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Sponsored by: |
Alberta Cancer Board |
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Information provided by: | Alberta Cancer Board |
ClinicalTrials.gov Identifier: | NCT00137475 |
Radiotherapy is the primary treatment modality or an important adjunct treatment for many patients with H&N carcinoma. Local control is directly related to dose and to the technical accuracy with which the dose is delivered to the target volume. Traditional radiotherapy techniques result in significant doses being delivered to normal tissues adjacent to the target, including the spinal cord and salivary glands. This leaves the patient with significant acute and late normal tissue toxicity that impacts on both the ability to tolerate the actual treatment and on the patient's long-term quality of life. Recently, the investigators have used static conformal multisegmental intensity modulated radiotherapy (IMRT) for a comprehensive irradiation of head and neck cancer with dose sparing of uninvolved tissues. This has resulted in substantial preservation of major salivary gland function in many patients with primary sites in the oral pharynx, oral cavity, nasopharynx, and pyriform sinus. While the investigators' results to date have shown promising preservation of salivary flow, they do not know whether patients treated with IMRT have similar local control rates as those treated with standard radiotherapy. Some investigators have raised the concern that by giving a low radiation dose to areas adjacent to the target volume there is a risk of undertreating the disease. On the other hand, the IMRT delivered with this protocol (called "simultaneous integrated boost", or SIB) may improve local control rates by delivering the same biologically effective dose in a shorter overall time period. This is a phase I/II trial which seeks to establish the efficacy of IMRT for H&N cancer treatment, and to further investigate the relationship between radiation dose to the parotid glands, salivary flow, and quality of life.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Procedure: Intensity-Modulated Radiation Therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Feasibility/Efficacy Study Using Intensity-Modulated Radiation Therapy in Head and Neck (H&N) Cancer Patients to Permit Sparing of Parotid Gland Function |
Estimated Enrollment: | 120 |
Study Start Date: | February 2002 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rufus Scrimger, MD | 780-432-8517 | rufusscr@cancerboard.ab.ca |
Canada, Alberta | |
Cross Cancer Institute | Recruiting |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Contact: Clinical Researrch Unit 780-989-8152 clinical_trials_cci@cancerboard.ab.ca | |
Principal Investigator: Rufus Scrimger, MD |
Principal Investigator: | Rufus Scrimger, MD | Alberta Cancer Board |
Study ID Numbers: | NA-15-0006 |
Study First Received: | August 26, 2005 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00137475 History of Changes |
Health Authority: | Canada: Health Canada |
IMRT head and neck cancer parotid sparing |
Head and Neck Neoplasms |
Neoplasms Neoplasms by Site Head and Neck Neoplasms |