Clinical trial NCT05717166: A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.
Official title: A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Metastatic Tumor
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \&gt; 60
* Life expectancy \&gt; 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 \&gt; 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

Primary outcomes:
measure: Overall Survival
timeFrame: Approximately end of year 6 (Study Completion)
Secondary outcomes:
measure: Quality of Life (QOL) assessed with the Functional Assessment of Cancer Therapy: General (FACT-G).
timeFrame: Quality of Life outcomes to be collected for the first 2 years (3, 6, 12, 18, 24 months)
measure: Quality of Life (QOL) assessed with the Functional Assessment of Cancer Therapy: The EuroQol 5-Dimension 5-Level (EQ-5D-5L).
timeFrame: Quality of Life outcomes to be collected for the first 2 years (3, 6, 12, 18, 24 months)
measure: Toxicity assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5 for each organ treated (e.g. liver, lung, bone).
timeFrame: Toxicity outcomes to be collected for the first 2 years (Last week of treatment, in 6 weeks, in 3, 6, 12, 18, 24 months)
measure: Time to next systemic therapy
timeFrame: From randomization to year 6 (study completion).
measure: Receipt of additional radiation during follow-up
timeFrame: During year 6 (follow-up year).
Other outcomes:
Locations:
city: Prince George
country: Canada
facility: BC Cancer - Centre for the North
state: British Columbia
city: Vancouver
country: Canada
facility: BC Cancer - Vancouver
state: British Columbia
city: London
country: Canada
facility: London Regional Cancer Program of the Lawson Health Research Institute
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier de l&#39;Université de Montréal-CHUM
state: Quebec
Study officials:
References: