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Head and Neck Neoplasms clinical trials

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NCT ID: NCT00656760 Completed - Clinical trials for Head and Neck Cancer

PET/CT: Role in Detecting Unknown Primary Head and Neck Cancer

Start date: July 2007
Phase: N/A
Study type: Interventional

Historically metastatic squamous cell carcinoma in a cervical lymph node from an occult primary malignancy of the head and neck was evaluated with panendoscopy and biopsies of high risk areas, such as the base of tongue, nasopharynx, and tonsils. This diagnostic protocol identifies the primary malignancy in about 50% of cases. In recent years, the availability of CT has slightly increased the detection rate to 65% when used as an adjunct to the traditional work-up. Studies using PET as an adjunct are conflicting with detection rates ranging up to 75%. Currently, no prospective study has analyzed the role of the PET-CT fusion in the work-up of an occult primary malignancy of the head and neck. This study will compare the detection rate of the traditional work-up to a new protocol involving a pre-operative diagnostic PET-CT.

NCT ID: NCT00656513 Completed - Clinical trials for Head and Neck Cancer

Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer

Start date: September 2008
Phase: Phase 2/Phase 3
Study type: Interventional

RATIONALE: Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) and pilocarpine may help to relieve chronic xerostomia (dry mouth). It is not yet known which remedy is more effective in treating chronic dry mouth caused by radiation therapy in patients with head and neck cancer. PURPOSE: This randomized phase II/III trial is studying ALTENS to see how well it works compared with pilocarpine in treating chronic dry mouth caused by radiation therapy in patients with head and neck cancer.

NCT ID: NCT00655005 Completed - Clinical trials for Head and Neck Cancer

Investigation of Pain and Symptom Burden in Patients With Newly Diagnosed Head and Neck Cancer

Start date: May 2007
Phase: N/A
Study type: Observational

RATIONALE: Collecting information by questionnaire about the quality of life of patients with head and neck cancer may help doctors learn more about the disease. PURPOSE: This clinical trial is testing a questionnaire for assessing pain control, head and neck symptoms, and general symptoms of illness, demographics, moods, alcohol and tobacco history, and quality of life related to cancer in patients with newly diagnosed head and neck cancer.

NCT ID: NCT00652613 Active, not recruiting - Clinical trials for Squamous Cell Carcinoma of the Head and Neck

Study of 3-Dimensional Conformal Radiotherapy (3D-CRT) Versus Intensity Modulated Radiotherapy (IMRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)

Start date: August 2005
Phase: Phase 2
Study type: Interventional

Head & Neck squamous cell carcinomas are the commonest cancers afflicting the developing countries. Traditionally surgery or radiotherapy alone in the early stages and surgery with postoperative radiotherapy in advanced stages have been the mainstay of treatment. Of late there has been a paradigm shift in the management of these cancers, particularly those of the oropharynx and laryngopharynx, where chemoradiation has been advocated as part of organ preservation protocol with good outcomes. Conventional radiotherapy involves the use of 2 or 3 field technique with or without compensators to encompass the volume at risk to radical doses of 66-70 Gy typically needed to sterilize gross disease. This strategy however is associated with considerable acute morbidity (mucositis, dysphagia, dermatitis) and debilitating late toxicity (xerostomia). Three dimensional conformal radiation therapy (3D-CRT) and intensity modulated radiation therapy (IMRT) have the potential to improve the dose distribution, with increased doses to the target volumes and reduced doses to surrounding normal structures, thereby improving the therapeutic ratio.

NCT ID: NCT00646659 Terminated - Clinical trials for Head and Neck Cancer

Cetuximab, Combination Chemotherapy, and Radiation Therapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Head and Neck Cancer That Cannot Be Removed By Surgery

Start date: February 2008
Phase: Phase 2
Study type: Interventional

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking blood flow to the tumor. Radiation therapy uses high energy x- rays to kill tumor cells. Cetuximab may also make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which regimen of radiation therapy, combination chemotherapy, and cetuximab and is most effective in treating patients with head and neck cancer. PURPOSE: This randomized phase II trial is comparing two different regimens of radiation therapy given together with combination chemotherapy and cetuximab to see how well they work in treating patients with newly diagnosed stage III or stage IV head and neck cancer that cannot be removed by surgery.

NCT ID: NCT00639769 Completed - Clinical trials for Head and Neck Cancer

Irinotecan and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Start date: February 2002
Phase: Phase 2
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: To determine if CPT-11 given together with cisplatin is effective in treating recurrent or metastatic head and neck cancer.

NCT ID: NCT00634777 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

Assessment of Regional Response With PET-FDG in Advanced Head and Neck Squamous Cell Carcinoma

pet
Start date: January 2007
Phase: N/A
Study type: Interventional

Patients with advanced head and neck squamous cell carcinoma (HNSCC) may benefit from organ-preservation treatment based on combination of chemotherapy and radiotherapy without compromising disease-free and overall survival. In patients with initially advanced regional disease, there is controversy about the place of routine planned lymph node neck dissection after chemoradiotherapy, especially in responding patients without clinically invaded residual lymph nodes. There is uncertainty about the lymph nodes status after chemoradiation because the structural imaging modalities (CT, MRI) lack sensitivity and specificity : small positive lymph nodes are not detected, and residual large lymph nodes can be sterilized ( " ghosts nodes " with no sign of viable tumor cells at histopathology). Despite the absence of evidence based on prospective study, in numerous institutions currently, head and neck surgeons are quite reluctant to operate on for neck dissection patients with a complete clinical and radiological response following chemoradiation. Metabolic imaging of tumors using PET and the glucose analog FDG has proven effective in head and neck SCC, especially after treatment to differentiate disease progression from radiation-induced inflammation.1 Several studies have shown that the metabolic response could predict the presence or absence of residual tumor cells in the primary tumor as well as the probability of relapse .2-4 Conflicting results have been reported on the use of PET to predict the pathological nodal status after chemoradiation, with negative predictive values ranging from 14 % to 100 %.5,6 Discrepancies observed might be due to the fact that PET was performed at variable time points after the end of radiotherapy. Ideally, PET should be performed as late as possible so that tumor regrowth can begin and become detectable, increasing the sensitivity of the procedure.

NCT ID: NCT00634595 Recruiting - Clinical trials for Nasopharyngeal Carcinoma

Trial of E10A in Head and Neck Cancer

Start date: March 2008
Phase: Phase 2
Study type: Interventional

Angiogenesis, the formation of new blood vessel from existing vessels, is essential for tumor growth and metastasis. Antiangiogenic therapies inhibit the growth of genetically stable endothelial cells, and most tumors should starve to death with little acquired resistance. Endostatin has been shown to block endothelial cell proliferation, survival, and migration. Antitumor activity of endostatin protein has been demonstrated in various murine and human tumors in animal model studies without any detectable toxicity. Endostatin gene therapy could directly express the highly bioactive protein in vivo by means of the mechanism of eukaryotic expression system as post-translational modification and folding, as well as overcoming the challenge of the long-term storage and the cumbersome daily administration of endostatin protein. E10A is a replication-deficient recombinant adenovirus containing a wild-type human endostatin transgene constructed from serotype 5 adenovirus (Ad5). Preclinical studies demonstrated that intratumoral injection of E10A provided significant tumor growth inhibition and sustained elevation of endostatin in blood and tumor tissue in hepatocellular carcinoma, nasopharyngeal carcinoma, and tongue cancer animal models. A Phase I clinical trial of E10A we conducted showed that repetitive intratumoral injection of E10A resulted in a small and sustained elevation of endostatin in blood and had a mild antitumor activities with very limited toxicity. The major toxicity was transient and manageable fever. A randomized Phase III trial in nonsmall-cell lung cancer showed endostatin improved response rate and time to tumor progression in combination to chemotherapy. Therefore, we designed a randomized phase II trial to explore the safety and effectiveness of E10A combined with chemotherapy in the treatment of patients with head and neck cancer.

NCT ID: NCT00629226 Completed - Clinical trials for Head and Neck Cancer

Bortezomib, Cetuximab, and Radiation Therapy With or Without Cisplatin in Treating Patients With Stage IV Head and Neck Cancer

Start date: October 2007
Phase: Phase 1
Study type: Interventional

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high energy x- rays to kill tumor cells. Bortezomib and cetuximab may make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with cetuximab, radiation therapy, and cisplatin may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with cetuximab and radiation therapy with or without cisplatin in treating patients with stage IV head and neck cancer.

NCT ID: NCT00627835 Withdrawn - Clinical trials for Locally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)

Dose Escalation Trial of Neoadjuvant Sorafenib and Concurrent Sorafenib, Cisplatin and Radiation in Locally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)

Start date: n/a
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and determine MTD (maximal tolerated doses) and recommended doses of neoadjuvant sorafenib (BAY 43-9006) and concurrent sorafenib, cisplatin and radiation in the locally advanced squamous cell carcinomas of the head and neck (SCCHN)patient population.