At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed metastatic malignancy
- ✓Controlled primary tumor with at least 3 months since definitive treatment and no progression
- ✓Total of 1-5 oligometastases
- ✓Brain metastases amenable to radiosurgery or stereotactic radiotherapy allowed, including resected ones
- ✕Primary cancer of prostate, breast, lung, or colorectal
- ✕Serious comorbidities precluding radiotherapy including interstitial lung disease, Crohn's disease, ulcerative colitis, lupus, or scleroderma
- ✕Moderate to severe liver dysfunction (Child Pugh B or C) in patients with liver metastases
- ✕Substantial overlap with previously treated radiation volume
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Stereotactic Body Radiotherapy in Addition to Standard of Care Treatment in Patients With Rare Oligometastatic Cancers (OligoRARE): a Randomized, Phase 3, Open-label Trial
In Brief
A clinical study evaluating Stereotactic body radiotherapy and Palliative RT for Gynecologic Cancer and 14 related conditions. Currently recruiting, targeting 200 participants across 13 sites in 7 countries.
Signals
Detailed Summary
This is a randomized open-label multicentre Phase III superiority study of the effect of adding SBRT to the standard of care treatment on overall survival in patients with rare oligometastatic cancers. Patients will be randomized in a 1:1 ratio between current standard of care treatment vs. standard of care treatment + SBRT to all sites of known metastatic disease. The primary objective of this trial is to assess if the addition of stereotactic body radiotherapy (SBRT) to standard of care treatment improves overall survival (OS) as compared to standard of care treatment alone in patients with rare oligometastatic cancers.
Study Details
Timeline
Interventions
Each lesion may be treated with 1, 3, or 5 SBRT fractions of 16-24 Gy, 24-33 Gy or 25-40 Gy, respectively, depending on the local practice and size \& location of oligometastases. Three-fraction regimens will deliver a fraction every second day, and five-fraction regimens are delivered daily. All treatments must be completed within 2 weeks (10 working days) in order to avoid delays in starting systemic therapy.
Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Recommended dose fractionations in this arm will include 8 Gy in 1 fractions, 20 Gy in 5 fractions, and 30 Gy in 10 fractions. Patients in this arm should not receive stereotactic doses or radiotherapy boosts, unless there is a clearly known clinical benefit (e.g. stereotactic radiation to a new brain metastases when all disease is controlled on systemic therapy).