drugset / Trial / NCT05307939

A Study on Using Cell-Free Tumor DNA (ctDNA) Testing to Decide When to StartRoutine Treatment in People With Human Papilloma Virus (HPV)- Associated Oropharynx Cancer (OPC)

NCT05307939 ↗

Phase 2 Recruiting 30 enrolled Memorial Sloan Kettering Cancer Center
Non-randomizedParallel-groupOpen-labelDiagnostic

Summary

This study will look at whether monitoring HPV ctDNA levels is an effective way to detect cancer relapse risk in people with HPV-OPC. All participants will have recently had surgery to treat their disease, or they will be scheduled to have this surgery. In Arm A the researchers will see whether monitoring participants' HPV ctDNA levels can safely identify patients who do not need radiation therapy (RT) after surgery and whose RT can be delayed until their HPV ctDNA levels become detectable. In Arm B, the researchers will see whether patients who usually need 6-6.5 weeks of CRT can be selected by HPV ctDNA to receive 3 weeks of CRT.

Timeline

Start
2022-03-24
Primary completion
2027-03-24
Completion
2027-03-24

Drugs

EvaluationDrugModalityDoseRoute
Background Carboplatin Small molecule — —
Background Cisplatin Other / unclassified — —
Background fluorouracil Small molecule — —