NCT05102747: OligoBM-01

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.

Recruiting now NA Last updated 26 January 2026

What this trial tests

NA trial testing Hypofractionated SRT (stereotactic radiotherapy) in Brain Metastasis in 504 participants. Currently enrolling.

Timeline

12 January 2023

Primary endpoint
1 January 2030

1 January 2031

Quick facts

Lead sponsor	Centre Francois Baclesse
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	504
Start date	12 January 2023
Primary completion	1 January 2030
Estimated completion	1 January 2031
Sites	15 locations across France

Drugs / interventions tested

• Hypofractionated SRT (stereotactic radiotherapy)
• Historical single-dose SRS (stereotactic radiosurgery)

Conditions studied

• Brain Metastasis — all drugs for Brain Metastasis →
• Oligoprogression — all drugs for Oligoprogression →

Sponsor

Centre Francois Baclesse — full company profile →

Who can join

18 and older, any sex, with Brain Metastasis or Oligoprogression. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Efficacy: Local control assessed by RANO-BM criteria
  Time frame: 12 months

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.