Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| low-dose oral chemotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- control
- description
- participants without low-dose oral chemotherapy. Each patient must continue to be tracked for ENE or other postoperative risks for one year, and with blood testing every tree month.
- type
- EXPERIMENTAL
- label
- experimental
- description
- participants with low-dose oral chemotherapy. Each patient must continue to be tracked for ENE or other postoperative risks for one year, and with blood testing every tree month.
- interventionNames
- Procedure: low-dose oral chemotherapy
Primary outcomes (4)
- measure
- Circulating tumor cells (CTCs) testing
- timeFrame
- baseline
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Months
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available