Optimized Intensity Modulated Irradiation for Head and Neck Cancer
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|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||Phase|
|Head and Neck Cancer||Radiation: IMRT Drug: Paclitaxel Drug: Carboplatin Drug: Cisplatin Drug: 5-Fluorouracil||Not Applicable|
|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|
|Actual Primary Completion Date :||June 2010|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|