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Vilon

KE, L-Lys-L-Glu, lysylglutamic acid

Quick Stats
Studies 40
Trials 100
Recruiting NA INTERVENTIONAL NCT04498767

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

View on ClinicalTrials.gov Updated Dec 15, 2025

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. 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.

Interventions

Name: Stereotactic body radiotherapy
Type: RADIATION
Description: 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.
Name: Palliative RT
Type: RADIATION
Description: 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).

Primary Outcomes

Measure: Overall survival
TimeFrame: 7.5 years from first patient in
Description: Overall survival is the time interval from the date of randomization to the date of death whatever the cause of death. Patients who are alive are censored at the last date known to be alive.

Trial Information

NCT ID

NCT04498767

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Last Updated

December 15, 2025