A Phase II Study to Evaluate Low-Dose Fractionated Radiotherapy (LDFRT)
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|ClinicalTrials.gov Identifier: NCT01820312|
Recruitment Status : Withdrawn (Due to no enrollment.)
First Posted : March 28, 2013
Last Update Posted : August 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma of the Head and Neck||Radiation: Low-Dose Fractionated Radiation Therapy/Paclitaxel||Phase 2|
This study will evaluate a combination therapy of paclitaxel and LDFRT. The paclitaxel will be commercially available drug product dispensed by a licensed pharmacist at UAMS. Radiotherapy will be delivered using either the TomoTherapy Treatment System (TomoTherapy, Inc.) or the Varian High Energy Linear Accelerator (Varian Medical Systems).
Subjects will undergo CT imaging (to include neck, chest, abdomen and pelvis) as part of the standard of care approximately 7 to 21 days prior to initiation of this therapy. Additional CT imaging will be done at UAMS approximately 3 months after completion of protocol therapy and every 3 months subsequently until progression or completion of the study whichever comes first. These CT imaging's will be obtained for recurrent tumor evaluation and determination of the presence or absence of distant metastasis, as part of the standard of care.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study to Evaluate Low-Dose Fractionated Radiotherapy (LDFRT) and Chemotherapy in Recurrent and Inoperable Squamous Cell Carcinoma (SCC) of the Head and Neck After Radiotherapy Failure|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
- Objective Response (OR) [ Time Frame: OR will be determined in each subject 3 months following therapy using CT imaging performed for clinical-care purposes ]Objective Response (OR). OR will be defined according to RECIST v1.1 criteria as either a complete or partial response. OR will be determined in each subject 3 months following therapy using CT imaging performed for clinical-care purposes.
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): NCT01820312
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rick, Arkansas, United States, 72205|
|Principal Investigator:||Jose Penagaricano, MD||University of Arkansas|