Status:
RECRUITING
Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE)
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Collaborating Sponsors:
Anticancer Fund, Belgium
Rising Tide Foundation
Conditions:
Gynecologic Cancer
Skin Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2030
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04498767
Start Date
June 10 2021
End Date
February 1 2030
Last Update
August 26 2024
Active Locations (13)
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1
Institut Jules Bordet
Anderlecht, Belgium, 1070
2
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
3
Gasthuiszusters Antwerpen - Sint-Augustinus
Wilrijk, Belgium, 2610
4
Centre Oscar Lambret
Lille, France, 59020