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Recruiting NCT07296250

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

No phase Interventional Head and Neck Cancer Oral Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: low-dose oral chemotherapy.
Who it may be relevant to
Registry conditions: Head and Neck Cancer, Oral Cancer. Basic parameters: 18 months — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Prospective Phase II Clinical Trial - Extended Chemotherapy or Not Based on Circulating Tumor Cell Counts in Postoperative ENE-Positive Oral Cavity Cancer Patients After Completing Adjuvant Concurrent Chemoradiotherapy

Overview

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

  • Procedure low-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.

Primary outcome measures

  • Circulating tumor cells (CTCs) testing [Time frame: baseline]
  • Circulating tumor cells (CTCs) testing [Time frame: 3 month]
  • Circulating tumor cells (CTCs) testing [Time frame: 6 month]
  • Circulating tumor cells (CTCs) testing [Time frame: 9 month]

Eligibility criteria

Inclusion criteria

Participants with Cancer:

  • Aged between 18 and 90 years.
  • Histologically confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC).
  • Completed surgical treatment and identified as having high-risk factors, followed by concurrent chemoradiotherapy.
  • Willing to continue follow-up visits at the hospital after completion of treatment.

Exclusion criteria

  • Presence of psychiatric disorders.
  • Deemed unsuitable for participation by the attending physician.
  • Unwilling to participate in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

Taiwan · 1 center
  • Linkou Chang Gung Memorial Hospital — Taoyuan City

Identifiers

NCT: NCT07296250 · 202402125B0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