Clinical trial · Interventional
PIRATES: Image-guided Hyper-fractioned Dose-escalation With Proton Therapy for Head and Neck Cancer
Proton Image-guided Radiation Assignment for Therapeutic Escalation Via Selection of Locally Advanced Head and Neck Cancer Patients
NCT06446713CI-TRIAL-00088049PIRATESrecruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this study the safety \& feasibility of image-guided mid-treatment hyper-fractioned dose-escalation with proton therapy will be assessed for the treatment of locally advanced HPV-negative squamous cell oropharyngeal cancer
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Oropharyngeal Cancer | Malignant Oropharyngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Image guided hybrid hyper-fractioned dose escalation with proton therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Image guided hybrid hyper-fractioned dose escalation with proton therapy
- interventionNames
- Radiation: Image guided hybrid hyper-fractioned dose escalation with proton therapy
Primary outcomes (1)
- measure
- Safety and feasibility
- timeFrame
- Within 6 months after radiotherapy
- description
- The number of dose limiting toxicity (DLT) events, defined as grade ≥4 mucositis, grade ≥4 ulceration, grade ≥4 dermatitis, grade ≥4 aspiration, grade ≥4 osteonecrosis and grade ≥3 myelopathy
Secondary outcomes (5)
- measure
- Completing radiotherapy regimen
- timeFrame
- End of radiotherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.