PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy

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).

Conditions

• Esophageal Cancer
• Radiotherapy
• Side Effect
• Proton Therapy

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

Sponsors & Collaborators

• University of Leeds

  collaborator OTHER

• KU Leuven

  collaborator OTHER

• University College, London

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Technische Universität Dresden

  collaborator OTHER

• Academisch Ziekenhuis Groningen

  collaborator OTHER

• CNAO National Center of Oncological Hadrontherapy

  collaborator OTHER

• Agenzia Nazionale per i Servizi Sanitari Regionali

  collaborator OTHER

• Centre Antoine Lacassagne

  collaborator OTHER

• Centre Leon Berard

  collaborator OTHER

• Institut Curie

  collaborator OTHER

• Maastro Clinic, The Netherlands

  collaborator OTHER

• University College London Hospitals

  collaborator OTHER

• The Christie NHS Foundation Trust

  collaborator OTHER

• Paul Scherrer Institut, Center for Proton Therapy

  collaborator OTHER

• HollandPTC

  collaborator INDUSTRY

• IBA worldwide

  collaborator UNKNOWN

• Varian- A Siemens Healthineer Company

  collaborator UNKNOWN

• University of Aarhus

  lead OTHER

Principal Investigators

• Marianne Nordsmark, Dr. · University of Aarhus

• Karin Haustermans, Dr. · UKleuven

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-01

Primary Completion

2027-12-01

Completion

2032-12-01

Countries

• Belgium
• Denmark
• France
• Germany
• Italy
• Netherlands
• Switzerland
• United Kingdom

Study Locations