Optimized Intensity Modulated Irradiation for Head and Neck Cancer
|ClinicalTrials.gov Identifier: NCT00580983|
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : November 14, 2014
Last Update Posted : September 7, 2016
|Condition or disease||Intervention/treatment|
|Head and Neck Cancer||Radiation: IMRT Drug: Paclitaxel Drug: Carboplatin Drug: Cisplatin Drug: 5-Fluorouracil|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimized Intensity Modulated Irradiation for Head and Neck Cancer|
|Study Start Date :||August 2003|
|Primary Completion Date :||June 2010|
|Study Completion Date :||June 2010|
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|
- Percentage of Participants With Grade 0-1 Observer-rated Dysphagia [ Time Frame: 12 months ]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.
- The Mean Esophageal Radiotherapy Dose in Patients With Strictures and Without Strictures [ Time Frame: 5 years ]To assess the relationships between the mean radiotherapy dose delivered and objectively measured dysphagia.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580983
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109-5010|
|Principal Investigator:||Avraham Eisbruch, M.D.||University of Michigan Hospital|