Actively Recruiting
A Randomized, Prospective Trial of Extended Chemotherapy Based on Circulating Tumor Cell Counts in Postoperative ENE-Positive Oral Cavity Cancer Patients After Adjuvant Concurrent Chemoradiotherapy
Led by Chang Gung Memorial Hospital · Updated on 2025-12-22
100
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of circulating tumor cells (CTCs) as a way to define minimal residual disease (MRD) in oral cavity squamous cell carcinoma (OCSCC) and to evaluate treatment approaches for oral cancer patients. The study aims to develop a standard diagnostic tool for MRD and assess the impact of extended low-dose oral chemotherapy after surgery and chemoradiotherapy. This research hopes to improve the survival rates of patients with this type of cancer. The trial involves about 100 patients with oral cavity cancer who have extracapsular nodal extension (ENE) or other postoperative risks. Participants are randomly assigned to either receive low-dose oral chemotherapy or no additional chemotherapy after completing concurrent chemoradiotherapy. Blood samples are collected four times during the study to monitor circulating tumor cells, and patients are tracked for one year with blood tests every three months to observe their condition. Participants will undergo blood draws to measure CTCs at baseline and at 3, 6, and 9 months after treatment. Researchers will monitor treatment effects and track disease progression through these regular assessments. Follow-up visits continue for one year to evaluate postoperative risks and treatment outcomes. The study does not involve masking, and its main outcome focuses on CTC testing at multiple timepoints throughout the year.
CONDITIONS
Brief Title
Circulating Tumor Cell Counts in Postoperative ENE-Positive Oral Cavity Cancer Patients After Adjuvant CCRT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 90 years
- Histologically confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC)
- Completed surgical treatment with high-risk factors
- Completed concurrent chemoradiotherapy
- Willing to continue follow-up visits at the hospital after treatment completion
You will not qualify if you...
- Presence of psychiatric disorders
- Deemed unsuitable for participation by the attending physician
- Unwilling to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive either low-dose oral chemotherapy or no chemotherapy after surgery and chemoradiotherapy.
Visits every 3 months for blood testing and monitoring
Duration - 1 year
Participants are followed to track postoperative risks including extracapsular nodal extension (ENE) through regular blood testing for circulating tumor cells.
Blood testing every 3 months (4 times total)
Trial Site Locations
Total: 1 location
1
Linkou Chang Gung Memorial Hospital
Taoyuan City, Taiwan, 333423
Actively Recruiting
Research Team
C
ChunTa Liao, PhD
C
Chia-Hsun Hsieh, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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