Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06446713

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

Led by University Medical Center Groningen · Updated on 2025-04-03

17

Participants Needed

1

Research Sites

191 weeks

Total Duration

On this page

Sponsors

U

University Medical Center Groningen

Lead Sponsor

M

M.D. Anderson Cancer Center

Collaborating Sponsor

AI-Summary

What this Trial Is 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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Biopsy proven diagnosis of squamous cell carcinoma originating in the oropharynx.
  • Routine staging procedures including CT of the head and neck, chest, FDG-PET/CT, MRI, and endoscopic evaluation when indicated.
  • Negative for p16.
  • Locally advanced disease: Stage III-IV, T-stage 2-4, any N-stage (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 or older.
  • Written informed consent.
Not Eligible

You will not qualify if you...

  • Underwent definitive resection of primary tumor or nodal disease, except for biopsies.
  • Previous radiation therapy in the head and neck area.
  • No detectable tumor at primary site and lymph nodes at week 4 of treatment.
  • Unable or unwilling to give written informed consent.
  • Contraindications for chemotherapy as determined by the treating oncologist.
  • Unable to tolerate intravenous contrast for CT and MRI (e.g., estimated GFR < 60 ml/min/1.73 m2) or contraindications to gadolinium-based contrast agents.
  • Evidence of iron overload on pre-imaging laboratory studies.
  • Serious illnesses or medical conditions such as HIV infection, neurologic or psychiatric disorders, active disseminated intravascular coagulation, unstable cardiac disease despite treatment, or uncontrolled diabetes mellitus.
  • Pregnant or breastfeeding women.

AI-Screening

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Trial Site Locations

Total: 1 location

1

UMC Groningen

Groningen, Netherlands

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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