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Oral Cancer clinical trials

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NCT ID: NCT01445405 Completed - Clinical trials for Head and Neck Cancer

Radiation Therapy and Bortezomib and Cetuximab With or Without Cisplatin to Treat Head and Neck Cancer

Start date: February 5, 2008
Phase: Phase 1
Study type: Interventional

Background: Bortezomib acts on molecules in head and neck cancer cells that are important for the cells growth and survival. The drug may help make the cancer more sensitive to radiation and other chemotherapy drugs. Cetuximab is a monoclonal antibody that has increased the effectiveness of radiation treatment in patients with head and neck cancer in clinical trials. Cisplatin has shrunk head and neck cancers and improved treatment response and survival when combined with radiation treatment. Objectives: To determine the highest safe dose of bortezomib when combined with cetuximab without or with cisplatin and with radiation in patients with advanced head and neck cancer. To examine the benefits and side effects of these drug combinations with radiation in patients with advanced head and neck cancer. Eligibility: Patients 18 years of age and older with advanced Stage IV head and neck cancer who have not previously had neck radiation. Design: Patients will be assigned sequentially to one of two treatment groups: Group A receives bortezomib and cetuximab beginning the week before, and for the duration of, radiation therapy; Group B receives bortezomib, cetuximab and cisplatin beginning the week before, and for the duration of, radiation therapy. - Cetuximab is given as a 2-hour infusion through a vein (intravenously, IV) for the first dose and then over 1 hour for subsequent weekly doses. - Bortezomib is given as an injection into a vein over about 5 seconds, twice a week for 2 weeks, followed by a 1-week rest for a total of three 3-week treatment cycles during radiation. - Cisplatin is given in once a week as a 1-hour IV infusion - Radiation therapy is given 5 days a week for 7 to 8 weeks. Post-treatment follow-up: - Until 2 weeks after treatment ends, patients are followed once a week including a physical examination, review of treatment side effects, and blood tests. - For 2 months after treatment ends, patients may need to return to the hospital for medical evaluation and supportive care, depending on their condition. - 8-weeks after treatment ends, patients return for evaluation with a history and physical examination; blood tests; ear, nose and throat evaluation and endoscopy; CT or MRI scan, or both, of the neck and chest; and, if indicated, a PET scan....

NCT ID: NCT01440270 Completed - Oral Cancer Clinical Trials

Neo-adjuvant Erbitux-based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer

Start date: August 2011
Phase: Phase 2
Study type: Interventional

Epidermal growth factor receptor(EGFR) is a potential target for new anticancer therapy in head and neck squamous cell carcinoma, because blocking the EGFR by a monoclonal antibody results in inhibition of the stimulation of the receptor, therefore, in inhibition of cell proliferation, enhanced apoptosis, and reduced angiogenesis, invasiveness and metastases. The study hypothesis is that neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy for locally advanced oral/oropharyngeal cancer could benefit the patients on prognosis. The endpoints of this study are the pathological complete response after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy, the survival rate, and the safety.

NCT ID: NCT01434394 Completed - Oral Cancer Clinical Trials

Neoadjuvant Erbitux Based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer

EAGLE
Start date: August 2011
Phase: Phase 2/Phase 3
Study type: Interventional

EGFR is a potential target for new anticancer therapy in head and neck squamous cell carcinoma, because blocking the EGFR by a monoclonal antibody results in inhibition of the stimulation of the receptor, therefore, in inhibition of cell proliferation, enhanced apoptosis, and reduced angiogenesis, invasiveness and metastases. The study hypothesis is that neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy for locally advanced oral/oropharyngeal cancer could benefit the patients on prognosis. The endpoints of this study are the pathological complete response after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy, the survival rate, and the safety.

NCT ID: NCT01424358 Completed - Oral Cancer Clinical Trials

Web-based Education on Oral Cancer for Primary Care Physicians in Ohio

Start date: July 2011
Phase: N/A
Study type: Interventional

Objective: The experimental design is a one-site, randomized experimental web-based educational feasibility intervention trial, with approximately 50% primary care physicians (PCPs) in the intervention group and approximately 50% PCPs on the control group, giving a total of 159 participants. All 159 participants have willingly provided their e-mail addresses, as part of a survey they previously completed entitled, "Survey of Health Professionals on Oral Cancer in Ohio- Intervention to Prevent Delayed Diagnosis of Oral Cancer."

NCT ID: NCT01418118 Completed - Clinical trials for Head and Neck Cancer

Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery

Free4Flow
Start date: October 2008
Phase: Phase 4
Study type: Interventional

Following surgery to remove tumours of the head and neck, patients undergo reconstruction with free flaps - tissue that is taken from elsewhere in the body and given a new blood supply by attaching it to vessels in the neck. Following this type of surgery, patients often need medication to maintain their blood pressure in the intensive care unit. The effect of these drugs on the transplanted tissues is unknown. This study investigates the effects of four commonly used drugs on free flap perfusion.

NCT ID: NCT01351532 Completed - Oral Cancer Clinical Trials

Behavior Change on Oral Cancer Patients After a Localized Behavior Change Model Intervention

Start date: April 2011
Phase: N/A
Study type: Interventional

The purpose of this research is to apply this smoking cessation program on oral cancer patients, and to analyze the effectiveness of it.

