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RECRUITING
NCT05102747
NA

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

View on ClinicalTrials.gov

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

Interventions

RADIATION

Hypofractionated SRT (stereotactic radiotherapy)

3\*10Gy over 1 week

RADIATION

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