Clinical trial NCT05582122: SURVEILLE-HPV: Evaluation of HPV16 Circulating DNA as Biomarker to Detect the Recurrence, in Order to Improve Post Therapeutic Surveillance of HPV16-driven Oropharyngeal Cancers
Official title: SURVEILLE-HPV: National, Multicenter, Open-label, Randomized, Phase II Study Evaluating HPV16 Circulating DNA as Biomarker to Detect the Recurrence, in Order to Improve Post Therapeutic Surveillance of HPV16-driven Oropharyngeal Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Oropharynx Squamous Cell Carcinoma
Keywords: HPV16
CtDNA
Lead sponsor: UNICANCER
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: Inclusion Criteria:

1. Patient aged 18 years or over
2. Patient with p16 positive Oropharyngeal squamous cell carcinoma (OPSCC)
3. Clinical stage T1-4, N0-3, M0 (stages I-III)
4. Any tobacco status
5. Life expectancy greater than 36 months
6. Positive HPV16 Ct-DNA measured before curative anticancer treatment
7. Treated by any curative treatment
8. Complete response at 3 months after end of treatment, which means:

   * Undetectable HPV16 Ct-DNA and no residual disease on imaging (group A) or
   * Undetectable HPV16 Ct-DNA and suspicious imaging but persistent disease excluded by either biopsy or repeated imaging (group B1) or
   * Positive HPV16 Ct-DNA and no residual disease on imaging but negative HPV16 Ct-DNA on the subsequent assessment. This second test will be done 1-2 months after the first one (group C1).
9. Patient must be affiliated to a Social Security System (or equivalent)
10. Patients must have signed a written informed consent form prior to any trial specific procedures. If the patient is physically unable to give his/her written consent, a trusted person of his/her choice, note related to the investigator or the sponsor, can confirm in writing the patient's consent.

Exclusion Criteria:

1. Uncontrolled intercurrent illness that would limit compliance with study requirements.
2. 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.
3. Any other HPV induced cancer within 5 years
4. 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
5. Patient unwilling or unable to comply with the study protocol and follow-up schedule.
6. Participation in another clinical trial with an investigational medical product during the last 30 days prior to the inclusion and during the present study (except if patient is included in the control arm, with placebo or with a product that have a marketed authorization, used as per the summary of product characteristics (SmPC) for the given indication).
7. Patient deprived of liberty or placed under protective custody or guardianship.

Primary outcomes:
measure: Negative Predictive Value (NPV) of HPV16 ct-DNA
timeFrame: 24 months
Secondary outcomes:
measure: 5- year Negative Predictive Value
timeFrame: 48 and 60 months
measure: Positive Predictive Value (PPV) of HPV16 ct-DNA
timeFrame: 18, 24, 48, and 60 months
measure: Rate of relapses detected by HPV16 ct-DNA
timeFrame: 5.5 years
measure: Disease-free survival
timeFrame: 5.5 years
measure: Loco-Regional recurrence
timeFrame: From randomization to disease recurrence, up to 5.5 years
measure: Time of distant recurrence
timeFrame: From randomization to disease recurrence, up to 5.5 years
measure: Overall survival
timeFrame: From randomization to death from any cause, up to 5.5 years
measure: Cost-effectiveness analysis of the proposed strategy
timeFrame: 5.5 years
Other outcomes:
Locations:
city: Saint-Denis
country: France
facility: Clinique St Vincent- Réunion
state: La Réunion
city: Avignon
country: France
facility: ISC Avignon
city: Dijon
country: France
facility: Georges-François Leclerc
city: Lille
country: France
facility: Oscar Lambret- Lille
city: Marseille
country: France
facility: La Timone-AP-HM Marseille
city: Nice
country: France
facility: Antoine Lacassagne - NICE
city: Nîmes
country: France
facility: CHU De Nîmes ICG
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Institut Curie - Paris
city: Paris
country: France
facility: TENON - APHP Paris
city: Rennes
country: France
facility: Eugène Marquis-Rennes
city: Saint-Herblain
country: France
facility: ICO - Site St Herblain
city: Strasbourg
country: France
facility: ICANS Strasbourg
city: Toulouse
country: France
facility: IUCT Oncopole Toulouse
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de cancérologie de Lorraine
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
References: