Actively Recruiting
Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE)
Led by European Organisation for Research and Treatment of Cancer - EORTC · Updated on 2024-08-26
200
Participants Needed
13
Research Sites
451 weeks
Total Duration
On this page
Sponsors
E
European Organisation for Research and Treatment of Cancer - EORTC
Lead Sponsor
A
Anticancer Fund, Belgium
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed cancer with metastatic disease seen on imaging; biopsy of metastases preferred but not required
- Controlled primary tumor with no progression at primary site for at least 3 months after definitive treatment
- Total of 1 to 5 oligometastases, including brain metastases treatable with radiosurgery or stereotactic radiotherapy
- All disease sites can be safely treated as judged by an experienced radiation oncologist
- ECOG performance status between 0 and 2
- Life expectancy greater than 6 months
- Age 18 years or older
- Written informed consent given before randomization according to regulations
You will not qualify if you...
- Primary cancer of prostate, breast, lung, or colorectal
- Serious medical conditions preventing radiotherapy, including interstitial lung disease requiring thoracic radiation, Crohn's disease if the GI tract will receive radiation, ulcerative colitis if bowel will receive radiation, and connective tissue disorders such as lupus or scleroderma
- Moderate or severe liver dysfunction (Child Pugh B or C) in patients with liver metastases
- Substantial overlap with previously treated radiation area that exceeds dose constraints
- Brain metastases only, without metastases outside the brain
- Presence of malignant pleural effusion, malignant ascites, meningeal carcinomatosis, or peritoneal carcinomatosis
- Lesions larger than 6 cm outside the brain except bone metastases over 5 cm if safely treatable
- Symptomatic spinal cord compression unless surgically treated; surgical sites count toward maximum metastases
- Metastases invading gastrointestinal tract, mesenteric lymph nodes, or widespread skin metastases with lymphangiosis
- Pregnant or breastfeeding women
- Psychological, familial, social, or geographic conditions that may interfere with study compliance and follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Institut Jules Bordet
Anderlecht, Belgium, 1070
Actively Recruiting
2
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
3
Gasthuiszusters Antwerpen - Sint-Augustinus
Wilrijk, Belgium, 2610
Actively Recruiting
4
Centre Oscar Lambret
Lille, France, 59020
Actively Recruiting
5
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
6
Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center
Hamburg, Martinistrasse 52, Germany, DE 20246
Actively Recruiting
7
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
8
Medical University Of Gdansk
Gdansk, Mariana Smoluchowskiego 17, Poland, PL 80-214
Actively Recruiting
9
Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Poland, PL 02 781
Actively Recruiting
10
Inselspital
Bern, Switzerland, 3010
Actively Recruiting
11
UniversitaetsSpital Zurich
Zurich, Switzerland, 8091
Actively Recruiting
12
University Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical Centre
Birmingham, United Kingdom, B15 2TH
Actively Recruiting
13
Royal Marsden Hospital - site: Chelsea, London
London, United Kingdom, SW3 6JJ
Actively Recruiting
Research Team
E
EORTC HQ
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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