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Un essai de phase iii randomisé de radiothérapie ablatrice stéréotaxique pour les patients atteints d'un maximum de 10 oligométastases et d'une tumeur primitive synchrone. (SABR-SYNC)

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L'essai clinique NCT05717166 (SABR-SYNC) est conçu pour étudier le treatment de Tumeur métastatique. Il s'agit d'un essai interventionnel en Phase III. Son statut actuel est : en recrutement. L'essai a débuté le 6 octobre 2023 et vise à recruter 180 participants. Dirigé par David Palma, l'essai devrait être terminé d'ici le 1 avril 2029. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 29 avril 2025.
Résumé succinct
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).

Titre officiel

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

Conditions
Tumeur métastatique
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'essai
  • SABR-SYNC
  • ReDA 13176
Numéro NCT
NCT05717166
Date de début (réel)
2023-10-06
Dernière mise à jour publiée
2025-04-29
Date de fin (estimée)
2029-04
Inscription (estimée)
180
Type d'essai
Interventionnel
PHASE
Phase III
Statut
En recrutement
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
Comparateur actifStandard Arm (Arm 1)
Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications.
Radiothérapie palliative
Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Recommended dose fractionations in this arm will include 8 Gy in 1 fraction, 20 Gy in 5 fractions, and 30 Gy in 10 fractions.
Chimiothérapie
Pre-specified based on the standard of care approach for that patient.
Thérapie hormonale
Pre-specified based on the standard of care approach for that patient.
Immunothérapie
Pre-specified based on the standard of care approach for that patient.
Targeted Systemic Therapy
Pre-specified based on the standard of care approach for that patient.
Observation
Pre-specified based on the standard of care approach for that patient.
ExpérimentalExperimental Arm (Arm 2)
Consists of treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable (e.g. surgery, RFA, fractionated radiation, chemoradiation) if those are deemed to be preferable by the treating oncologists.
Radiothérapie palliative
Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Recommended dose fractionations in this arm will include 8 Gy in 1 fraction, 20 Gy in 5 fractions, and 30 Gy in 10 fractions.
Chimiothérapie
Pre-specified based on the standard of care approach for that patient.
Thérapie hormonale
Pre-specified based on the standard of care approach for that patient.
Immunothérapie
Pre-specified based on the standard of care approach for that patient.
Targeted Systemic Therapy
Pre-specified based on the standard of care approach for that patient.
Observation
Pre-specified based on the standard of care approach for that patient.
Radiothérapie ablative stéréotaxique
The primary tumor may be treated with SABR or with other local modalities at the discretion of the treating team and/or the local multidisciplinary tumor board. Preferred doses are 20 Gy in 1 fraction, 30 Gy in 3 fractions (every second day), and 35 Gy in 5 fractions (daily).
Chirurgie
Treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable if those are deemed to be preferable by the treating oncologists. The primary tumor may be treated with SABR or with other local modalities at the discretion of the treating team and/or the local multidisciplinary tumor board. Because of the convenience in using SABR for all lesions, non-SABR modalities should only be used if they are likely to provide a benefit over SABR.
Radiofrequency Therapy (RFA)
Treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable if those are deemed to be preferable by the treating oncologists.
Fractionated Radiation
Treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable if those are deemed to be preferable by the treating oncologists. Tumors in the esophagus, stomach, small intestine or colon should be treated with either fractionated radiation or a lower SABR dose (e.g. 25 Gy in 5 fractions) to minimize the risk of perforation.
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Overall Survival
Time from randomization to death from any cause, or date of last follow-up, whichever occurs first.
Approximately end of year 6 (Study Completion)
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
Quality of Life (QOL) assessed with the Functional Assessment of Cancer Therapy: General (FACT-G).
Quality of Life outcomes to be collected for the first 2 years (3, 6, 12, 18, 24 months)
Quality of Life (QOL) assessed with the Functional Assessment of Cancer Therapy: The EuroQol 5-Dimension 5-Level (EQ-5D-5L).
Quality of Life outcomes to be collected for the first 2 years (3, 6, 12, 18, 24 months)
Toxicity assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5 for each organ treated (e.g. liver, lung, bone).
Toxicity outcomes to be collected for the first 2 years (Last week of treatment, in 6 weeks, in 3, 6, 12, 18, 24 months)
Time to next systemic therapy
The time from randomization until commencement of any systemic anti-cancer therapy, or date of last follow-up, whichever occurs first.
From randomization to year 6 (study completion).
Receipt of additional radiation during follow-up
Will be collected for SABR (as a binary endpoint; yes/no), and non-SABR (yes/no).
During year 6 (follow-up year).
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  • 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

  • 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
David Palma logoDavid Palma
Partie responsable de l'essai
David Palma, Promoteur-Investigateur, Principal Investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Contact central de l'essai
Contact: David Palma, MD, PhD, 519-685-8650, [email protected]
4 Centres de l'essai dans 1 pays

British Columbia

BC Cancer - Centre for the North, Prince George, British Columbia, V2M 7E9, Canada
Robert Olson, MD, MSc, Investigateur principal
Pas encore en recrutement
BC Cancer - Vancouver, Vancouver, British Columbia, V5Z 4C2, Canada
Srinivas Raman, MD, Contact, 604-877-6000, [email protected]
Srinivas Raman, MD, Investigateur principal
En recrutement

Ontario

London Regional Cancer Program of the Lawson Health Research Institute, London, Ontario, N6A 5W9, Canada
David Palma, MD, PhD, Contact, 519-685-8650, [email protected]
David Palma, MD, PhD, Investigateur principal
En recrutement

Quebec

Centre Hospitalier de l'Université de Montréal-CHUM, Montreal, Quebec, H2X 0C1, Canada
Toni Vu, Contact, 514-575-7690, [email protected]
Toni Vu, MD, FRCP (C), Investigateur principal
En recrutement