Neoplasms

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Oropharyngeal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

All patients will receive concurrent cisplatin and radiation therapy with radiation dose de-escalation to clinically and radiologically uninvolved lymph nodes.

Standard dose cisplatin given concurrently with radiation therapy

Cisplatin injection

Gregory Biedermann, MD

Ken Baker, RN

This trial will explore giving standard dose chemotherapy and radiation therapy to sites of disease including all lymph nodes involved with HPV-positive oropharyngeal cancer, but administer lower doses of radiation therapy to the lymph nodes that are not known to be involved with cancer. By doing so, it is hypothesized that there will be equally good long term loco-regional and distant disease control but will reduced long term treatment side effects and improved quality of life in persons living well beyond their cancer treatment.

This is a trial of definitive chemotherapy and radiation therapy in human papilloma virus positive oropharyngeal cancers, in a population whose cancer is thought to be highly radio-sensitive. This is a population whose outcomes are already known to be very good with high rates of local and distant control of the disease. With the long term disease control and survival of patients with this disease, long term treatment toxicity and resulting reduction in quality of life poses new problems. This has lead to several studies to examine the role of radiation dose de-escalation through various strategies in attempt to reduce long term toxicity from treatment and yet achieve equivalent long term disease control.

This trial specifically hypothesizes that a lower dose of radiation therapy to the clinically and radiographically uninvolved lymph nodes will no detrimental effect on loco-regional control or overall survival and will improve the long-term side effect profile, particularly with regards to xerostomia and dysphagia. The goal of this study is therefore to determine whether a lower dose to the clinically and radiographically uninvolved lymph nodes can be done safely and with better long-term toxicity profile and better overall quality of life without compromising the expected outcomes of progression free survival.

All patients are treated with the same approach.

Testing Less Intensive Radiation With Chemotherapy to Treat Low-risk Patients With HPV-positive Oropharyngeal Cancer

Phase II Trial of Definitive Chemoradiation With Elective Nodal Irradiation Dose De-escalation for p16 Positive Squamous Cell Carcinoma of the Oropharynx "ENID"

Progression-free survival of 85% or more at measured a 2 years post treatment

To report the change in dysphagia using the M. D. Anderson Dysphagia Inventory (MDADI) scores. Scores are 0 (lowest functioning) to 100 (highest functioning).

European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire

To determine overall survival and progression-free survival

Incidence of Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher for mucositis, dysphagia, xerostomia and altered taste

University of Missouri-Columbia

Assistant Professor of Clinical Radiology / Radiation Oncologist

Nervous System Diseases

Symptoms and General Pathology

Trismus

Patients use the password-protected Project Prepare website on a computer, tablet, or phone over 10 weeks to view: videos of the swallowing and trismus exercises, tips and stories from former patients, what to expect each week of treatment, recipes and cooking demonstrations, how to take care of their teeth during treatment, strategies for stress relief, and strategies for dry mouth and nausea. This website is designed to reach underserved populations who do not have ready access to specialized preventive care.

Internet-Based Intervention

Quality-of-Life Assessment

Questionnaire Administration

Eileen H Shinn

Katrina M. Jensen

Eileen H. Shinn

This phase II trial studies how well a web-based program called Project Prepare works in helping patients with head and neck cancer adhere to swallowing and trismus exercises and coping strategies. Head and neck cancer patients who receive radiation therapy are at risk for permanent swallowing disorders and other side effects. Because of these potential problems, swallowing exercises and coping strategies are important parts of recovery. A web-based program designed to increase adherence to preventive exercises may help patients with head and neck cancer ameliorate the long-term effects of radiation therapy.

PRIMARY OBJECTIVE:

I. To determine the impact of a web-based adherence program (PREPARE) on self-reported swallowing function in head and neck cancer patients during radiation.

SECONDARY OBJECTIVE:

I. To determine community participant adherence to targeted swallowing and trismus exercises delivered by the PREPARE website video demonstrations.

EXPLORATORY OBJECTIVE:

I. To promote the long-term dissemination of the Dysphagia Prevention program through measurement of patient satisfaction and engagement metrics, training and continual feedback between the MD Anderson Cancer Center (MDACC) research site and community collaborative research sites.

OUTLINE:

Patients use the password-protected Project Prepare website on a computer, tablet, or phone over 10 weeks to view: videos of the swallowing and trismus exercises, tips and stories from former patients, what to expect each week of treatment, recipes and cooking demonstrations, how to take care of their teeth during treatment, strategies for stress relief, and strategies for dry mouth and nausea. This website is designed to reach underserved populations who do not have ready access to specialized preventive care.

After completion of study, patients are followed up at 6 months.

Web-Based Program in Helping Patients With Head and Neck Cancer Adhere to Swallowing Exercises and Coping Strategies

Mobile Delivery of a Coping and Adherence Program for Head and Neck Cancer Patients Being Treated in Community Care Settings

Assessed with the MD Anderson Dysphagia Inventory (MDADI). Will first test for changes in self-reported swallowing function outcome with the MDADI between baseline and follow-up using one-tailed paired t-tests. Correlations and multivariate analyses regressing self-reported adherence to exercises against self-reported swallowing function will be analyzed similarly and appropriately.

