Optimized Intensity Modulated Irradiation for Head and Neck Cancer
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|
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|