About this trial
SURVEILLE-HPV - A new post therapeutic surveillance strategy for HPV-driven oropharyngeal cancer based on HPV Circulating DNA measures.
HPV-positive oropharyngeal cancer patients have a much better prognosis that their HPV-negative counterparts. Despite this, Post Treatment Surveillance (PTS) strategy does not take into account HPV status.
HPV Circulating DNA (HPV Ct DNA) has emerged as a promising tool to assess the risk of cancer recurrence following treatment. We assume that this biomarker could be helpful to guide PTS.
The number of systematic PTS visits could be significantly reduced in patients with undetectable HPV Ct DNA whereas a closer clinical and radiological follow up could be performed in case of detectable HPV Ct DNA.
If confirmed, this new strategy could have several benefits including:
* reduction of PTS visits for most HPV-positive patients which implies a potential cost decrease and * Identification of relapse at early stages (before the occurrence of symptoms)
Eligibility criteria
Qualifiers
Patient aged 18 years or over
Patient with p16 positive Oropharyngeal squamous cell carcinoma (OPSCC)
Clinical stage T1-4, N0-3, M0 (stages I-III)
Any tobacco status
Disqualifiers
Uncontrolled intercurrent illness that would limit compliance with study requirements.
Active invasive malignancy within 3 years of inclusion except for non-invasive malignancies such as non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured.
Any other HPV induced cancer within 5 years
Any condition that may jeopardize the patient participation as well as non-contraception for male and female with child-bearing potential, pregnancy or breast-feeding
Trial design
Treatments tested in this trial
- HPV16 Ct-DNA dosing
Treatment groups
Locations
16Sponsors and collaborators
UNICANCER
Lead sponsor