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Brief Title: 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.
Official Title: 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.
Study ID: NCT05102747
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Centre Oscar Lambret, Lille, , 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