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NCT04498767Recrutement en cours

Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE)

Résumé

This is a randomized open-label multicentre Phase III superiority study of the effect of adding SBRT to the standard of care treatment on overall survival in patients with rare oligometastatic cancers. Patients will be randomized in a 1:1 ratio between current standard of care treatment vs. standard of care treatment + SBRT to all sites of known metastatic disease. The primary objective of this trial is to assess if the addition of stereotactic body radiotherapy (SBRT) to standard of care treatment improves overall survival (OS) as compared to standard of care treatment alone in patients with rare oligometastatic cancers.

Critères d'inclusion

• Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required. • Controlled primary tumour, defined as: • at least 3 months since original tumour treated definitively, with no progression at primary site • Total number of oligometastases of 1-5 including: • Brain metastases amenable to radiosurgery or fractionated stereotactic radiotherapy patient who had neurosurgical resection before trial inclusion are allowed and resected brain metastases count to the total number of oligometastases • All sites of disease can be safely treated based on the judgement of an experienced radiation oncologist • ECOG score 0-2 • Life expectancy \> 6 months • Age 18 or older • Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.

Critères d'exclusion

• Primary cancer of prostate, breast, lung or colorectal • Serious medical comorbidities precluding radiotherapy: • These include interstitial lung disease in patients requiring thoracic radiation, Crohn's disease in patients where the GI tract will receive radiotherapy, or ulcerative colitis where the bowel will receive radiotherapy and connective tissue disorders such as lupus or scleroderma. • For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or C) • Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated previously with radiation, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed in the RTQA Guidelines. All such cases should be discussed with one of the study coordinators • Brain metastases only, without extra-cerebral metastases • Malignant pleural effusion, malignant ascites, meningeal carcinomatosis and peritoneal carcinomatosis • Maximum size of 6 cm for lesions outside the brain, except: • Bone metastases over 5 cm may be included, if in the opinion of the local radiation oncologist it can be treated safely (e.g. rib, scapula, pelvis) • Clinical or radiologic evidence of symptomatic spinal cord compression. Patients can be eligible if surgical resection has been performed, but the surgical site counts toward the total of up to 3 metastases. • Metastatic disease that invades any of the following: GI tract (including oesophagus, stomach, small or large bowel), mesenteric lymph nodes, or disseminated skin metastases and lymphangiosis • Pregnant or breast feeding women • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial

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
Sans phase (N/A)
Type d'étude
Interventionnelle
Pays
Suisse, France, Allemagne, Italie, Belgique, Pologne, Royaume-Uni
Promoteur
European Organisation for Research and Treatment of Cancer - EORTC(Réseau / coopérateur)
N° de protocole
EORTC 1945
Pathologies
Gynecologic Cancer, Skin Cancer, Head and Neck Cancer, Sarcoma, Renal Cancer, Bladder Cancer, Upper Urinary Tract Carcinoma, Pancreatic Cancer, Hepatobiliary Cancer, Gastric Cancer, Small Bowel Cancer, Esophageal Cancer, Melanoma, Colon Cancer, Oligometastasis
Interventions
Radiothérapie

Traitements évalués

  • Stereotactic body radiotherapy
  • Palliative RT

Collaborateurs

Anticancer Fund, Belgium, Rising Tide Foundation

Lieux · 13

  • Bern, SuisseInselspitalRecrute dans ce centre
  • Zurich, SuisseUniversitaetsSpital ZurichRecrute dans ce centre
  • Lille, FranceCentre Oscar LambretRecrute dans ce centre
  • Villejuif, FranceGustave RoussyRecrute dans ce centre
  • Hamburg, AllemagneUniversitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer CenterRecrute dans ce centre
  • Milan, ItalieIstituto Europeo di OncologiaRecrute dans ce centre
  • Anderlecht, BelgiqueInstitut Jules BordetRecrute dans ce centre
  • Ghent, BelgiqueUniversitair Ziekenhuis GentRecrute dans ce centre
  • Wilrijk, BelgiqueGasthuiszusters Antwerpen - Sint-AugustinusRecrute dans ce centre
  • Gdansk, PologneMedical University Of GdanskRecrute dans ce centre
  • Warsaw, PologneMaria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of OncologyRecrute dans ce centre
  • Birmingham, Royaume-UniUniversity Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical CentreRecrute dans ce centre
  • London, Royaume-UniRoyal Marsden Hospital - site: Chelsea, LondonRecrute dans ce centre

Au total, dans le monde, les 13 centres listés au registre recrutent.

Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 26 août 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.