NCT ID: NCT01136265 Active, not recruiting - Oral Cancer Clinical Trials

PET/CT and Sentinel Node in Oral Cancer

PETNode
Start date: June 2010
Phase: N/A
Study type: Observational

In this study, the investigators want to pre-operatively scan patients who do not have any clinically suspicion of metastases with an 18F-FDG-PET/CT whole body scan , where after they go to lymphoscintigraphy incl. SPECT/CT and sentinel node biopsy. Material from the oral cancer and, after permission of each patient, also normal oral tissue will be analyzed molecular-biologically. Also a blood sample will be analyzed for molecular tumor markers. The investigators want to see if PET/CT is able to detect any signs of sub-clinically metastases. Besides, the investigators want to fusion PET/CT with SPECT/CT data from the lymphoscintigraphy study and improve our PET/CT scanning with a dual-time PET scan of the head-and-neck region.

NCT ID: NCT01039298 Recruiting - Oral Cancer Clinical Trials

Efficacy of Optically-guided Surgery in the Management of Early-staged Oral Cancer - COOLS TRIAL

Start date: January 2013
Phase: Phase 3
Study type: Interventional

Oral squamous cell carcinoma (SCC) is a global disease responsible for ~300,000 new cancer cases each year. Local recurrence (~30% of cases) and formation of second primary malignancy are common.2, 3 Cosmetic and/or functional compromise associated with treatment of disease stage is often significant. These statistics underscore the urgent need to develop a better approach in order to control this deadly disease. It is becoming increasingly apparent that oral cancers develop within wide fields of diseased tissue characterized by genetically altered cells that are widespread across the oral cavity and present in clinically and histologically normal oral mucosa. Complete removal of these lesions is difficult because high-risk changes frequently go beyond clinically visible tumor. In recognition of this, current 'best practice' is to remove SCC with a significant width (usually 10 mm) of surrounding normal-looking oral mucosa. However, since occult disease varies in size such approach often results in over-cutting (causing severe cosmetic and functional morbidity) or under removal of disease tissue, as evidenced by frequent positive surgical margins and high local and regional recurrence - a failure of the 'best practice. There is a wealth of literature that supports the use of tissue autofluorescence in the screening and diagnosis of precancers in the lung, uterine cervix, skin and oral cavity. This approach is already in clinical use in the lung and the mechanism of action of tissue autofluorescence has been well described in the cervix. Changes in fluorescence reflect a complex interplay of alterations to fluorophores in the tissue and structural changes in tissue morphology, each associated with progression of the disease. As one of the internationally leading teams in applying tissue fluorescence technology, we have shown that direct fluorescence visualization (FV) tools can identify clinically visible or occult premalignant and malignant lesions that are associated with lesions at risk, with high-grade histology and high-risk molecular change. In a recently small scaled, retrospective study, we have shown that FV helped surgeons in the operating room to determine the extent of the high-risk FV field surrounding the cancer and resulted in remarkably lower 2-year recurrence rates (0% for FV-guided vs. 25% for those without FV-guided approach). There is need to design a larger scale prospective, randomized controlled (Phase III) trial to gather strong evidence in proving the efficacy of the surgery approach using this adjunct tool. To establish the evidence supporting the change in clinical practice using FV-guided surgery. There are 3 objectives. 2.1. Objective 1 (Clinical evidence): To assess the effect of FV-guided surgery on the recurrence-free survival of histologically confirmed disease within the context of a randomized controlled trial (efficacy). Hypothesis: FV-guided surgery will increase the recurrence-free survival. 2.2. Objective 2 (Quality of Life evidence): To establish the cost per recurrence prevented for this approach and assess quality of life issues. Hypothesis: FV-guided surgery can be delivered in a cost effective manner and improve the quality of life of patients 2.3 Objective 3 (Scientific/Molecular evidence): To assess the presence of previously validated molecular markers (microsatellite analysis, LOH) and histological change (quantitative pathology) in surgical margins in a nested case-control study involving a tumor bank created within this project. Hypothesis: FV-guided surgery will spare normal tissue at the same time improving capture of high-risk tissue.

NCT ID: NCT01039272 Completed - Oral Cancer Clinical Trials

Epstein-Barr Detection in Oral Cancer

Start date: March 2008
Phase: N/A
Study type: Observational

The aim of this study is to analyze oral squamous cell carcinoma and healthy oral mucosa for the possible presence of Epstein-Barr virus (EBV).

NCT ID: NCT00964977 Completed - Oral Cancer Clinical Trials

Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis.

Start date: October 2009
Phase: Phase 3
Study type: Interventional

Radiotherapy with or without adjuvant chemotherapy represents an important column of modern therapy in advanced squamous cell originated tumours of the head and neck. However to date no studies are available which study the effectiveness of radiotherapy in patients with resected small tumours (T1, T2) and concomitant ipsilateral metastasis of a single lymph node (pN1) for general treatment recommendation. The present study is designed as non-blinded, prospective, multicenter randomized controlled trial (RCT) for comparison of overall-survival as primary clinical target in patients receiving radiation therapy vs. patients without adjuvant radiation following curative intended surgery. Aim of the study is to enroll 560 adult males and females for 1:1 randomization to one of the two treatment arms (radiation/non-radiation. Secondary clinical endpoints are as follows: Incidence and time to tumor relapse (locoregional relapse, lymph node involvement and metastatic spread), Quality of life as reported by EORTC (QLQ-C30 with H&N 35 module) and time from operation to orofacial rehabilitation.