Stereotactic Ablative Radiotherapy for Patients with Oligometastases and a Primary Tumor
A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.
This study is testing if adding a special type of targeted radiation therapy to standard treatment can help people with a primary tumor and a few metastases feel better and live longer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Drugs / interventions | radiation |
| Locations | 5 sites (Prince George, British Columbia and 4 other locations) |
| Trial ID | NCT05717166 on ClinicalTrials.gov |
What this trial studies
This phase III multi-institutional randomized trial aims to evaluate the effectiveness of stereotactic ablative radiotherapy (SABR) in patients with up to 10 oligometastases alongside a synchronous primary tumor. Participants will be randomly assigned to receive either standard care treatment or standard care plus SABR, with stratification based on histology and the number of metastases. The study seeks to determine if the addition of SABR improves outcomes for these patients compared to standard treatment alone.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed malignancy, presenting with 1 to 10 metastases and a primary tumor.
Not a fit: Patients with serious medical comorbidities or those with more than 10 lifetime metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment outcomes for patients with oligometastatic cancer by potentially improving survival rates and quality of life.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Prince George, British Columbia and 4 other locations
- BC Cancer - Centre for the North — Prince George, British Columbia, Canada (Not_yet_recruiting)
- BC Cancer - Vancouver — Vancouver, British Columbia, Canada (Recruiting)
- London Regional Cancer Program of the Lawson Health Research Institute — London, Ontario, Canada (Recruiting)
- Centre Hospitalier de l'Université de Montréal-CHUM — Montreal, Quebec, Canada (Recruiting)
- Universitätsspital Zürich — Zurich, Switzerland (Recruiting)
Study contacts
- Study coordinator: David Palma, MD, PhD
- Email: David.Palma@lhsc.on.ca
- Phone: 519-685-8650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.