Intensity-Modulated Radiotherapy for Recurrent Head and Neck Cancer
To demonstrate safety and efficacy of intensity-modulated radiotherapy (IMRT) for treatment of previously irradiated recurrent head and neck cancer.
Specific Aims: Identify acute and late toxicities, response rates, locoregional control, disease free survival, and overall survival with IMRT. Also, tumor response, the amount of tumor shrinkage or reduction, will be analyzed.
Rationale: Recurrent head and neck cancer is regarded as having limited treatment modalities since salvage surgery can only be accomplished on limited subgroups of patients. Chemotherapy has not shown clear clinical benefits and has significant toxicity. Re-irradiation has been used as a treatment modality. However, the re-irradiation dose is limited by significant toxicity that occurs with the cumulative dose of radiation. The use of IMRT can give a high dose to the recurrent tumor while limiting the dose to critical structures in the vicinity of the reirradiated volume thereby limiting toxicity and treating the recurrence to an adequate dose.
The number of subjects was determined from 2 stage design with a historical control group as comparison, and these numbers of subjects were found to be 40.
It is assumed that this treatment regimen will not be of further interest if the true response rate is less than 32.6% (Po0.326). It is also assumed that a true response rate of 53% or more (P10.53) would be of considerable interest in the treatment of recurrent head and neck cancer. The type I error (the probability of rejecting the hypothesis that the proportion responding to the treatment is less than or equal to Po when this hypothesis is actually true) is 0.05.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Protocol of Intensity-Modulated Radiotherapy for Treatment of Previously Irradiated Recurrent Head and Neck Cancer|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257335
|Principal Investigator:||Nilam Ramshinghani, MD||Chao Family Comprehensive Cancer Center|