Investigating immune responses in head and neck cancer patients undergoing advanced radiotherapy
Official title: Circulating Immunes Cells, Cytokines and Brain Radiotherapy
Run by Centre Francois Baclesse · NCT05082961 · Data updated 2026-11-12
This study is testing how two advanced types of radiotherapy affect the immune response in patients with head and neck cancer after surgery to see if they can improve treatment outcomes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Centre Francois Baclesse Academic / other |
| Drugs / interventions | cetuximab, Chemotherapy, radiation |
| Locations | 1 site (Caen) |
| Status | Recruiting |
| Started | January 27, 2022 |
| Main results expected | April 2028 |
| Study ends | October 2028 |
| Registry record updated | December 11, 2024 |
| Trial ID | NCT05082961 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old with operable head and neck cancer who are undergoing postoperative radiotherapy.
✕Probably not a fit
Patients with macroscopic tumor residue or those who have had previous cancers or radiotherapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study focuses on patients with head and neck cancer who have undergone surgery and are receiving postoperative radiotherapy. It aims to collect blood samples to evaluate the immune response following treatment with proton or carbon ion therapy, which are believed to be more effective and less damaging than traditional radiotherapy. The research seeks to understand how these therapies influence inflammation and immune cell activity, which are crucial for tumor development and treatment response. By analyzing these immune parameters, the study hopes to improve treatment strategies for this challenging cancer type.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols that enhance patient outcomes in head and neck cancer.
How similar studies have gone: While there is limited research specifically on immune responses to proton and carbon therapies, similar studies in other cancer types have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients \> 18 years * Head and neck cancer: (upper aerodigestive tract, cavum, facial sinus, skull base, brain) operated * Surgery for complete tumour resection or with microscopic residue R1 * All possible histologies: squamous cell carcinoma, undifferentiated carcinoma of the nasopharyngeal type (UCNT), adenocarcinoma, adenoid cystic carcinoma, chordoma, chondrosarcoma,meningioma other tumours * Patients undergoing exclusive postoperative radiotherapy with a minimum total dose of 54 Gy of X-ray photon radiation or equivalent proton radiation. * Patient affiliated to a social security scheme * Signature of the informed consent before any specific procedure related to the study Exclusion Criteria: * Macroscopic postoperative tumour residue R2 * Previous cancer within 5 years (except treated basal cell skin carcinoma and treated cervical cancer). * Previous radiotherapy (except brachytherapy of the cervix or prostate) * Chemotherapy or other systemic oncological treatment (cetuximab) concomitant with radiotherapy * Long-term immunosuppressive or corticosteroid therapy * Patient deprived of liberty or under guardianship, protected adult * Patient unable to undergo trial monitoring for geographical, social or psychopathological reasons * Pregnant or breastfeeding woman * Emergency situations
Where it's running
-
Centre François Baclesse
Caen, France Recruiting
Study contacts
- Study coordinator: Mathieu CESAIRE, MD
- Email: m.cesaire@baclesse.unicancer.fr
- Phone: +33 (0)2 31 45 50 20
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.