NCT05717166 A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.
| NCT ID | NCT05717166 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | David Palma |
| Condition | Metastatic Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2023-10-06 |
| Primary Completion | 2029-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 180 participants in total. It began in 2023-10-06 with a primary completion date of 2029-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05717166 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05717166 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 180 participants.
Is NCT05717166 currently recruiting?
Yes, NCT05717166 is actively recruiting participants. Contact the research team at David.Palma@lhsc.on.ca for enrollment information.
Where is the NCT05717166 trial being conducted?
This trial is being conducted at Prince George, Canada, Vancouver, Canada, London, Canada, Montreal, Canada and 1 additional location.
Who is sponsoring the NCT05717166 clinical trial?
NCT05717166 is sponsored by David Palma. The trial plans to enroll 180 participants.