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Oropharyngeal Neoplasms clinical trials

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NCT ID: NCT04277858 Recruiting - Oropharynx Cancer Clinical Trials

Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Oropharyngeal Cancer.

NECTORS
Start date: August 14, 2018
Phase: Phase 2
Study type: Interventional

The objective of this trial is to study the efficacy of treatment of human papilloma virus (HPV) related oropharyngeal cancer with chemotherapy followed by Transoral Robotic Surgery (TORS) as definitive treatment. Current treatment of oropharyngeal cancer are chemo-radiotherapy. There is significant lifelong side effects associated with this approach related to tissue effects of radiotherapy. The side effects results in significant quality of life deterioration among the patients. Overall there is 20% failure rate with this treatment approach. The study hypothesis is that treatment with upfront (neoadjuvant) chemotherapy followed by transoral surgery and neck dissection is highly effective treatment allowing competitive cure rate compared to chemo-radiotherapy with less than 10% failure rate, while avoiding radiotherapy in majority of cases. It is also hypothesized that better functional and quality of life outcome maybe achieved with this approach.

NCT ID: NCT04266093 Enrolling by invitation - Clinical trials for Cervical Intraepithelial Neoplasia

Gene Therapy Follow up Protocol for Subjects Previously Enrolled in NCI Center for Immuno-Oncology Studies

Start date: May 8, 2020
Phase:
Study type: Observational

Background: Gene therapy is closely followed by the U.S. Food and Drug Administration (FDA). The FDA requires researchers to conduct long-term follow-up of people who have had the treatment. This study collects data on people who have had gene therapy and sends it to the FDA. The data does not include participants names. Objective: To contact current or past participants of gene therapy protocols at least once a year for up to 15 years to ensure they have not had any harmful side effects. Eligibility: People aged 18 and older who have had gene therapy in a National Cancer Institute study Design: Participants will give their address and telephone number. They will also give and the address and phone number of 1 or 2 other people who will know where they are. For the first year after gene therapy, participants will give blood samples 3 times (at 3, 6, and 12 months). For the next 4 years, they may have a physical exam and laboratory tests with a home physician. They will get a kit to mail in blood samples. Or they can visit the NIH Clinical Center. They will be asked if they have had any signs of neurological, autoimmune, or blood disorders, or any new cancers. For years 6 to 15, participants will be contacted yearly via phone or email and asked questions about their health. They may give blood samples. When the participant dies, if researchers think the death was caused by gene therapy, they will ask the participant s family to allow an autopsy. ...

NCT ID: NCT04251949 Completed - Oral Cancer Clinical Trials

Evaluation of the Photobiomodulation Using LED Lamp for Curative Treatment of Radio-induced Mucositis.

MuciLight
Start date: March 19, 2021
Phase: Phase 2
Study type: Interventional

This is a monocentric, prospective, non-comparative phase II study with minimal risks and constraints. The study will aim to assess the curative treatment of radio-induced mucositis by photobiomodulation using LED lamp.

NCT ID: NCT04189107 Completed - Surgery Clinical Trials

Postoperative Pain, Why Still in Hospital and DAOH Following TORS for SCCUP & OSAS

Start date: August 18, 2020
Phase: Phase 3
Study type: Interventional

This protocol investigates the effect of a high dose dexamethasone regimen in the treatment of postoperative pain following Transoral Robotic Surgery (TORS). The protocol consists of three substudies. 1. Randomized double-blinded clinical trial assigning half of the participants to a high-dose dexamethasone regimen while the other half will receive a low-dose dexamethasone dosage and placebo in the first postoperative period. 2. A investigation of "Why in hospital?" following TORS. From the first postoperative day until discharge reasons for continued hospitalization will be registered in order to identify clinical and organizational factors contributing to hospitalization 3. An assessment of "Days Alive and Out of Hospital" following TORS. From the day of surgery and the first 12 postoperative months all admissions to a hospital ward will be registered along with admission reasons. Any death during the first 12 months will be noted with a cause of death.

