Stereotactic Ablative Radiotherapy for Patients with Oligometastases and a Primary Tumor

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• BC Cancer - Centre for the North
  Prince George, British Columbia, Canada Not yet recruiting

Study contacts

• Study coordinator: David Palma, MD, PhD
• Email: David.Palma@lhsc.on.ca
• Phone: 519-685-8650

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.