Head and Neck Cancer, Oral Cancer
Conditions
Keywords
oral cancer, ENE, Circulating tumor cells, Adjuvant concurrent Chemoradiation, adjuvant CCRT, Circulating tumor microemboli (CTM)
Brief summary
The aim 1 of this trial is the development of the Circulating tumor cells (CTCs) definition of oral cancer minimal residual disease (MRD), and aim 2 is a prospective trial of oral cancer treatment. If this trial is successful, it is expected that it may be able to provide a standard diagnostic tool (MRD in Oral Cavity Squamous Cell Carcinoma (OCSCC)) and treatment mode (extended adjuvant chemotherapy with low-dose oral chemotherapy). The survival rate of patients will be improved.
Detailed description
The aim 1 of this trial is the development of the CTC definition of oral cancer MRD, and aim 2 is a prospective trial of oral cancer treatment. If this trial is successful, it is expected that it may be able to provide a standard diagnostic tool (MRD in OCSCC) and treatment mode (extended adjuvant chemotherapy with low-dose oral chemotherapy). The survival rate of patients will be improved. This three-year study is expected to recruit 100 oral cavity cancer patients with extracapsular nodal extension (ENE) or other postoperative risks.10 mL of research blood was drawn four times in total.Each patient must continue to be tracked for ENE or other postoperative risks for one year, and with blood testing every tree month. For the negative selection of CTCs by the negative selection system. For the positive selection of CTCs by counting Epithelial cell adhesion molecule(EpCAM)-positive and Hoechst-positive cells under a microscope with a hemocytometer. In brief, CTC could predict a poor prognosis in HNSCC patients. But the role of longitudinal CTC follow-up in ENE+ oral cavity cancer patients remains unclear.
Interventions
PROCEDURElow-dose oral chemotherapy
recruit 100 oral cavity cancer patients with ENE or other postoperative risks.10 mL of research blood was drawn four times in total.Each patient must continue to be tracked for ENE or other postoperative risks for one year, and with blood testing every tree month.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Months to 90 Years
Healthy volunteers
Yes
Inclusion criteria
Participants with Cancer: 1. Aged between 18 and 90 years. 2. Histologically confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC). 3. Completed surgical treatment and identified as having high-risk factors, followed by concurrent chemoradiotherapy. 4. Willing to continue follow-up visits at the hospital after completion of treatment.
Exclusion criteria
1. Presence of psychiatric disorders. 2. Deemed unsuitable for participation by the attending physician. 3. Unwilling to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Circulating tumor cells (CTCs) testing | baseline | participants will undergo CTCs testing after completing concurrent Chemoradiotherapy (CCRT). If CTC-positive (≥5.0 cells/mL), participants will receive low-dose oral chemotherapy for three months, followed by repeat CTC testing. Persistent positivity will warrant continued treatment up to one year after curative surgery, while negativity will lead to treatment discontinuation. |
Countries
Taiwan
Contacts
Primary ContactChunTa Liao, PhD
Backup ContactChia-Hsun Hsieh, PhD
Outcome results
None listed