PIRATES: Image-guided Hyper-fractioned Dose-escalation With Proton Therapy for Head and Neck Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Image guided hybrid hyper-fractioned dose escalation with proton therapy.
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer, Oropharyngeal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Proton Image-guided Radiation Assignment for Therapeutic Escalation Via Selection of Locally Advanced Head and Neck Cancer Patients
Overview
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
Detailed description
For this study, the investigators propose a novel design to safely achieve tumor radiation dose escalation with proton therapy plus standard-of-care concomitant chemotherapy. Through mid-treatment image guidance, the tumor boost dose is determined; subsequently, only that GTV boost will receive a total dose of 80 Gy through hybrid hyperfractionation. This refers to twice-daily radiation in the last 15 fraction days. The combination of boost dose hyperfractionation and proton therapy is anticipated to prevent critical normal tissue damage within both the high- and intermediate-dose regions. This novel treatment approach aims to minimize critical toxicities while improving locoregional control for head and neck cancer patients who are at a higher risk of disease relapse.
Interventions
- Radiation Image guided hybrid hyper-fractioned dose escalation with proton therapy
Radiation: Image-guided hybrid hyper-fractioned dose escalation with proton therapy The investigational radiation regime will be administered in a two-part schedule: * The first 4 weeks (i.e. first 20 fractions) of the radiation treatment of the pathological tumor will be according to the conventional clinical standard with proton therapy: 20x 2 Gy to the CTV70 and 20 x 1.55 Gy to the CTV54. * In week 4 (\~ fraction 16) GTV80 will be determined on conventional weekly CT and additional MR imagi
Primary outcome measures
- Safety and feasibility [Time frame: Within 6 months after radiotherapy]
Secondary outcome measures (5)
- Completing radiotherapy regimen [Time frame: End of radiotherapy]
- Completing chemotherapy regimen [Time frame: End of chemotherapy]
- Toxicity after chemoradiation [Time frame: At 6 months after chemoradiation]
- Tumor response rate [Time frame: All SFP time points (baseline, weekly during RT, 6 weeks, 6, 12, 18, 24 months after treatment]
- Disease-free, overall survival and time-weighted locoregional control [Time frame: All SFP time points (baseline, weekly during RT, 6 weeks, 6, 12, 18, 24 months after treatment]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- UMC Groningen — Groningen
Identifiers
NCT: NCT06446713 · 18646