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

Launched by UNIVERSITY MEDICAL CENTER GRONINGEN · May 31, 2024

Keywords

ClinConnect Summary

The PIRATES clinical trial is studying a new treatment method for patients with locally advanced oropharyngeal cancer, which is a type of head and neck cancer. Specifically, the trial is looking at the safety and feasibility of using a specialized form of radiation therapy called proton therapy, combined with chemotherapy, to see if giving higher doses in smaller amounts over time (a method known as hyper-fractionation) can be effective for patients who have HPV-negative squamous cell carcinoma. This research aims to improve treatment outcomes for patients dealing with this challenging condition.

To be eligible for this study, participants must be at least 18 years old and have a confirmed diagnosis of squamous cell carcinoma in the oropharynx. They should have advanced cancer that hasn't spread to other parts of the body, and they need to be candidates for standard treatment with chemotherapy and radiation. Those who have previously had surgery for their cancer, have no detectable tumor, or have certain health issues may not be able to participate. If enrolled, participants can expect to receive close monitoring during treatment to ensure their safety and to assess how well the therapy is working. This trial is currently recruiting participants, and signing up involves providing informed consent to ensure that everyone understands the study's purpose and procedures.

Gender

ALL

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