Monitoring circulating tumor cells in postoperative ENE-positive oral cavity cancer after adjuvant concurrent chemoradiation.
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
This trial will test whether regular blood monitoring of circulating tumor cells and adding extended low-dose oral chemotherapy can help people with ENE-positive oral cavity squamous cell carcinoma after surgery and adjuvant concurrent chemoradiation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Months to 90 Years |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Taoyuan City) |
| Trial ID | NCT07296250 on ClinicalTrials.gov |
What this trial studies
The protocol has two aims: first to define a circulating tumor cell (CTC)-based minimal residual disease (MRD) marker for oral cavity squamous cell carcinoma, and second to run a prospective treatment arm using extended low-dose oral chemotherapy. The study plans to enroll about 100 postoperative patients with extracapsular nodal extension (ENE) or other high-risk features and follow them for one year, drawing 10 mL of research blood at baseline and every three months for CTC analysis. CTCs will be isolated using a negative-selection system and counted by EpCAM and Hoechst staining under microscopy to identify single CTCs and circulating tumor microemboli. The investigators will correlate longitudinal CTC counts with clinical recurrence and survival to determine whether CTC-MRD can guide extended adjuvant therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–90 with histologically confirmed head and neck squamous cell carcinoma of the oral cavity who have completed surgery, have high-risk features such as ENE, and have finished adjuvant concurrent chemoradiation and are willing to return for regular follow-up.
Not a fit: Patients who do not have ENE or other postoperative high-risk features, who are medically or psychiatrically unsuitable, or who are unwilling to comply with follow-up visits and blood draws are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could provide a standard blood-based MRD test and an extended low-dose oral chemotherapy option that may improve survival for ENE-positive oral cavity cancer patients.
How similar studies have performed: Prior studies have shown that CTC presence can predict poorer prognosis in head and neck cancers, but longitudinal CTC-guided MRD and extended adjuvant low-dose chemotherapy in ENE-positive oral cavity cancer remains largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Taoyuan City
- Linkou Chang Gung Memorial Hospital — Taoyuan City, Taiwan (Recruiting)
Study contacts
- Principal investigator: ChunTa Liao, PhD — Division of Otolaryngology, Chang Gung Memorial Hospital
- Study coordinator: ChunTa Liao, PhD
- Email: liaoct@cgmh.org.tw
- Phone: 0975360141
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.