Study of Unilateral Neck Irradiation in Patients With SCC of the Head and Neck (Unilateral)
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|ClinicalTrials.gov Identifier: NCT00206752|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : March 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma of the Head and Neck||Radiation: Radiation therapy Radiation: definitive external beam radiation in the ipsilateral neck||Not Applicable|
Patients will be treated with definitive external beam radiation plus/minus chemotherapy plus/minus neck dissection in the ipsilateral neck (post radiation). The primary site will be treated with definitive radiation therapy, or definitive surgery plus post-operative radiation therapy. Primary endpoints are loco-regional control, as well as quality of life, xerostomia, mucositis, and neck fibrosis.
Salivary evaluations shall be performed prior to the initiation of radiation therapy, during the second week of EBRT, and at the completion of radiation. Evaluations will also be conducted at 3, 6, and 12 months after the completion of EBRT.
Oral mucositis will be assessed prior to the initiation of EBRT and weekly during EBRT. Evaluations will also be conducted at 3 and 6 months after the completion of EBRT. Two standardized mucositis scales will be used: the RTOG scale and the WHO scale.
Clinical response will be evaluated by physical exam and PET/CT. PET/CT scans will be done at 3, 6, 12, 18, and 24 months, and then when clinically indicated during follow-up.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Prospective Evaluation of Unilateral/Ipsilateral Neck Irradiation in Selected Patients With Squamous Cell Carcinoma of the Head and Neck Who Are Managed by Radiation Therapy|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
Experimental: unilateral radiation therapy
definitive external beam radiation in the ipsilateral neck.
Radiation: Radiation therapy
definitive external beam radiation in the ipsilateral neck.Radiation: definitive external beam radiation in the ipsilateral neck
definitive external beam radiation in the ipsilateral neck
- FACT (head and neck);Xerostomia related Quality of Life Questionnaire [ Time Frame: September 2010 ]
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): NCT00206752
|United States, New York|
|Beth Israel Medical Center|
|New York, New York, United States, 10003|
|Principal Investigator:||Kenneth Hu, MD||Department of Radiation Oncology at Beth Israel Medical Center|