Radiosensitization With Celecoxib and Chemoradiation for Head and Neck Cancer (RAD0201)
This study has been completed.
University of Alabama at Birmingham
Information provided by (Responsible Party):
Sharon Spencer, MD,, University of Alabama at Birmingham
First received: December 20, 2007
Last updated: March 13, 2013
Last verified: March 2013
Results First Received: May 30, 2012
|Study Design:||Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment|
Radiation: Radiation Therapy
|Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations|
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|Significant events and approaches for the overall study following participant enrollment, but prior to group assignment|
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|Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy||Patients with locally advanced head and neck cancer will be treated with weekly carboplatin, paclitaxel, and concurrent radiotherapy. Radiotherapy will be delivered at 1.8 Gy every day, to a maximum dose of 70.2 Gy. Carboplatin will be dosed at AUC=2.0, while paclitaxel will be dosed at 30mg/m2. Celecoxib will be delivered at 400mg twice daily, starting 1 week prior to the onset of radiotherapy to establish constant blood levels.|
Participant Flow: Overall Study
|Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy|
|Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.|
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|Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy||No text entered.|
|Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy|
Number of Participants
|Between 18 and 65 years||29|
Mean ± Standard Deviation
|53.83 ± 8.06|
Region of Enrollment
|1. Primary:||Toxicity of Celecoxib With Concurrent Weekly Chemotherapy and Radiotherapy in the Treatment of Locally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck. [ Time Frame: 2 years from radiation therapy ]|
|2. Primary:||Response as Evaluated by Recurrence of Diseases [ Time Frame: 2 years from end of treatment (Radiation therapy) ]|
Limitations and Caveats
|Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data|
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Results Point of Contact:
|Principal Investigators are NOT employed by the organization sponsoring the study.|
|There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.|
Results Point of Contact:
Name/Title: Dr. Sharon Spencer Professor of Radiation Oncology
Organization: UAB Hospital
Organization: UAB Hospital
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|Responsible Party:||Sharon Spencer, MD,, University of Alabama at Birmingham|
|ClinicalTrials.gov Identifier:||NCT00581971 History of Changes|
|Other Study ID Numbers:||F020703003, Link No: 000276825|
|Study First Received:||December 20, 2007|
|Results First Received:||May 30, 2012|
|Last Updated:||March 13, 2013|
|Health Authority:||United States: Institutional Review Board