PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus
About this trial
The PROTECT trial will test the hypothesis that proton (PT) -enabled radiation dose reductions to sensitive, normal tissues will result in lower rates of treatment-related pulmonary complications in esophageal cancer compared to standard photon therapy (XT).
Eligibility criteria
Qualifiers
Patients with histologically verified squamous cell carcinoma or adenocarcinoma (including signet cell carcinoma and large cell carcinoma, not further specified) of the esophagus (E) or gastro-esophageal junction (GEJ).
FDG PET/CT performed.
Tumor stage according to TNM (8th edition): cT1-4a and/or cN+, cM0.
Age ≥18 years.
Disqualifiers
Prior thoracic XT or PT, chemotherapy or surgical resection in the esophageal/gastric region (previous EMR or ESD is allowed).
Tumor < 3 cm from oropharyngeal sphincter.
Planned transhiatal resection
Patients with other previous malignancies are excluded unless a complete remission or complete resection was achieved at least 5 years prior to study entry.
Trial design
Treatments tested in this trial
- Photon Radiotherapy
- Proton Radiotherapy
Treatment groups
396 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Aarhus
Lead sponsor
University of Leeds
Collaborator
KU Leuven
Collaborator
University College, London
Collaborator
Aarhus University Hospital
Collaborator
Technische Universität Dresden
Collaborator
Academisch Ziekenhuis Groningen
Collaborator
CNAO National Center of Oncological Hadrontherapy
Collaborator
Agenzia Nazionale per i Servizi Sanitari Regionali
Collaborator
Centre Antoine Lacassagne
Collaborator
Centre Leon Berard
Collaborator
Institut Curie
Collaborator
Maastro Clinic, The Netherlands
Collaborator
University College London Hospitals
Collaborator
The Christie NHS Foundation Trust
Collaborator
Paul Scherrer Institut, Center for Proton Therapy
Collaborator
HollandPTC
Collaborator
IBA worldwide
Collaborator
Varian- A Siemens Healthineer Company
Collaborator
Source ClinicalTrials.gov