NCT06446713RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 3 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (estimated)
- First submitted
- 31 May 2024
- Start date
- 1 May 2025
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- University Medical Center Groningen
- Diseases
- Head and neck cancer
- NCT number
- NCT06446713
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 17
- From 1 May 2025 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 contra-indications for chemotherapy. This is at the discretion of the treating medical oncologist.
Other illness
- 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.
Lab values
- 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.
Other
- A potential subject who meets any of the following criteria will be excluded from participation in this study; patients that:
- 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
- Women who are pregnant or breast feeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UMC Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.