A Single-Site, Parallel-Group, Randomized-Controlled Trial of Navigation Versus Usual Care for The Management of Delays and Racial Disparities Starting Postoperative Radiation Therapy in Adults with Surgically-Managed, Locally Advanced Head and Neck Squamous Cell Carcinoma (NDURE 2.0) Save

Date Added
July 27th, 2019
PRO Number
Pro00091049
Researcher
Evan Graboyes

List of Studies

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Keywords
Cancer/Head & Neck
Summary

The purpose of this study is to evaluate whether a new patient navigation intervention can decrease delays starting radiation therapy after surgery for white and African-American head and neck cancer patients. Patients who have surgery and radiation for certain types of head and neck cancer are eligible for this study.

Institution
MUSC
Recruitment Contact
Courtney Marsh
(843) 792-0719
marshch@musc.edu

A Phase II Study of Durvalumab (MEDI 4736) with Radiotherapy for the adjuvant treatment of Intermediate Risk Head and Neck Squamous Cell Carcinoma Save

Date Added
July 23rd, 2019
PRO Number
Pro00089876
Researcher
John Kaczmar

List of Studies

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Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with locally advanced squamous cell carcinoma of the head and neck (SCCHN) and will need additional treatment following surgery. The investigational drug in this study is Durvalumab. The purpose of this study is to investigate other drugs that may be combined with radiation to treat SCCHN. The study focuses on determining whether durvalumab combined with radiation will have improved 3-year disease free survival compared to historical control. Participants can expect to be in this study for 5 years.

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

A Phase 1b Study of ASP1948, Targeting an Immune Modulatory Receptor, as a Single Agent and in Combination with Nivolumab in Subjects with Advanced Solid Tumors Save

Date Added
July 23rd, 2019
PRO Number
Pro00087949
Researcher
John Wrangle

List of Studies

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Keywords
Cancer, Cancer/Breast, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Lung
Summary

The purpose of this study is to determine at what dose the study drug (ASP1948) is safe and tolerated and how it is processed in the blood of patients with tumors that cannot be removed (unresectable) or has spread (metastasized) to a different part of the body. When the safe dose is identified, it will be used to evaluate if the study treatment causes tumors to shrink in patients.The screening period for this study can take up to 28 days. The treatment period consists of up to 48 weeks of initial treatment, followed by up to 45 weeks of follow up. If you quality and are willing to continue in the re-treatment period (receiving the study drug again), you will be in the study for an additional 48 weeks.

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

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma Save

Date Added
July 18th, 2019
PRO Number
Pro00087838
Researcher
John Kaczmar

List of Studies

Silhouette
Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with with resectable High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC). The investigational drug used in this study is Pembrolizumab. The purposes of this study are to: determine how well pembrolizumab keeps the cancer from coming back or spreading as compared to placebo, determine if giving pembrolizumab after surgery and radiation helps patients live longer, and to test the safety of the study drug and see how patients' bodies handle it. Participants can expect to be in this study for about 8 years. This includes the time that participants will be on study drug and in follow up to see if the cancer has come back or spread.

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

Association of Connectivity Dysregulation with Image Disturbance in Head and Neck Cancer Survivors Save

Date Added
May 18th, 2019
PRO Number
Pro00086189
Researcher
Evan Graboyes

List of Studies

Silhouette
Keywords
Cancer/Head & Neck
Summary

The purpose of this study is to evaluate the processes within the brain that can affect how head and neck cancer patients think and feel about how they look and feel after treatment. Participation in this study involves completing some questionnaires and undergoing one fMRI scan, which typically lasts one hour. It is hoped that the information gained from the study will help improve care for patients with head and neck cancer.

Institution
MUSC
Recruitment Contact
Courtney Marsh
(843) 792-1176
marshch@musc.edu

A Randomized, Phase II Study of Ficlatuzumab with or without Cetuximab in Patients with Cetuximab-Resistant, Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Save

Date Added
March 12th, 2019
PRO Number
Pro00085004
Researcher
John Kaczmar

List of Studies

Silhouette
Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with Head and Neck Squamous Cell Carcinoma (HNSCC). The investigational drug used in this study is Ficlatuzumab. The main goals of this research study is to study the safety and effectiveness of Ficlatuzumab with or without Cetuximab, to determine which strategy will be more effective, as well as to learn the potential side effects of Ficlatuzumab alone or in combination with Cetuximab. It is unknown exactly how long participants can expect to be in the study. Subjects will receive treatment until the drug is no longer effective on their cancer.

