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RECRUITING
NCT05055648
PHASE3

PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy

Sponsor: University of Aarhus

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

396

Start Date

2022-05-01

Completion Date

2032-12-01

Last Updated

2024-12-17

Healthy Volunteers

No

Interventions

RADIATION

Photon 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

RADIATION

Proton 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