 1b (Open-Label) / Phase 2 (Randomized, Double-Blinded) Study Evaluating Nab-Paclitaxel and Gemcitabine With or Without Olaratumab in the Treatment of First-Line Metastatic Pancreatic Cancer Save

Date Added
March 27th, 2018
PRO Number
Pro00075360
Researcher
Carolyn Britten

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies, Pancreas
Summary

This study is to determine the safety and efficacy of nab-paclitaxel and gemcitabine with or without olaratumab in the treatment of first-line metastatic pancreatic cancer. There is not a set number of clinic visits and subjects can remain on study provided their disease is at least stable for each imaging time point, and if study drugs are sufficiently tolerated

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

Randomized Trial of Standard Chemotherapy Alone or Combined With Atezolizumab as Adjuvant Therapy for Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair Save

Date Added
January 31st, 2018
PRO Number
Pro00073086
Researcher
Paul O'brien

List of Studies

Silhouette
Keywords
Cancer/Gastrointestinal
Summary

This study is for men and women with colon cancer that was surgically removed but has spread to lymph nodes and is known as stage III colon cancer. The purpose of this study is to compare any good and bad effects of using the drug atezolizumab along with the usual chemotherapy compared to the usual chemotherapy alone.

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

List of Studies


Profiles_link
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

List of Studies


Profiles_link
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

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

List of Studies

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

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