NCT05055648Recruiting
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).
Inclusion criteria
• 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. • Performance status WHO ≤2. • Adequate laboratory findings: hematological: hemoglobin \> 90 g/L, absolute neutrophil count (ANC) ≥ 1,5 x 109/L, platelets ≥ 75 x 109/L hepatic: bilirubin ≤ 1.5 x upper limit of normal (ULN), ALAT ≤ 3 x ULN renal: creatinine ≤ 1.5 x ULN, GFR (may be calculated) \> 30 ml/min • MDT decision on suitability to undergo curatively intended nCXT or nCPT followed by surgery. • Planned transthoracic esophagectomy or gastrectomy being open, minimally invasive of combination of both. • Ability to adhere to procedures for study and follow-up. • Patients with low risk cancers with a life expectancy above 5 years (e.g. low risk prostate cancer) are allowed in the study. Adequately treated diagnoses such as cervix uteri carcinoma in situ, in situ urothelial carcinoma or localized non-melanoma skin cancer are allowed, regardless of time of diagnosis. • Patients of childbearing potential: pregnancy prevention according to the standards of each country. Patients of childbearing potential must present a negative pregnancy test. Patients and their partners must use effective contraception. Patients of childbearing potential included in the study must use oral contraceptives, intrauterine devices, depot injection of progestin subdermal implantation, a hormonal vaginal ring, or transdermal patch during the study treatment and one month after.
Exclusion criteria
Patients who meet one or more of the following exclusion criteria cannot be included in the study: • 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. • Any unstable systemic disease (including clinically significant lung and cardiovascular disease, unstable angina, New York Heart Association (NYHA) grade III-IV congestive heart, severe hepatic, renal or metabolic disease or active inflammatory bowel disease). • Symptomatic peripheral neuropathy greater than grade 1 (scored according to CTCAE v5.0). • Any other serious or uncontrolled illness, which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial. • Unable to understand and digest study patient information or comply with study treatment and safety instructions. • Gastro-esophageal stent within the irradiated volume.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Belgium, Denmark, Netherlands, United Kingdom
- Sponsor
- University of Aarhus(Other)
- Protocol no.
- DCPT101008134
- Conditions
- Esophageal Cancer, Radiotherapy, Side Effect, Proton Therapy
- Interventions
- Radiation
Treatments studied
- Photon Radiotherapy
- Proton Radiotherapy
Collaborators
University of Leeds, KU Leuven, University College, London, Aarhus University Hospital, Technische Universität Dresden, Academisch Ziekenhuis Groningen, CNAO National Center of Oncological Hadrontherapy, Agenzia Nazionale per i Servizi Sanitari Regionali, Centre Antoine Lacassagne, Centre Leon Berard, Institut Curie, Maastro Clinic, The Netherlands, University College London Hospitals, The Christie NHS Foundation Trust, Paul Scherrer Institut, Center for Proton Therapy, HollandPTC, IBA worldwide, Varian, a Siemens Healthineers Company
Locations · 8
- Villigen, SwitzerlandPaul Scherrer Institute (PSI)Recruiting at this site
- Zurich, SwitzerlandUniversity Hospital Zurich (USZ)Recruiting at this site
- Dresden, GermanyTechnische Universität Dresden (TUD)Recruiting at this site
- Milan, ItalySan Raffaele HospitalRecruiting at this site
- Pavia, ItalyCentro Nazionale di Adroterapia Oncologica (CNAO)Recruiting at this site
- Trento, ItalyAzienda Provinciale Per I Servizi Sanitari (APSS)Recruiting at this site
- Leuven, BelgiumCatholic University of LeuvenRecruiting at this site
- Aarhus, DenmarkAarhus University Hospital (AUH)Recruiting at this site
In total, worldwide, 8 of the 15 sites listed in the registry are recruiting; the other 7 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: December 17, 2024).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.