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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Photon Radiotherapy
RadiationnCXT consists of weekly carboplatin and paclitaxel for 5 weeks, following the CROSS trial. The radiation dose will be either 41.4 Gy in 23 fractions or 50.4 Gy in 28 fractions
Proton Radiotherapy
RadiationnCPT consists of weekly carboplatin and paclitaxel for 5 weeks, following the CROSS trial. The radiation dose will be either 41.4 Gy in 23 fractions or 50.4 Gy in 28 fractions
Treatment groups
396 Participants
are divided into 2 treatment groupsGroup A: Photon ArmActive comparator 1 intervention
Group B: Proton ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pulmonary complications
Incidence of pulmonary complications during and following nCPT or nCXT and surgery
Time frame
from randomization until 90 days after surgerySecondary outcomes
1
Early toxicity
Predefined items ≥ grade 2 scored by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame
from start of nCPT or nCXT until surgery2
Late toxicity
Predefined items ≥ grade 2 scored by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame
up to 5 years3
Postoperative complications
Predefined items scored by Clavien-Dindo and Comprehensive Complications Index (CCI)
Time frame
from surgery until 90 days after surgery4
Major cardiovascular events (MACE)
Predefined cardiovascular events scored by MACE
Time frame
up to 5 yearsOther outcomes
1
Total toxicity burden (TTB)
The combined toxicity scale TTB used in the trial by Lin et al (Lin 2020)
Time frame
from randomization until 90 days after surgery2
Concordance of observed pulmonary complications with predicted complications from NTCP models
Comparison of observed and predicted toxicity rates
Time frame
up to 5 years3
Blood biomarkers as predictors for treatment failure
circulating tumor DNA
Time frame
up to 5 years4
Proportion of patients receiving adjuvant immunotherapy
The actual number of patients starting adjuvant immunotherapy will be recorded
Time frame
up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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