NCT04498767

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

Stereotactic Body Radiotherapy in Addition to Standard of Care Treatment in Patients With Rare Oligometastatic Cancers (OligoRARE): a Randomized, Phase 3, Open-label Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gynecologic Cancer
• Skin Cancer
• Head and Neck Cancer
• Sarcoma
• Renal Cancer
• Bladder Cancer
• Upper Urinary Tract Carcinoma
• Pancreatic Cancer
• Hepatobiliary Cancer
• Gastric Cancer
• Small Bowel Cancer
• Esophageal Cancer
• Melanoma
• Colon Cancer
• Oligometastasis

Interventions

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

Timeline

• Start date: 2021-06-10
• Primary completion: 2028-08-01
• Completion: 2030-02-01
• First posted: 2020-08-04
• Last updated: 2024-08-26

Locations

13 sites across 7 countries: Belgium, France, Germany, Italy, Poland, Switzerland, United Kingdom