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

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

Inclusion Criteria5

  • 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 Criteria3

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

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.


Locations(1)

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan

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NCT07296250


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