Photon/Proton Radiation Therapy for Oropharyngeal Cancers (OP01)
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|ClinicalTrials.gov Identifier: NCT00797446|
Recruitment Status : Terminated (Slow enrollment, feasibility issues)
First Posted : November 25, 2008
Last Update Posted : February 7, 2017
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|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Oropharyngeal Cancers|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Photon/Proton Radiation Therapy
Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.
- Collect and analyze morbidity outcomes: incidence of xerostomia [ Time Frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months ]
- Collect and analyze tumor control outcomes. [ Time Frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Biopsy-proven squamous cell carcinoma of oropharynx (tonsillar pillars, tonsillar fossa, soft palate, base of tongue).
- Stage I (T1N0)
- Stage II (T2N0)
- Favorable Stage III (T1N1/T2N1) and selected stage IV (T1-T2 early N2b)2 or less lymph node and 2 or less cm diameter lymph node
- Unfavorable stage III and selected stage IV (any T, N2c/N3)
- Surgery of the primary tumor/lymph nodes is limited to incisional/excisional biopsies.
- Will receive treatment with proton radiation.
- Evidence of distant metastasis.
- Previous irradiation for head and neck cancer.
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): NCT00797446
|United States, Florida|
|University of Florida Proton Therapy Institute|
|Jacksonville, Florida, United States, 32206|
|Principal Investigator:||Roi Dagan, MD, MS||University of Florida Proton Therapy Institute|
|Responsible Party:||University of Florida|
|Other Study ID Numbers:||
|First Posted:||November 25, 2008 Key Record Dates|
|Last Update Posted:||February 7, 2017|
|Last Verified:||February 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
Head and Neck Neoplasms
Neoplasms by Site