Tests stereotactic body radiotherapy added to standard care in rare cancers
Tests precise radiotherapy added to standard care in adults with rare cancers.
Key facts
- Who runs it
- European Organisation for Research and Treatment of Cancer - EORTC
- Where
- Gdansk and Warsaw, PolandSee the 2 sitesAlso in 6 other countries, 11 sites
- Trial code
- Registry title
- Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE)
- Status
- Recruiting
- People taking part
- 200 people, planned
- Started
- 10 Jun 2021
- Expected to end
- 1 Feb 2030
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Stereotactic body radiotherapy
- Palliative RT
- Record updated
- 26 August 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a rare cancer that has spread to 1 to 5 places, where the first tumour is under control. It tests adding focused radiotherapy (SBRT) to standard treatment.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Cancer confirmed by tissue examination that has spread to 1-5 sites (oligometastatic). The first tumour must be controlled: at least 3 months since it was treated definitively, with no progression at that site. All sites must be safely treatable with radiotherapy.
- Earlier treatment
- The original tumour must have been treated definitively at least 3 months before. Earlier radiotherapy is allowed if the combined plan meets dose limits. Brain metastases removed by surgery before joining are allowed and count in the total.
Main reasons for not taking part
- Primary cancer of the prostate, breast, lung or colorectum
- Brain metastases only, with no spread outside the brain
- Fluid from cancer in the chest or belly, meningeal or peritoneal carcinomatosis
- Lesions outside the brain larger than 6 cm (2.4 in) (bone lesions over 5 cm (2 in) only if they can be treated safely)
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- 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
Who cannot take part
- Serious medical comorbidities precluding radiotherapy:
- 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
- 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)
- Primary cancer of prostate, breast, lung or colorectal
- 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
- Malignant pleural effusion, malignant ascites, meningeal carcinomatosis and peritoneal carcinomatosis
- 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
- 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
- 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
- For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or C)
- Brain metastases only, without extra-cerebral metastases
- Maximum size of 6 cm for lesions outside the brain, except:
- Pregnant or breast feeding women
Where in Poland
Also in 6 other countries, 11 sites
- Medical University Of GdanskGdansk, PolandContact: EORTC HQTaking people
- Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of OncologyWarsaw, PolandContact: EORTC HQTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Arm 1: Standard of Care + palliative RTExisting treatment, for comparison
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). Systemic therapy will be pre-specified based on the standard of care approach for that patient, and it may include cytotoxic, targeted, hormonal, or immunotherapy.
Treatment: Palliative RT
- Arm 2: Standard of Care + SBRTTreatment being tested
The experimental arm consists of SBRT (and standard of care systemic therapy). 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. Patients treated with prior or concomitant systemic therapy are eligible for this study. Use of chemotherapy regimens, targeted therapy or immunotherapy containing potent enhancers of radiation damage (e.g. gemcitabine, doxorubicin) can be postponed or interrupted for a duration of one month after radiation.
Treatment: Stereotactic body radiotherapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Stereotactic Body Radiotherapy in Addition to Standard of Care Treatment in Patients With Rare Oligometastatic Cancers (OligoRARE): a Randomized, Phase 3, Open-label Trial
- Plain-language title
- Tests stereotactic body radiotherapy added to standard care in rare cancersGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 26 August 2024