Informations générales (source: ClinicalTrials.gov)
Stereotactic Body Radiotherapy in Addition to Standard of Care Treatment in Patients With Rare Oligometastatic Cancers (OligoRARE): a Randomized, Phase 3, Open-label Trial
Interventional
N/A
European Organisation for Research and Treatment of Cancer - EORTC (Voir sur ClinicalTrials)
juin 2021
février 2030
15 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Antonin LEVY | 16/02/2024 10:55:55 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Oscar Lambret - 59020 - Lille - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
- 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.
- 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