Actively Recruiting
PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy
Led by University of Aarhus · Updated on 2024-12-17
396
Participants Needed
15
Research Sites
552 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
U
University of Leeds
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastro-esophageal junction.
- FDG PET/CT scan must have been performed.
- Tumor stage should be cT1-4a and/or cN+, cM0 according to TNM 8th edition.
- Participants must be 18 years or older.
- Performance status must be WHO 2 or less.
- Laboratory results must meet minimum blood counts and organ function levels.
- Multidisciplinary team decision confirming suitability for curative neoadjuvant chemoradiotherapy and surgery.
- Planned transthoracic esophagectomy or gastrectomy via open, minimally invasive, or combined approach.
- Ability to comply with study procedures and follow-up.
- Patients with low-risk cancers with life expectancy over 5 years or adequately treated in situ carcinomas or localized skin cancer are allowed.
- Patients of childbearing potential must use effective contraception and have a negative pregnancy test before enrollment.
You will not qualify if you...
- Prior thoracic photon or proton radiation, chemotherapy, or surgery in the esophageal or gastric region (except prior EMR or ESD).
- Tumor located less than 3 cm from the oropharyngeal sphincter.
- Planned transhiatal resection surgery.
- Other previous malignancies unless complete remission or resection was achieved at least 5 years before.
- Unstable systemic diseases including significant lung, heart, liver, kidney, metabolic, or inflammatory bowel diseases.
- Symptomatic peripheral neuropathy greater than grade 1.
- Any serious or uncontrolled illness deemed unsuitable by the investigator.
- Inability to understand study information or comply with treatment and safety instructions.
- Presence of gastro-esophageal stent within the radiation field.
AI-Screening
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Trial Site Locations
Total: 15 locations
1
Catholic University of Leuven
Leuven, Belgium
Actively Recruiting
2
Aarhus University Hospital (AUH)
Aarhus, Denmark, 8000
Actively Recruiting
3
Centre Léon Bérard (CLB)
Lyon, France
Not Yet Recruiting
4
Centre Antoine Lacassagne (CAL)
Nice, France
Not Yet Recruiting
5
Institut Curie
Paris, France
Not Yet Recruiting
6
Technische Universität Dresden (TUD)
Dresden, Germany
Actively Recruiting
7
San Raffaele Hospital
Milan, Italy
Actively Recruiting
8
Centro Nazionale di Adroterapia Oncologica (CNAO)
Pavia, Italy
Actively Recruiting
9
Azienda Provinciale Per I Servizi Sanitari (APSS)
Trento, Italy
Actively Recruiting
10
Academisch Ziekenhuis Groningen (UMCG)
Groningen, Netherlands
Withdrawn
11
Stichting Maastricht Radiation Oncology (MAASTRO)
Maastricht, Netherlands
Withdrawn
12
Paul Scherrer Institute (PSI)
Villigen, Switzerland
Actively Recruiting
13
University Hospital Zurich (USZ)
Zurich, Switzerland, 8091
Actively Recruiting
14
University College London Hospital (UCLH)
London, United Kingdom
Withdrawn
15
The Christie NHS foundation trust
Manchester, United Kingdom
Not Yet Recruiting
Research Team
D
Dorte Winter
CONTACT
T
Toke Hansen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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