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Prognostic Value of Circulating Tumor Cells in Patients With Locally Advanced and Metastatic/Recurrent Head and Neck Cancer


N/A
20 Years
N/A
Open (Enrolling)
Both
Recurrence, Metastasis, Death

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Trial Information

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.


Inclusion Criteria:



- histologically or cytopathologically proven head and neck squamous cell carcinoma Age
≥ 20 years. Measurable or evaluable disease according to Response Evaluation Criteria
In Solid Tumors(RECIST) criteria.

Ability to sign informed consent.

Exclusion Criteria:

- Prior cancers within 5 years, except for non-melanoma skin cancers, and in situ
cervical cancers.

Inability to comply with study and/or follow-up procedures.

Type of Study:

Observational [Patient Registry]

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Progression-free survival

Outcome Description:

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.

Outcome Time Frame:

one year

Safety Issue:

Yes

Principal Investigator

Chia-Hsun C Hsieh, M.D, M.S.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Linkou

Authority:

Taiwan: Institutional Review Board

Study ID:

CTCHNSCC01

NCT ID:

NCT01884129

Start Date:

October 2011

Completion Date:

October 2015

Related Keywords:

  • Recurrence
  • Metastasis
  • Death
  • Circulating tumor cells
  • Head and neck cancer
  • Squamous cell carcinoma
  • Survival
  • Prognosis
  • Head and Neck Neoplasms
  • Neoplastic Cells, Circulating
  • Neoplasm Metastasis
  • Recurrence

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