Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257335
Status:
WITHDRAWN
Last Update Posted:
2017-07-31
First Post:
2005-11-21
Brief Title:
Intensity-Modulated Radiotherapy for Recurrent Head and Neck Cancer
Sponsor:
Nilam Ramsinghani
Organization:
University of California Irvine
Study Overview
Official Title:
A Phase II Protocol of Intensity-Modulated Radiotherapy for Treatment of Previously Irradiated Recurrent Head and Neck Cancer
Status:
WITHDRAWN
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to no patient enrollment this study was withdrawnclosed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 326 Po0326 It is also assumed that a true response rate of 53 or more P1053 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 005
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 326 Po0326 It is also assumed that a true response rate of 53 or more P1053 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 005
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None