Health Trials

Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE)

ConditionsGynecologic CancerSkin CancerHead and Neck CancerSarcomaRenal CancerBladder CancerUpper Urinary Tract CarcinomaPancreatic CancerHepatobiliary CancerGastric CancerSmall Bowel CancerEsophageal CancerMelanomaColon CancerOligometastasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC

About this trial

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.

Eligibility criteria

Qualifiers

Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.

at least 3 months since original tumour treated definitively, with no progression at primary site

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

Disqualifiers

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.

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

Trial design

Treatments tested in this trial

  • Stereotactic body radiotherapy
  • Palliative RT

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

European Organisation for Research and Treatment of Cancer - EORTC

Lead sponsor

Anticancer Fund, Belgium

Collaborator

Rising Tide Foundation

Collaborator

Source ClinicalTrials.gov