RecruitingNot ApplicableNCT07296250

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

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

Sponsor

Chang Gung Memorial Hospital

Enrollment

100 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Head and Neck Cancer Oral Cancer

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.

Eligibility

Min Age: 18 MonthsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study measures circulating tumor cells (cancer cells in the bloodstream) in patients with head and neck cancer who are receiving radiation and chemotherapy after surgery, to track treatment response and predict outcomes. **You may be eligible if...** - You are between 18 and 90 years old - You have been diagnosed with head and neck squamous cell carcinoma (a common type of head and neck cancer) - You have completed surgery and have been identified as high-risk, and are now undergoing concurrent chemoradiotherapy - You are willing to attend follow-up visits **You may NOT be eligible if...** - You have a psychiatric disorder - Your doctor considers you unsuitable for participation - You are unwilling to take part in the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.