NCT ID: NCT04189003 Completed - Clinical trials for Oropharyngeal Cancer

Molecular Signatures of HPV+ ORL Cancers (OROPAP)

OROPAP
Start date: June 1, 2019
Phase:
Study type: Observational

The aim of this study is to identify HPV molecular signature in head and neck cancer to establish a new classification for positive human papillomavirus oropharyngeal tumor

NCT ID: NCT04178174 Recruiting - Clinical trials for Head and Neck Cancer

Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer

SHORT-OPC
Start date: February 23, 2020
Phase: Phase 2
Study type: Interventional

This is a randomized clinical trial comparing the outcomes of short-course chemoradiation consisting in stereotactic boost to the gross tumor and de-esclalated chemoradiation to the elective neck in human papilloma associated oropharynx cancer vs. the current standard 7-week course chemoradiation.

NCT ID: NCT04162873 Suspended - Clinical trials for Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer

Start date: November 27, 2019
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well celecoxib works through surgery and radiation therapy in treating patients with head and neck cancer that has spread to other places in the body (advanced). Celecoxib is Food and Drug Administration approved to treat arthritis, acute pain, and painful menstrual periods. Adding celecoxib to standard of care treatment may help to decrease the amount of time between surgery and radiation therapy.

NCT ID: NCT04140513 Withdrawn - Clinical trials for Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

Digital PET Scan for the Prediction of Outcomes in Patients With Locally Advanced Oropharyngeal Cancer

Start date: October 9, 2020
Phase: N/A
Study type: Interventional

This trial studies how well digital PET scan works in predicting outcomes in patients with oropharyngeal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). The development of digital detectors for PET is a technological improvement in medical imaging that could potentially impact many areas of clinical oncology, including staging, radiation planning accuracy, and the assessment of treatment response. Digital technology may improve PET imaging performance by providing better timing, energy and spatial resolution, higher count rate capabilities and linearity, increased contrast, and reduced noise. Utilizing digital PET scan, may work better in predicting outcomes and treatment response in patients with oropharyngeal cancer compared to conventional PET.

NCT ID: NCT04124198 Recruiting - Quality of Life Clinical Trials

Quality of Life After Primary TORS vs IMRT for Patients With Early-stage Oropharyngeal Squamous Cell Carcinoma

QoLATI
Start date: March 1, 2019
Phase: N/A
Study type: Interventional

Oropharyngeal squamous cell carcinoma (OPSCC) is now the most frequently diagnosed head and neck cancer in Denmark which is mainly due to the increase of Human Papillomavirus (HPV). Patients with HPV-positive OPSCC have a significantly higher survival rate compared to HPV-negative OPSCC. The traditional primary treatment modality in Denmark is Intensity Modulated Radiation Therapy (IMRT), and in advanced stages in combination with chemotherapy. Since 2009, Transoral Robotic Surgery (TORS) has enabled surgeons to perform minimally invasive surgery as an alternative to standard radiotherapy treatment which is considered the primary treatment for OPSCC in many countries. There is a lack of randomised trials comparing long-term functional outcomes after TORS or IMRT. Current data are mostly derived from retrospective studies with selection bias. However, several small retrospective studies have shown promising results when comparing the two treatment modalities in favour of TORS with regards to treatment related swallowing function and quality of life (QoL) without compromising survival outcomes. This study aims to evaluate the early and long-term functional outcomes following two treatment arms 1) TORS combined with neck dissection and 2) IMRT±concurrent chemotherapy with a special focus on swallowing-related QoL.

NCT ID: NCT04116047 Active, not recruiting - Clinical trials for Oropharyngeal Cancer

CompARE: Escalating Treatment of Intermediate and High-risk Oropharyngeal Cancer (OPC)

CompARE
Start date: July 2015
Phase: Phase 3
Study type: Interventional

CompARE is a multicentre, phase III open-label randomised controlled trial using an adaptive, Multi-Arm, Multi-Stage (MAMS) design.