Using stereotactic body radiotherapy for patients with rare oligometastatic cancers
Stereotactic Body Radiotherapy in Addition to Standard of Care Treatment in Patients With Rare Oligometastatic Cancers (OligoRARE): a Randomized, Phase 3, Open-label Trial
This study is testing if adding a special type of targeted radiation therapy to standard treatment can help people with rare cancers that have spread to a few places live longer and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Organisation for Research and Treatment of Cancer - EORTC Research network |
| Drugs / interventions | radiation |
| Locations | 13 sites (Anderlecht and 12 other locations) |
| Trial ID | NCT04498767 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of adding stereotactic body radiotherapy (SBRT) to standard care in improving overall survival for patients with rare oligometastatic cancers. Participants will be randomly assigned to receive either standard treatment alone or standard treatment plus SBRT targeting all known metastatic sites. The study aims to determine if this combination can lead to better outcomes compared to standard care alone. It involves multiple centers and focuses on a specific group of patients with limited metastatic disease.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with histologically confirmed rare oligometastatic cancers and a controlled primary tumor.
Not a fit: Patients with primary cancers of the prostate, breast, lung, or colorectal, as well as those with serious medical comorbidities, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients with rare oligometastatic cancers.
How similar studies have performed: Other studies have shown promising results with SBRT in similar contexts, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required. * Controlled primary tumour, defined as: * at least 3 months since original tumour treated definitively, with no progression at primary site * Total number of oligometastases of 1-5 including: * Brain metastases amenable to radiosurgery or fractionated stereotactic radiotherapy patient who had neurosurgical resection before trial inclusion are allowed and resected brain metastases count to the total number of oligometastases * All sites of disease can be safely treated based on the judgement of an experienced radiation oncologist * ECOG score 0-2 * Life expectancy \> 6 months * Age 18 or older * Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations. Exclusion Criteria: * Primary cancer of prostate, breast, lung or colorectal * Serious medical comorbidities precluding radiotherapy: * These include interstitial lung disease in patients requiring thoracic radiation, Crohn's disease in patients where the 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) * 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 previously with radiation, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed in the RTQA Guidelines. All such cases should be discussed with one of the study coordinators * Brain metastases only, without extra-cerebral metastases * Malignant pleural effusion, malignant ascites, meningeal carcinomatosis and peritoneal carcinomatosis * Maximum size of 6 cm for lesions outside the brain, except: * Bone metastases over 5 cm may be included, if in the opinion of the local radiation oncologist it can be treated safely (e.g. rib, scapula, pelvis) * Clinical or radiologic evidence of symptomatic spinal cord compression. Patients can be eligible if surgical resection has been performed, but the surgical site counts toward the total of up to 3 metastases. * Metastatic disease that invades any of the following: GI tract (including oesophagus, stomach, small or large bowel), mesenteric lymph nodes, or disseminated skin metastases and lymphangiosis * Pregnant or breast feeding women * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial
Where this trial is running
Anderlecht and 12 other locations
- Institut Jules Bordet — Anderlecht, Belgium (Recruiting)
- Universitair Ziekenhuis Gent — Ghent, Belgium (Recruiting)
- Gasthuiszusters Antwerpen - Sint-Augustinus — Wilrijk, Belgium (Recruiting)
- Centre Oscar Lambret — Lille, France (Recruiting)
- Gustave Roussy — Villejuif, France (Recruiting)
- Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center — Hamburg, Martinistrasse 52, Germany (Recruiting)
- Istituto Europeo di Oncologia — Milan, Italy (Recruiting)
- Medical University Of Gdansk — Gdansk, Mariana Smoluchowskiego 17, Poland (Recruiting)
- Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology — Warsaw, Poland (Recruiting)
- Inselspital — Bern, Switzerland (Recruiting)
- UniversitaetsSpital Zurich — Zurich, Switzerland (Recruiting)
- University Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical Centre — Birmingham, United Kingdom (Recruiting)
- Royal Marsden Hospital - site: Chelsea, London — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Matthias Guckenberger — University of Zurich
- Study coordinator: Eortc Hq
- Email: eortc@eortc.org
- Phone: +32 2 7744 1611
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.