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| Sponsor: | University of California, Irvine |
|---|---|
| Information provided by: | University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00257335 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma of the Head and Neck |
Procedure: IMRT |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Protocol of Intensity-Modulated Radiotherapy for Treatment of Previously Irradiated Recurrent Head and Neck Cancer |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria
Contacts and Locations
More Information
| Study ID Numbers: | UCI 03-58 |
| Study First Received: | November 21, 2005 |
| Last Updated: | February 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00257335 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Carcinoma of the head and neck |
|
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Head and Neck Neoplasms |
Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Carcinoma |