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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
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
504
Start Date
2023-01-12
Completion Date
2031-01
Last Updated
2026-01-27
Healthy Volunteers
No
Conditions
Interventions
Hypofractionated SRT (stereotactic radiotherapy)
3\*10Gy over 1 week
Historical 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