Multimodal Prediction of Response to Chemoradiotherapy fo... | NCT07259915

Studies
Multimodal Prediction of Response to Chemoradiotherapy for Squamous Cell Carcinoma of the Head and Neck

NCT07259915

Sponsor

Centre Henri Becquerel

Status

Not yet recruiting

Last Update Posted

Dec 2, 2025Actual

Enrollment

152Estimated

Phase

Not Applicable

Conditions

Squamous Cell Cancer of Head and Neck (SCCHN)

Interventions

Multimodal approach

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2025Estimated

Primary Completion Date

Aug 1, 2030Estimated

Completion Date

Aug 1, 2030Estimated

First Submitted Date

Nov 21, 2025

First Submission Date that Met QC Criteria

Nov 21, 2025

First Posted Date

Dec 2, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2025

Last Update Posted Date

Dec 2, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

152Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Multimodal approach	Experimental	The patient will undergo multimodal imaging and biological sampling	Other: Multimodal approach

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multimodal approach	Other	The patient will undergo MRI, PET/can and biological samples	Multimodal approach

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Performance of multimodal approach to predict response to chemoradiation	Estimation of the area under the curve associated with the overall performance of the combined score established by the multimodal approach (PET/CT, MRI, CT, circulating tumor DNA, lymph node tumor DNA) in the post-CRT assessment of the status of a locoregional response within 12 months after chemoradiation.	12 months after treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with squamous cell carcinoma of the oropharynx (cT2-cT4) or squamous cell carcinoma of the oral cavity (cT2-cT4)
With lymph node involvement (cN1, cN2, or cN3) (confirmation of lymph node involvement after review of imaging in CCP and without histological confirmation required)
Eligible for curative treatment with cisplatin-based chemoradiotherapy alone (100 mg/m2 every 3 weeks or 40 mg/m2 weekly)
Regardless of p16 status
Affiliated with or covered by a social security system

Exclusion Criteria:

Head and neck squamous cell carcinomas in other locations (salivary gland, larynx, hypopharynx, cavum, sinuses)
Primary squamous cell carcinoma of the lymph nodes
History of radiotherapy to the head and neck region
Radiochemotherapy not based on the use of cisplatin
Pregnant or breastfeeding women
History of invasive cancer in the last 3 years (except for Breslow melanoma less than 1 mm)
Contraindication to MRI, CT, or PET/CT
Allergy or contraindication to iodine, gadolinium, or 18F-FDG
Uncontrolled diabetes (fasting blood glucose greater than 12 mmol/l)
Patients unable to understand the study for any reason or to comply with the trial requirements (language, psychological, geographical issues, etc.)
Patients under guardianship or conservatorship
Patients deprived of their liberty by judicial or administrative decision
Patients undergoing psychiatric care that renders them incapable of giving their consent
Patients admitted to a health or social care facility for purposes other than research

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Lise-Marie Roussel, MD	Contact	+33276015781		lise-marie.roussel@chb.unicancer.fr
Doriane Richard, PhD	Contact	+33232082985		doriane.richard@chb.unicancer.fr