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

Single-arm, Phase II Study Evaluating the Clinical Impact of Navigation on Delays and Racial Disparities Starting Postoperative Radiation Therapy for Adults with Locally Advanced Head and Neck Cancer: The NDURE Study Save

Date Added
January 25th, 2019
PRO Number
Pro00077402
Researcher
Evan Graboyes

List of Studies

Silhouette
Keywords
Cancer/Head & Neck
Summary

The purpose of this study is to evaluate whether a new patient navigation intervention can decrease delays starting radiation therapy after surgery for white and African-American head and neck cancer patients. Patients who have surgery and radiation for certain types of head and neck cancer are eligible for this study.
The study is sponsored by the Medical University of South Carolina and Hollings Cancer Center. The investigator in charge of this study is Evan Graboyes, MD.
The study is being done at one site: the Medical University of
South Carolina.
Approximately 45 subjects will take part at MUSC.

Institution
MUSC
Recruitment Contact
Courtney Marsh
(843) 792-0719
marshch@musc.edu

Transdisciplinary Oral/Oropharyngeal Cancer Research & Care in Head and Neck Cancer (TORCH): A Prospective Non-Randomized Study by the Head and Neck Oncology Group (HNOG) at the Medical University of South Carolina (MUSC) Save

Date Added
October 16th, 2018
PRO Number
Pro00079274
Researcher
Terrence Day

List of Studies


Profiles_link
Keywords
Cancer/Head & Neck
Summary

The purpose of this research study is to see if it is possible to collect tissue, saliva and blood samples from patients who are having surgery and send those samples to different labs across MUSC. The researchers in these labs will collect tissue, blood and saliva samples before surgery and during surgery to see if there are any changes in the samples. They will compare the changes in the samples to the clinical outcomes.

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

Knowledge and Delays in Diagnosis of Oropharyngeal Neoplasms Save

Date Added
June 19th, 2018
PRO Number
Pro00078856
Researcher
Amanda Barrett

List of Studies

Keywords
Cancer, Cancer/Head & Neck
Summary

The objective of this study is to determine potential factors that contribute to late-stage diagnosis and treatment of HPV-positive and HPV-negative oropharyngeal tumors. We have developed a voluntary survey that will be given to patients treated at the MUSC Head and Neck Tumor Center. The survey consists of subsections that identify general HPV knowledge, timeline to diagnosis and treatment, educational background, and sociodemographic characteristics. The participating patients will be given the Short Test of Functional Health Literacy (S-TOFHLA) with the survey. The survey and health literacy data will be used to assess correlations between these factors and the patients stage of cancer at diagnosis. This study will also compare a chart review of prospective patients with retrospective chart review of former oropharyngeal cancer patients. The chart review will include data such as: stage of cancer at diagnosis, treatment, sequence of intervention for diagnosis and treatment, type of biopsy, and types of doctors involved in diagnosis and treatment.

Institution
MUSC
Recruitment Contact
Amanda Barrett
(843) 446-2234
barretam@musc.edu

Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Locoregionally Advanced Head and Neck Cancer with a Contraindication to Cisplatin Save

Date Added
May 18th, 2018
PRO Number
Pro00077581
Researcher
Anand Sharma

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Head & Neck, Stage II, Stage III
Summary

This study is for patients that have been diagnosed with stage III-IVB Head and Neck cancer. The investigational drug in this study is MEDI4736 (Durvalumab). The purpose of the safety lead-in portion of the study is to determine whether adding the study drug MEDI4736 to radiation is safe in patients with head and neck cancer who cannot take the drug cisplatin. The purpose of the phase II/III portion is to compare any good and bad effects of usual radiation plus the study treatment, MEDI4736 (durvalumab), to the usual therapy of radiation plus cetuximab in patients with head and neck cancer who cannot take the drug cisplatin. Participants in the safety lead-in portion can expect to be in this study for approximately 2.5 years. Participants in the Phase II/III portion can expect to be in the study for up to 32 weeks, and then followed by their study doctor to monitor for side effects every year.

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

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