Clinically relevant cutoff points and severity ranges for the IMAGE-HN as a novel diagnostic strategy for head and neck cancer-related body image disturbance

Date Added
October 24th, 2020
PRO Number
Pro00103120
Researcher
David Macias

List of Studies

Keywords
Anxiety, Cancer/Head & Neck, Depression
Summary

In this study, patients will complete questionnaires to help us determine clinically relevant scores for a new patient-reported measure of body image distress following HNC treatment. A select group of patients will also undergo in-depth discussions to help us determine scores on the patient report measure that correlate with mild, moderate, and severe levels of image distress.

Institution
MUSC
Recruitment Contact
David Macias
8438346153
maciasd@musc.edu

Implementation and Effectiveness Trial of HN-STAR

Date Added
October 12th, 2020
PRO Number
Pro00104287
Researcher
Evan Graboyes

List of Studies


Keywords
Cancer, Cancer/Head & Neck
Summary

This study is for patients that have been diagnosed with head and neck cancer. The purpose of this study is to examine whether HN-STAR can help healthcare providers care for survivors of head and neck cancer.

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

A Randomized, Double-blind, Adaptive, Phase II/III Study of GSK3359609 or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1 Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Date Added
April 28th, 2020
PRO Number
Pro00096818
Researcher
John Kaczmar

List of Studies


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

This study is for patients that have been diagnosed with PD-L1 Positive Head and Neck Squamous Cell Carcinoma (HNSCC). Specifically, for people with this type of cancer that cannot be treated with surgery or radiation treatment and has not been treated for cancer that spread to sites distant from the head and neck region (metastatic) or for cancer that returned or got worse after being treated (recurrent).The investigational drug (not approved by the FDA) in this study is GSK3359609. The purpose of this research study is to find out if GSK3359609 combined with pembrolizumab works better than the single drug pembrolizumab. Participants can expect to receive treatment for about 3 years and be in follow-up for the rest of their life.

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects with Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed after Prior VEGFR-Targeted Therapy

Date Added
December 9th, 2019
PRO Number
Pro00091697
Researcher
Paul O'Brien

List of Studies


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

This study is for patients that have been diagnosed with differentiated thyroid cancer (DTC). The investigational drug used in this study is cabozantinib. The purpose of this study is to evaluate the effect of cabozantinib compared with a placebo in treating patients whose disease has progressed after receiving prior treatment with drugs that inhibit growth of tumor blood vessel (VEGFR-targeted therapy) for their thyroid cancer. Participants can expect to be on this study for about a year including 9 months of treatment, a follow-up visit 4 weeks after treatment and 3 months of follow up.

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

A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients With Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer

Date Added
November 13th, 2019
PRO Number
Pro00093609
Researcher
Anand Sharma

List of Studies


Keywords
Cancer/Head & Neck
Summary

This study is for patients with low-risk, Human Papillomavirus (HPV) positive oropharyngeal cancer. The first part of the study is to determine if a reduced dose of radiation along with chchemotherapy or immunotherapy result in the same length of time without the cancer getting worse as the usual approach. The second part of this study is being done to also see if quality of life with a reduced dose of radiation with chemotherapy or immunotherapy than the usual approach.

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

A Single-Site, Parallel-Group, Randomized-Controlled Pilot Trial Comparing BRIGHT with Active Control in Reducing Body Image Disturbance Among Head and Neck Cancer Survivors (BRIGHT 2.0)

Date Added
November 5th, 2019
PRO Number
Pro00085204
Researcher
Evan Graboyes

List of Studies


Keywords
Cancer/Head & Neck
Summary

Head and neck cancer arises in cosmetically and functionally critical areas of the face. As a result of head and neck cancer and its treatment, head and neck cancer survivors face significant issues related to disfigurement, difficulty swallowing, and challenges speaking. Unfortunately, we do not have effective ways to treat body image concerns in head and neck cancer survivors. Therefore we developed BRIGHT (Building a Renewed ImaGe after Head & neck cancer Treatment), a new telemedicine intervention for head and neck cancer survivors with body image concerns. The purpose of this study is to evaluate the effectiveness of BRIGHT as a new treatment strategy for head and neck cancer survivors with body image concerns.

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

A Phase 2 Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Adults with Head and Neck Cancer

Date Added
September 24th, 2019
PRO Number
Pro00091445
Researcher
John Kaczmar

List of Studies


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

This study is for patients that have been diagnosed with head and neck squamous cell cancer (HNSCC). The investigational drug in this study is ADU-S100. The purpose of this study is to find out how ADU-S100 and pembrolizumab (also called KEYTRUDA®) interact with the immune system to potentially treat cancer and to make sure the drugs are safe to use together. Participants can expect to recieve treatment for up to two years. This would include 2 doses in a3-week cycle for up to 35 cycles. Participants can expect follow-up to continue every eight weeks until completion of the required safety reporting periods, death, withdrawal of consent, loss to follow-up, or close of study by the Sponsor.

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

A Phase II/III Randomized Study of Maintenance Nivolumab Versus Observation in Patients With Locally Advanced, Intermediate Risk HPV Positive OPCA

Date Added
September 17th, 2019
PRO Number
Pro00092534
Researcher
John Kaczmar

List of Studies


Keywords
Cancer/Head & Neck
Summary

This study is for patients with HPV positive oropharynx cancer. The purpose is to determine if maintenance nivolumab following definitive therapy with radiation and chemotherapy (cisplatin) result in significat improvement in overall survival (OS) (time being alive) and progression-free survival (PFS) (time being alive without cancer).

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

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)

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

List of Studies


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

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

List of Studies


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



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