Aller au contenu
Retour à la recherche

NCT05055648Recrutement en cours

PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy

Résumé

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).

Critères d'inclusion

• 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.

Critères d'exclusion

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

Les coordonnées de l'équipe de l'essai s'affichent sur demande.

Voir la fiche officielle de l'essai
Statut
Recrutement en cours
Phase
Phase 3
Type d'étude
Interventionnelle
Pays
Suisse, France, Allemagne, Italie, Belgique, Danemark, Pays-Bas, Royaume-Uni
Promoteur
University of Aarhus(Autre)
N° de protocole
DCPT101008134
Pathologies
Esophageal Cancer, Radiotherapy, Side Effect, Proton Therapy
Interventions
Radiothérapie

Traitements évalués

  • Photon Radiotherapy
  • Proton Radiotherapy

Collaborateurs

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

Lieux · 8

  • Villigen, SuissePaul Scherrer Institute (PSI)Recrute dans ce centre
  • Zurich, SuisseUniversity Hospital Zurich (USZ)Recrute dans ce centre
  • Dresden, AllemagneTechnische Universität Dresden (TUD)Recrute dans ce centre
  • Milan, ItalieSan Raffaele HospitalRecrute dans ce centre
  • Pavia, ItalieCentro Nazionale di Adroterapia Oncologica (CNAO)Recrute dans ce centre
  • Trento, ItalieAzienda Provinciale Per I Servizi Sanitari (APSS)Recrute dans ce centre
  • Leuven, BelgiqueCatholic University of LeuvenRecrute dans ce centre
  • Aarhus, DanemarkAarhus University Hospital (AUH)Recrute dans ce centre

Au total, dans le monde, 8 des 15 centres listés au registre recrutent ; les 7 autres ne recrutent pas actuellement.

Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 17 décembre 2024).

Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.

Voir aussi

Autres versions

Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.