Phase II Trial of Extended Chemotherapy Based on Circulating Tumor Cell Counts for Postoperative Patients With ENE-Positive Oral Cavity Cancer After Completing Adjuvant Chemoradiotherapy

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.

Circulating Tumor Cell Counts in Postoperative ENE-Positive Oral Cavity Cancer Patients After Adjuvant CCRT