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Study identifier: NCT05102747 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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.

Condition: Brain Metastasis · Oligoprogression  ·  Sponsor: Centre Francois Baclesse

PhaseNA
Planned participants504
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Dinu STEFAN, MD  ·  +33 (0)2 32 45 50 20  ·  d.stefan@baclesse.unicancer.fr

Jean-Michel GRELLARD  ·  +33 (0)2 31 45 50 02  ·  jm.grellard@baclesse.unicancer.fr

Always discuss trial participation with your own doctor first.

Locations (15)

CHUBordeaux, FranceNot Yet Recruiting
Institut BergoniéBordeaux, FranceNot Yet Recruiting
CHUBrest, FranceRecruiting
Centre François BaclesseCaen, FranceRecruiting
CHUGrenoble, FranceNot Yet Recruiting
Centre Guillaume le ConquérantLe Havre, FranceRecruiting
Groupe hospitalier Bretagne SudLorient, FranceRecruiting
Centre Antoine LacassagneNice, FranceNot Yet Recruiting
La Pitié SalpétrièreParis, FranceNot Yet Recruiting
Centre hospitalier Lyon SudPierre-Bénite, FranceNot Yet Recruiting
Centre Eugène MarquisRennes, FranceRecruiting
Centre Henri BecquerelRouen, FranceNot Yet Recruiting

+ 3 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05102747