RecruitingNot ApplicableNCT04498767

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

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrollment

200 participants

Start Date

Jun 10, 2021

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests high-precision, focused radiation therapy (called stereotactic body radiotherapy, or SBRT) for people with rare cancers that have spread to a small number of sites (called oligometastatic disease). The goal is to see if this targeted approach can control the cancer while preserving quality of life. **You may be eligible if...** - You have a rare cancer that has spread to a limited number of spots (oligometastatic) - Your original tumor site has been controlled for at least 3 months - You have no more than 5 sites of spread that can be safely treated with radiation - You are 18 or older and in reasonable overall health **You may NOT be eligible if...** - You have widespread cancer spread throughout your body - Your primary tumor is still actively progressing - You have had prior radiation to the exact areas that need treatment - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic 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.

RADIATIONPalliative 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).

Locations(13)

Institut Jules Bordet

Anderlecht, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Gasthuiszusters Antwerpen - Sint-Augustinus

Wilrijk, Belgium

Centre Oscar Lambret

Lille, France

Gustave Roussy

Villejuif, France

Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center

Hamburg, Martinistrasse 52, Germany

Istituto Europeo di Oncologia

Milan, Italy

Medical University Of Gdansk

Gdansk, Mariana Smoluchowskiego 17, Poland

Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology

Warsaw, Poland

Inselspital

Bern, Switzerland

UniversitaetsSpital Zurich

Zurich, Switzerland

University Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical Centre

Birmingham, United Kingdom

Royal Marsden Hospital - site: Chelsea, London

London, United Kingdom

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