PIRATES: Image-guided Hyper-fractioned Dose-escalation With Proton Therapy for Head and Neck Cancer

University Medical Center Groningen (UMCG)

Status and phase

Enrolling

Phase 1

Conditions

Oropharyngeal Cancer

Head and Neck Cancer

Treatments

Radiation: Image guided hybrid hyper-fractioned dose escalation with proton therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06446713

18646

Details and patient eligibility

About

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

Full 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.

Enrollment

17 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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