RecruitingNot ApplicableNCT05102747

Stereotactic Radiotherapy in Oligometastatic Brain Disease: a Randomised Phase III Study Comparing Hypofractionated Stereotactic Radiation Therapy (3*10 Gy) to the Historical Single-dose Radiosurgery (1*20 to 25 Gy) With Medico-economic Evaluation.


Sponsor

Centre Francois Baclesse

Enrollment

504 participants

Start Date

Jan 12, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Brain metastases (BM) are a common systemic cancer manifestation which incidence increases. Therapeutic options include whole-brain radiotherapy (WBRT), surgery, and stereotactic radiosurgery (SRS). The concept of "oligometastatic" cerebral disease (oligoBM) has emerged and led to consider alternative approaches. The main challenge is to preserve neurological function and independence the longest as possible. Stereotactic radiotherapy (SRT) has emerged as an alternative treatment modality for selected oligoBM patients. It allows to achieve the balance of tumour destruction and normal tissue preservation by precisely and accurately delivering a very high dose of radiation in one (SRS) or a few (HSRT) fractions to a limited, well-defined volume. However, no standard exists for decision-making between SRS and HSRT and this important question is being discussed in the recent literature. HSRT appears particularly interesting, assuming the patient convenience of few fractions, the normal tissue sparing achieved through focal irradiation, and the improved normal tissue tolerance of high dose radiation through fractionation. Common adverse effects of SRT are rare but can occasionally be serious, notably radionecrosis that may induce neurological deficits in patients. Although SRS is often less well-tolerated, it remains the mainstay of treatment. To investigators knowledge, SRS and HSRT have not been prospectively compared.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a precise form of targeted radiation called stereotactic radiotherapy (SRT) for patients with a small number of brain metastases from cancers that are traditionally hard to treat with standard radiation (such as kidney cancer, sarcoma, or melanoma). **You may be eligible if...** - You are 18 years or older in good general health (WHO performance status 0–1) - You have 1 to 5 brain metastases from a solid tumor, confirmed by biopsy - Your cancer type is radiation-resistant (kidney cancer, sarcoma, or melanoma), OR you had surgery to remove brain metastases and have 1–4 remaining lesions - Your brain lesions are between 10 and 25 mm in size **You may NOT be eligible if...** - You have more than 5 brain metastases - Your lesions are outside the 10–25 mm size range required for this study - You have previously received radiation to the brain - Your general health is too poor to tolerate treatment 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

RADIATIONHypofractionated SRT (stereotactic radiotherapy)

3\*10Gy over 1 week

RADIATIONHistorical single-dose SRS (stereotactic radiosurgery)

20 to 25Gy/1 fraction


Locations(15)

CHU

Bordeaux, France

Institut Bergonié

Bordeaux, France

CHU

Brest, France

Centre François Baclesse

Caen, France

CHU

Grenoble, France

Centre Guillaume le Conquérant

Le Havre, France

Groupe hospitalier Bretagne Sud

Lorient, France

Centre Antoine Lacassagne

Nice, France

La Pitié Salpétrière

Paris, France

Centre hospitalier Lyon Sud

Pierre-Bénite, France

Centre Eugène Marquis

Rennes, France

Centre Henri Becquerel

Rouen, France

Centre d'Oncologie et Radiothérapie Saint-Jean

Saint-Doulchard, France

Institut Claudius Regaud

Toulouse, France

Gustave Roussy

Villejuif, France

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NCT05102747


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