PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy

Recruiting now · Phase 3

Conditions studied: Esophageal Cancer, Radiotherapy, Side Effect, Proton Therapy

In brief

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).

Key facts

Study ID: NCT05055648
Run by: University of Aarhus
People needed: 396
Starts: 2022-05-01
Expected to finish: 2032-12-01
Last updated by the study team: 2024-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Catholic University of Leuven — Leuven, Belgium (enrolling)
Aarhus University Hospital (AUH) — Aarhus, Denmark (enrolling)
Technische Universität Dresden (TUD) — Dresden, Germany (enrolling)
San Raffaele Hospital — Milan, Italy (enrolling)
Centro Nazionale di Adroterapia Oncologica (CNAO) — Pavia, Italy (enrolling)
Azienda Provinciale Per I Servizi Sanitari (APSS) — Trento, Italy (enrolling)
Paul Scherrer Institute (PSI) — Villigen, Switzerland (enrolling)
University Hospital Zurich (USZ) — Zurich, Switzerland (enrolling)
The Christie NHS foundation trust — Manchester, United Kingdom
Centre Léon Bérard (CLB) — Lyon, France
Centre Antoine Lacassagne (CAL) — Nice, France
Institut Curie — Paris, France
Academisch Ziekenhuis Groningen (UMCG) — Groningen, Netherlands
Stichting Maastricht Radiation Oncology (MAASTRO) — Maastricht, Netherlands
University College London Hospital (UCLH) — London, United Kingdom

Full record on ClinicalTrials.gov

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