Investigating immune responses in head and neck cancer patients undergoing advanced radiotherapy
Circulating Immunes Cells, Cytokines and Brain Radiotherapy
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Francois Baclesse Academic / other |
| Drugs / interventions | cetuximab, Chemotherapy, radiation |
| Locations | 1 site (Caen) |
| Trial ID | NCT05082961 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with operable head and neck cancer who are undergoing postoperative radiotherapy.
Not a fit: Patients with macroscopic tumor residue or those who have had previous cancers or radiotherapy may not benefit from this study.
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 performed: While there is limited research specifically on immune responses to proton and carbon therapies, similar studies in other cancer types have shown promising results.
Eligibility criteria
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 this trial is running
Caen
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.