Clinical trial NCT01884129: Prognostic Value of CTC in HNSCC Patients
Official title: Prognostic Value of Circulating Tumor Cells in Patients With Locally Advanced and Metastatic/Recurrent Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Recurrence
Metastasis
Death
Keywords: Circulating tumor cells
Head and neck cancer
Squamous cell carcinoma
Survival
Prognosis
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 53
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Locally advanced or recurrent/metastatic head and neck cancer

Brief summary: We hypothesized that the number of circulating tumor cells (CTCs) and molecular markers on CTCs could be a prognostic factor or predictive factor to patients with head neck cancer.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival
timeFrame: one year
Secondary outcomes:
Other outcomes:
measure: Overall survival
timeFrame: one year
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Linkou
name: Chia-Hsun C Hsieh, M.D, M.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsieh JC, Lin HC, Huang CY, Hsu HL, Wu TM, Lee CL, Chen MC, Wang HM, Tseng CP. Prognostic value of circulating tumor cells with podoplanin expression in patients with locally advanced or metastatic head and neck squamous cell carcinoma. Head Neck. 2015 Oct;37(10):1448-55. doi: 10.1002/hed.23779. Epub 2014 Jul 24.