Aller au contenu
Retour à la recherche

NCT05717166Recrutement en cours

A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.

Résumé

This study is a phase III multi-institutional randomized trial. Patients will be randomized in a 1:2 ratio between current standard of care treatment (Arm 1) vs. standard of care treatment + SABR (Arm 2) to sites of known disease. Patients will be stratified by two of the strongest prognostic factors, based on a large multi-institutional analysis3: histology (Group 1: hormone-sensitive prostate cancer, breast, or renal; Group 2: all others), and number of metastases (Group 1: 1-3; Group 2: 4-10).

Critères d'inclusion

• Age 18 years or older • Willing to provide informed consent • Karnofsky performance status \> 60 • Life expectancy \> 6 months • Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required. • Total number of metastases 1-10 at the time of enrollment, with a primary tumor also present • Restaging completed within 12 weeks prior to randomization (see section 5.1) • For patients receiving thoracic radiotherapy, the enrolling physician must confirm there are no computed tomography (CT) changes suggestive of fibrotic interstitial lung disease (ILD) (i.e. reticular changes, traction bronchiectasis, or honeycombing) reported on any prior CT scans. If any are present, the patient must be assessed by a respirologist to rule out ILD prior to enrollment. • 10 or fewer lifetime metastases from the cancer for which participants are being enrolled

Critères d'exclusion

• Serious medical comorbidities precluding radiotherapy. These include ILD in patients requiring thoracic radiation, Crohn's disease in patients where the gastrointestinal (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); please see the Child-Pugh score calculator. • 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 with radiation previously, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed in Appendix 1. All such cases must be discussed with a member of the study steering committee. • Malignant pleural effusion • Inability to treat all sites of disease • Brain metastasis \> 3 cm in size or a total volume of brain metastases greater than 30 cc. • Metastasis in the brainstem • Clinical or radiologic evidence of spinal cord compression • Metastatic disease that invades any of the following: GI tract (including esophagus, stomach, small or large bowel), or skin • Pregnant or lactating women

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, Canada
Promoteur
David Palma(Autre)
N° de protocole
ReDA 13176
Pathologies
Metastatic Tumor
Interventions
Radiothérapie, Médicament, Autre, Procédure

Traitements évalués

  • Palliative Radiotherapy
  • Chemotherapy
  • Hormone therapy
  • Immunotherapy
  • Targeted Systemic Therapy
  • Observation
  • Stereotactic Ablative Radiotherapy
  • Surgery
  • Radiofrequency Therapy (RFA)
  • Fractionated Radiation

Lieux · 4

  • Zurich, SuisseUniversitätsspital ZürichRecrute dans ce centre
  • Vancouver, CanadaBC Cancer - VancouverRecrute dans ce centre
  • London, CanadaLondon Regional Cancer Program of the Lawson Health Research InstituteRecrute dans ce centre
  • Montreal, CanadaCentre Hospitalier de l'Université de Montréal-CHUMRecrute dans ce centre

Au total, dans le monde, 4 des 5 centres listés au registre recrutent ; l'autre ne recrute pas actuellement.

Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 31 décembre 2025).

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.