RecruitingPhase 3NCT05055648

PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy

PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy (PROTECT) a Multicenter International Randomized Phase III Study of Neoadjuvant Proton Versus Photon Chemoradiotherapy in Locally Advanced Esophageal Cancer


Sponsor

University of Aarhus

Enrollment

396 participants

Start Date

May 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares proton therapy versus conventional photon (X-ray) radiation in people with esophageal cancer who are being treated with chemotherapy plus radiation before surgery. Both are types of radiation; proton therapy is more targeted and may reduce side effects to the heart and lungs. **You may be eligible if...** - You are 18 or older with histologically confirmed esophageal or gastroesophageal junction cancer (squamous cell or adenocarcinoma) - Your cancer has not spread to distant organs (M0) - You are being considered for curative treatment (chemotherapy + radiation followed by surgery) - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to distant organs (M1) - You are not able to tolerate surgery or the combined treatment approach - Your blood counts or organ function are too low - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONPhoton Radiotherapy

nCXT 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

RADIATIONProton Radiotherapy

nCPT 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


Locations(15)

Catholic University of Leuven

Leuven, Belgium

Aarhus University Hospital (AUH)

Aarhus, Denmark

Centre Léon Bérard (CLB)

Lyon, France

Centre Antoine Lacassagne (CAL)

Nice, France

Institut Curie

Paris, France

Technische Universität Dresden (TUD)

Dresden, Germany

San Raffaele Hospital

Milan, Italy

Centro Nazionale di Adroterapia Oncologica (CNAO)

Pavia, Italy

Azienda Provinciale Per I Servizi Sanitari (APSS)

Trento, Italy

Academisch Ziekenhuis Groningen (UMCG)

Groningen, Netherlands

Stichting Maastricht Radiation Oncology (MAASTRO)

Maastricht, Netherlands

Paul Scherrer Institute (PSI)

Villigen, Switzerland

University Hospital Zurich (USZ)

Zurich, Switzerland

University College London Hospital (UCLH)

London, United Kingdom

The Christie NHS foundation trust

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05055648


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