Prognostic Value of Circulating Tumor Cells in Patients With Locally Advanced and Metastatic/Recurrent Head and Neck Cancer
1. Histologically or cytopathologically proven head and neck squamous cell carcinoma
(HNSCC)
2. Disease status: locally advanced or recurrent/metastasized at initial presentation
3. Age >=20 years old
4. Could understand and signed the informed consents of this study
5. Enrolled patients were classified into three distinct subgroups:
1. Patients underwent curative surgery followed by adjuvant chemoradiotherapy (CRT)
because of some pathologic features such as positive margin, pathologic N2, and
extracapsular spread (ECS) of involved lymph nodes indicating early relapse
according to recommendation from National Comprehensive Cancer Network(NCCN)
guidelines;
2. Patients with advanced disease directly underwent definitive concurrent
chemoradiotherapy(CCRT);
3. Patients were to have palliative chemotherapy for existence of distant metastasis
or poor general condition for definitive CCRT.
6. Blood samples were collected within 7 days before the first dose of chemotherapy.
Observational [Patient Registry]
Observational Model: Cohort, Time Perspective: Prospective
Progression-free survival
Measure response or progression events via all available imaging studies, including Chest-Xray, CT scans, or MRI, PET study. The relationship between CTCs number and time from CTCs checkpoint to disease progression will be analyzed.
one year
Yes
Chia-Hsun C Hsieh, M.D, M.S.
Principal Investigator
Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Linkou
Taiwan: Institutional Review Board
CTCHNSCC01
NCT01884129
October 2011
October 2015
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