NCT05784428 Single vs. Multiple Fraction Trial of Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastases/Progression
| NCT ID | NCT05784428 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Robert Olson |
| Condition | Oligometastatic Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 598 participants |
| Start Date | 2025-04-16 |
| Primary Completion | 2035-04-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Stereotactic Ablative Radiotherapy (SABR) is a modern RT technique that delivers high doses of radiation to small tumor targets using highly conformal techniques, while trying to avoid healthy tissues and organs. However, SABR treatment requires increased planning, treatment time, cost and potential for higher toxicity due to the higher dose. The purpose of this study is to compare single fraction (SF) SABR vs. multiple fraction (MF) SABR in regards to toxicities, progression-free survival, quality of life (QoL), and cost-effectiveness. In a subset of patients, we will also compare patient QoL, hospitalization rates, and cost-effectiveness between patients who complete QoL questionnaires, record symptoms and receive healthcare provider-guided intervention vs. patients who complete QoL questionnaires only.
Eligibility Criteria
Inclusion Criteria: * 1-5 current oligometastatic or oligo-progressive lesions * Age 18 years or older * Able to provide informed consent * Able to complete electronic entry of patient reported outcomes and questionnaires independently or with assistance from a caregiver/family/friend/research staff using electronic methods after providing consent to email use. * Life expectancy \> 6 months * Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Controlled primary tumor: defined as at least 3 months since original tumor treated radically, with no progression at primary site (can be considered controlled if no evidence of the primary tumour on imaging \[e.g. primary unknown\]) * A history and physical examination, including ECOG performance status, performed within 6 weeks prior to enrollment * Patient has had a CT chest, abdomen and pelvis