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)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 18

ECOG 0-2

HPV-16 squamous cell carcinoma of the oropharynx or HPV-16 head and neck squamous cell carcinoma of unknown primary . HPV status must be confirmed by in-situ hybridization.

HPV ctDNA detectable by HPV digital PCR (Naveris assay) with a minimum of 50 copies/mL pre-operatively.

Disqualifiers

Metastatic disease

Non-HPV16 genotype (i.e. HPV-18,-31, -33, -35)

Patients who receive surgery at outside institution. Exceptions can be made for high-volume surgical centers at the discretion of the PI/co-PI

Prior head and neck radiation

Trial design

Treatments tested in this trial

  • HPV ctDNA Assay
  • MRI Studies
  • EORTC QLQ H&N 35 and C30
  • MDADI-HN
  • COST-FACIT
  • Intensity-Modulated Radiation Therapy (Arm A)
  • Chemoradiation (Arm B)

Treatment groups

30 Participants
are divided into 2 treatment groups