Prediction of Residual Disease by Circulating DNA Detection After Potentiated Radiotherapy for Locally Advanced Head and Neck Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-17

Study Completion Date

2031-07-31

Brief Summary

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Sixty percent of newly diagnosed head and neck squamous cell carcinomas (HNSCCs) are at a locally advanced (LA) stage. Depending on tumor site, stage, and resectability, locoregional failure rates can range from 35% to 65%. The persistence of residual disease at the end of treatment is a major prognostic element but is not always reliably assessed by current imaging techniques. Up to 40-50% of patients have residual adenomegaly and only 30% have viable disease when further adenectomy is performed. Sensitive and reproducible detection of residual disease after treatment is a major challenge in this patient category.

18F-fluorodeoxyglucose (18F-FDG) positron emission tomography-computed tomography (PET/CT) guided surveillance, with a negative predictive value of 95-97%, has proven to be non-inferior to cervical curage in HNSCCs with residual adenomegaly. Cervical curage is now indicated only if the response assessed by PET-CT is incomplete. Nevertheless, the ability of PET-CT to predict treatment failure is unsatisfactory due to a high frequency of false positives, because of inflammatory changes, with a positive predictive value of about 20-50%.

Circulating tumor DNA (ctDNA) may provide a more reliable assessment of response to potentiated radiotherapy. Liquid biopsy monitoring of response in patients treated with potentiated radiation therapy for locally advanced HNSCCs a has been shown to be feasible. In 85% of patients, ctDNA is detectable and correlates significantly with tumor volume and response to treatment. In addition, one study showed that post-radiotherapy analysis of circulating HPV16 viral DNA (cvDNA) in patients with HPV16-related HNSCCs complemented PET-CT and helped guide management decisions. HPV16 cvDNA and PET-CT have similar negative predictive values, whereas the positive predictive value is higher for HPV16 cvDNA (100% versus 50%). Nevertheless, current data are insufficient to allow routine use of this marker.

This is a multicenter, single arm, open study for patients with a locally advanced head and neck cancer for which a potentiated radiotherapy is indicated.

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Detailed Description

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Conditions

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Locally Advanced Head and Neck Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Biological samples of patients included in the study (i.e., patients treated with radiochemotherapy for a locally advanced head and neck cancer) will be analysed (Next generation sequencing (NGS)):

* At inclusion : a FFPE block + a blood sample to identify tumor specific variants (tcDNA and cvDNA)
* 3 months after radiotherapy in case of incomplete response (PET-CT) : a blood sample to search if the tumor specific variants identified before the treatment are found

Patients with incomplete response after 3 months radiochemotherapy will undergone a salvage adenectomy.

The main objective is to assess the ability of circulating DNA to predict residual disease during salvage adenectomy.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Interventional

Group Type EXPERIMENTAL

Blood sample

Intervention Type BIOLOGICAL

The intervention consist in a blood sample that will be taken twice :

* at the inclusion (before treatment)
* 3 months after the radiochemotherapy in case of incomplete response (PET-CT)

Interventions

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Blood sample

The intervention consist in a blood sample that will be taken twice :

* at the inclusion (before treatment)
* 3 months after the radiochemotherapy in case of incomplete response (PET-CT)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years and ≤ 80 years
* Histologically confirmed, never treated squamous cell carcinoma with lymph node involvement
* squamous cell carcinoma p16+or p16-, stage III (N1), IVa or IVb (UICC classification 8th edition), N1 minimum, and oropharyngeal sqamous cell carcinomas p16+ stage I or II, N1 minimum, resectable but not operated or unresectable, with indication for concomitant or sequential radiochemotherapy with induction chemotherapy using Docetaxel, Platinum, 5-Fluorouracil (TPF or modified TPF according to the practices of the investigating centers)
* Oral cavity, oropharynx, hypopharynx or larynx, cervical adenopathies without primary
* Availability of FFPE samples prior to treatment initiation
* Detection of circulating DNA in the initial blood sample
* Obtaining informed consent from the patient
* Affiliation to the French social security system

Exclusion Criteria

* Tumor of the nasopharynx, sinuses, nasal cavity, salivary glands or thyroid cancer
* Treatment by exclusive radiotherapy
* Contraindication to cervical lymph node dissection
* Metastatic disease (stage IVc)
* Previous treatment for head and neck cancer
* History of other cancer in the last 3 years (except carcinoma in situ, basal cell skin carcinoma, localized prostate cancer Gleason 6)
* Pregnant or breastfeeding woman
* Patient under guardianship or curators
* Psychological disorder (cognitive disorders, vigilance disorders, etc.) or social reasons (deprivation of liberty by judicial or administrative decision) or geographical reasons that could compromise the medical follow-up of the trial or compliance with the treatment

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No