Circulating Tumor Cell Counts in Postoperative ENE-Positive Oral Cavity Cancer Patients After Adjuvant CCRT

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Oral Cancer; Head and Neck Cancer

Treatments: Procedure: low-dose oral chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07296250

202402125B0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 months to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

control

No Intervention group

Description:

participants without low-dose oral chemotherapy. Each patient must continue to be tracked for ENE or other postoperative risks for one year, and with blood testing every tree month.

experimental

Experimental group

Description:

participants with low-dose oral chemotherapy. Each patient must continue to be tracked for ENE or other postoperative risks for one year, and with blood testing every tree month.

Treatment:

Procedure: low-dose oral chemotherapy