Piwik analytics will be used to record usage data regarding patient engagement with the website (e.g. whether the patient looked at the website that week, number of minutes and number of navigations and pages visited).

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Recurrence

Paclitaxel

Carboplatin

Pembrolizumab

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants in this group will receive pembrolizumab 200 mg through an intravenous (IV) needle inserted into the arm. Medications will be given on day 1 of each 21-day cycle for two cycles..

Participants in this group will receive 200 mg of pembrolizumab through an intravenous (IV) needle inserted into the arm plus chemotherapy with carboplatin (AUC 6) on day 1 and paclitaxel (200 mg) on day 1 of each 21-day cycle for two cycles.

A drug that binds to a protein called programmed cell death 1 (PD-1) to help immune cells kill cancer cells better. Pembrolizumab is used to treat many different types of cancer.

A chemotherapy drug used to treat cancer.

Ari Rosenberg, MD

Cancer Clinical Trials Intake

Ari Rosenberg

By doing this study, the research team would like to learn if using a blood test that measures the amount of tumor DNA in blood can help guide how to use chemotherapy combined with immunotherapy for individuals with head and neck cancer. Using this blood test, the research team hopes to learn if intermittent (occasional) chemotherapy added to immunotherapy will work better than immunotherapy alone. Participation in this research will last about two years.

By doing this study, the research team hopes to learn if using a blood test that measures the amount of tumor DNA in blood can help guide how to use chemotherapy combined with immunotherapy for individuals with head and neck cancer. Using this blood test, the research team hopes to learn if intermittent (occasional) chemotherapy added to immunotherapy will work better than immunotherapy alone. Participation in this research will last about two years.

The purpose of this research is to gather information on how well immunotherapy with intermittent chemotherapy guided by measurements of tumor DNA in blood will work and to learn about the safety and effectiveness of this new treatment strategy. All of the drugs used in this trial are approved by the US Food and Drug Administration (FDA); however, they are being combined in a new way based on changes in tumor DNA in the participant's blood which can only be done in a research study.

A Study of Pembrolizumab in Combination With Chemotherapy for Head and Neck Cancer

A Phase II Study of Pembrolizumab in Combination With Circulating Tumor DNA Response-Adaptive Pulsed Chemotherapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: The SINERGY Trial (Squamous Cell Carcinoma of Head and Neck Response-Guided Therapy)

Overall response rate with pembrolizumab in combination with circulating tumor DNA (ctDNA) chemotherapy among subjects with head and neck cancer. Response rate will be defined as the proportion of participants with a complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

The rate of adverse events (Grade 3 of higher) reported among participants who receive pembrolizumab + chemotherapy compared to the rate of adverse events (Grade 3 or higher) reported among participants who received pembrolizumab +chemotherapy in a previous related study called Keynote-48. Adverse events will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.

Progression Free Survival of pembrolizumab combination with circulating tumor DNA (ctDNA) response-adaptive pulsed chemotherapy among participants. Progression free survival will be defined as the time from date of first dose of study drug to date of documented progressive disease (PD) based on Response Evaluation Criteria in Solid Tumors version 1.1 ( RECIST v1.1 )or death, whichever occurs first.

The overall survival of pembrolizumab in combination with circulating tumor DNA (ctDNA) response-adaptive pulsed chemotherapy in participants with head and neck cancer. Overall survival will be defined as the time from the date of first dose of study drug to the date of death.

The duration of response (DoR) of pembrolizumab in combination with circulating tumor DNA (ctDNA) response-adaptive pulsed chemotherapy in participants with head and neck cancer. Duration of response will be defined as the time from date of first documented response to the date of documented progressive disease or death, based on Response Evaluation Criteria in Solid Tumors version 1.1 ( RECIST v1.1).

The rate of adverse events reported among participants who receive pembrolizumab in combination with chemotherapy as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.

Rate of adverse events leading to discontinuation or death among participants as assessed by Common Criteria Terminology for Adverse Events (CTCAE v. 5.0).

Proportion of participants who begin to receive a lower dose of study drugs (known as a "de-escalated" dose) based on decreases in circulating tumor DNA (ctDNA) from pembrolizumab and chemotherapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Testing Less Intensive Radiation With Chemotherapy to Treat Low-risk Patients With HPV-positive Oropharyngeal Cancer	NCT04444869	Cancer of the H... Oropharynx Canc... HPV Positive Or... Throat Carcinom...	Cisplatin injec...	18 Years -	University of Missouri-Columbia
Web-Based Program in Helping Patients With Head and Neck Cancer Adhere to Swallowing Exercises and Coping Strategies	NCT04003051	Throat Carcinom...	Internet-Based ... Quality-of-Life... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
A Study of Pembrolizumab in Combination With Chemotherapy for Head and Neck Cancer	NCT05420948	Head and Neck C... Head and Neck S... Head and Neck N... Head Cancer Throat Carcinom...	Pembrolizumab Carboplatin Paclitaxel	18 Years -	University of Chicago
A Study of Pembrolizumab in Combination With Chemotherapy for Head and Neck Cancer	NCT05420948	Head and Neck C... Head and Neck S... Head and Neck N... Head Cancer Throat Carcinom...	Pembrolizumab Carboplatin Paclitaxel	18 Years -	University of Chicago

Spots Global Cancer Trial Database for throat carcinoma