Image-guided proton therapy for advanced head and neck cancer
Proton Image-guided Radiation Assignment for Therapeutic Escalation Via Selection of Locally Advanced Head and Neck Cancer Patients
This study is testing a new way to use proton therapy combined with chemotherapy to see if it can safely deliver a higher dose to treat advanced head and neck cancer while protecting healthy tissue.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 17 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Groningen) |
| Trial ID | NCT06446713 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and feasibility of using image-guided mid-treatment hyper-fractioned dose-escalation with proton therapy for patients with locally advanced HPV-negative squamous cell oropharyngeal cancer. The approach involves determining a tumor boost dose through mid-treatment imaging, allowing for a total dose of 80 Gy to be delivered via hybrid hyperfractionation. This method aims to minimize damage to critical normal tissues while enhancing locoregional control of the cancer. The study combines proton therapy with standard chemotherapy to improve treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with biopsy-proven HPV-negative squamous cell carcinoma of the oropharynx who have locally advanced disease.
Not a fit: Patients who have undergone definitive resection of their primary tumor will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes and reduced side effects for patients with advanced head and neck cancer.
How similar studies have performed: Other studies have shown promise with similar approaches using proton therapy and hyperfractionation, but this specific methodology is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: * Biopsy proven diagnosis of squamous cell carcinoma originating in the oropharynx. * Routine staging procedures, including CT of the head and neck region and chest, head and neck FDG-PET/CT and MRI (treatment planning allowed), and endoscopic evaluation when indicated. * Negative for p16 * Locally advanced disease, specifically meeting all following criteria: * Stage III-IV * T-stage 2-4 * All N-stages (N0-3) * M0 * Eligible for primary concurrent chemoradiation using conventionally fractionated radiotherapy 70 Gy combined with weekly cisplatin * Eastern Cooperative Oncology Group (ECOG) performance score ≥2 * Age ≥18 years * Written informed consent Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study; patients that: * underwent definitive resection of their primary tumor or nodal disease, except for incisional or excisional biopsies. received radiation therapy in the head and neck area in the past * have no detectable tumor anymore at both the primary site and lymph nodes at week 4 in treatment, because there will not be a volume to boost. * are unable or unwilling to give written, informed consent * have contra-indications for chemotherapy. This is at the discretion of the treating medical oncologist. * are unable to tolerate intravenous contrast for both CT and MRI, having an estimated GFR \< 60 ml/min/1.73 m2 or any contraindications to gadolinium-based contrast agents. * have any evidence of iron overload on pre-imaging laboratory studies. * have other serious illnesses or medical conditions present at entry in the study, including (but not limited to): immunodeficiency virus (HIV) infection or other conditions of persistent immunodeficiency, neurologic or psychiatric disorders, active disseminated intravascular coagulation, unstable cardiac disease despite treatment or uncontrolled diabetes mellitus. * Women who are pregnant or breast feeding
Where this trial is running
Groningen
- UMC Groningen — Groningen, Netherlands (Recruiting)
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.