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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Circulating tumor cells (CTCs) testing
研究概览
简要总结
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.
详细描述
The aim 1 of this trial is the development of the CTC definition of oral cancer 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 OCSCC) and treatment mode (extended adjuvant chemotherapy with low-dose oral chemotherapy). The survival rate of patients will be improved.
This three-year study is expected to recruit 100 oral cavity cancer patients with extracapsular nodal extension (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.
For the negative selection of CTCs by the negative selection system. For the positive selection of CTCs by counting Epithelial cell adhesion molecule(EpCAM)-positive and Hoechst-positive cells under a microscope with a hemocytometer.
In brief, CTC could predict a poor prognosis in HNSCC patients. But the role of longitudinal CTC follow-up in ENE+ oral cavity cancer patients remains unclear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Presence of psychiatric disorders.
- •Deemed unsuitable for participation by the attending physician.
- •Unwilling to participate in the study.
结局指标
主要结局
Circulating tumor cells (CTCs) testing
时间窗: 9 month
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.
Circulating tumor cells (CTCs) testing
时间窗: baseline
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.
Circulating tumor cells (CTCs) testing
时间窗: 3 month
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.
Circulating tumor cells (CTCs) testing
时间窗: 6 month
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.
次要结局
未报告次要终点
研究者
Chun-Ta Liao
Professor Attending Physicians
Chang Gung Memorial Hospital