Optimized Intensity Modulated Irradiation for Head and Neck Cancer
The purpose of this study is to test whether the use of advanced radiation therapy delivery techniques can spare a patient's normal tissue, including salivary glands, from radiation. This study is being done to try to reduce radiation side effects, especially mouth dryness, which happens with standard radiation methods. In order to reduce these side effects, other normal tissues may receive a different radiation dose (sometimes more) than what would have been received using standard radiation therapy. A secondary goal of this study is to determine if the type of tumor a patient has can be controlled at least as well (or better) using this advanced radiation therapy delivery technique as it would be if the patient was treated with standard radiation therapy.
Head and Neck Cancer
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Optimized Intensity Modulated Irradiation for Head and Neck Cancer|
- Percentage of Participants With Grade 0-1 Observer-rated Dysphagia [ Time Frame: 12 months ] [ Designated as safety issue: No ]To objectively assess dysphagia and aspiration in patients receiving dysphagia/aspiration-sparing IMRT concurrent with chemotherapy, the percentage of participants with observer-rated dysphagia was calculated.
- To Assess the Relationships Between the Doses Delivered to the Dysphagia/Aspiration-related Structures and Objectively Measured Dysphagia and Aspiration. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2003|
|Estimated Study Completion Date:||May 2016|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.
Intensity-modulated Radiation Therapy (IMRT):
Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.
Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions.
|Radiation: IMRT Drug: Paclitaxel Drug: Carboplatin Drug: Cisplatin Drug: 5-Fluorouracil|
Studies show that a dose response relationship in the salivary glands exists and that it may be possible to improve significantly post-radiation xerostomia and quality of life if radiation techniques can be devised that would spare the salivary glands while adequately treating the targets. A new treatment modality (computer-optimized IMRT) facilitates increased sparing of noninvolved tissue, specifically the sparing of both parotid glands, and more conformal high-dose delivery to the bilateral neck targets in patients with head and neck cancer. This study will evaluate the benefits regarding xerostomia-specific and general QOL in patients receiving head and neck RT using this modality. Assessment of swallowing dysfunction and aspiration will be made using videofluoroscopy. In addition, this study will evaluate the pattern of local/regional tumor recurrence, to assess whether sparing both parotid glands may cause tumor recurrence in spared neck areas.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580983
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109-5010|
|Principal Investigator:||Avraham Eisbruch, M.D.||University of Michigan Hospital|