Circulating Tumor Cell Counts in Postoperative ENE-Positive Oral Cavity Cancer Patients After Adjuvant CCRT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorChang Gung Memorial Hospital
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Presence of psychiatric disorders.
Deemed unsuitable for participation by the attending physician.
Unwilling to participate in the study.
Trial design
Design model
Parallel
Treatments tested in this trial
low-dose oral chemotherapy
Procedure/Surgeryrecruit 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: controlNo intervention 0 interventions
Group B: experimentalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Circulating tumor cells (CTCs) testing
participants will undergo CTCs testing after completing concurrent Chemoradiotherapy (CCRT). If CTC-positive (≥5.0 cells/mL), participants will receive low-dose oral chemotherapy for three months, followed by repeat CTC testing. Persistent positivity will warrant continued treatment up to one year after curative surgery, while negativity will lead to treatment discontinuation.
Time frame
baseline2
Circulating tumor cells (CTCs) testing
participants will undergo CTCs testing after completing concurrent Chemoradiotherapy (CCRT). If CTC-positive (≥5.0 cells/mL), participants will receive low-dose oral chemotherapy for three months, followed by repeat CTC testing. Persistent positivity will warrant continued treatment up to one year after curative surgery, while negativity will lead to treatment discontinuation.
Time frame
3 month3
Circulating tumor cells (CTCs) testing
participants will undergo CTCs testing after completing concurrent Chemoradiotherapy (CCRT). If CTC-positive (≥5.0 cells/mL), participants will receive low-dose oral chemotherapy for three months, followed by repeat CTC testing. Persistent positivity will warrant continued treatment up to one year after curative surgery, while negativity will lead to treatment discontinuation.
Time frame
6 month4
Circulating tumor cells (CTCs) testing
participants will undergo CTCs testing after completing concurrent Chemoradiotherapy (CCRT). If CTC-positive (≥5.0 cells/mL), participants will receive low-dose oral chemotherapy for three months, followed by repeat CTC testing. Persistent positivity will warrant continued treatment up to one year after curative surgery, while negativity will lead to treatment discontinuation.
Time frame
9 monthSponsors and contacts
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Source ClinicalTrials.gov