Adjuvant Chemotherapy for Locally Advanced Cervical Cancer Patients Positive for HPV DNA in Plasma After Standard Chemoradiotherapy

What this Trial Is About

Researchers are investigating whether patients with locally advanced cervical cancer who still have detectable cell-free human papillomavirus DNA cfHPV-DNA in their plasma after standard treatment may benefit from additional chemotherapy. This trial is a prospective, randomized, multicenter clinical study designed to evaluate adjuvant chemotherapy based on this biomarker. The study focuses on patients who have undergone chemoradiotherapy and have persistent cfHPV-DNA, as this may indicate ongoing disease activity. Participants first receive standard treatment with concomitant chemoradiotherapy, including doses of radiation and weekly cisplatin. Four weeks after completing this treatment, a blood test is conducted to detect cfHPV-DNA in plasma. Patients with positive cfHPV-DNA results are randomly assigned to either receive two additional cycles of adjuvant chemotherapy with cisplatin and gemcitabine or to be monitored without further chemotherapy. Patients in both groups undergo regular follow-up every four months, including plasma cfHPV-DNA testing, CT scans of the chest, MRI scans of the abdomen and pelvis, and clinical and gynecological exams. During the study, participants are closely monitored for progression-free survival, overall survival, treatment response, quality of life, and any toxic effects of treatment. Follow-up assessments occur at regular intervals from 7 to 120 days after treatment. The total duration of participant involvement varies based on follow-up schedules. The study uses a single-blind design and randomized allocation to ensure scientific rigor while maintaining patient safety throughout the trial period.

Adjuvant Chemotherapy in cfHPV-DNA Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer