Prognostic Value of CTC in HNSCC Patients

Recurrence Clinical Trial

— CTCHNSCC01  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01884129
• Other study ID #: CTCHNSCC01
• Secondary ID: CMRPG3B0971~3
• Status: Terminated
• Phase: N/A
• First received: June 10, 2013
• Last updated: December 9, 2015
• Start date: June 2012
• Est. completion date: May 2015

Study information

• Verified date: February 2013
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 53
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Death
• Metastasis
• Neoplastic Cells, Circulating
• Recurrence

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival	All causes of death would be documented and the relationship between CTCs number and time from CTCs checkpoint to death will be analyzed.	one year	Yes
Primary	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