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Brain MetastasisOligoBM-01NCT05102747

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.

A study testing Hypofractionated SRT (stereotactic radiotherapy) and Historical single-dose SRS (stereotactic radiosurgery) in people with Brain Metastasis and Oligoprogression, run by Centre Francois Baclesse at 15 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Metastasis, Oligoprogression
What is being tested?
Hypofractionated SRT (stereotactic radiotherapy) and Historical single-dose SRS (stereotactic radiosurgery)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
504 participants
Where
15 sitesFrance
Study dates
12 Jan 2023to Jan 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged ≥ 18 years
  • WHO performance status 0 or 1;
  • Patient eligible for SRT after a multidisciplinary committee decision; Patient with BMs from radioresistant cancer (renal cell carcinoma, sarcoma, melanoma) is eligible
  • Patient having up to 5 BM of solid tumours with an histologically proven diagnoses; patients who have had a metastasectomy and having 1 to 4 BM lesions is eligible (ANOCEF recommendations); post-operative cavity must be treated by radiosurgery according to local procedures with respect of non-inclusion criteria* (cavity will not be analyzed for efficacy)
  • Presence of at least one and no more than 5 target lesions for SRT, measuring between 10 and 25 mm. In the event of synchronous BM, lesions measuring less than 10mm or more than 25mm (1 to 4 lesions) will be treated at the discretion of the investigator
  • Max cumulative GTV of 30cm3
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  • Normal complete blood count (CBC)
  • Absence of bleeding BM or meningeal carcinomatosis;
  • Symptomatic BM are allowed
  • DS-GPA score:
  • Renal cancer: DS-GPA 2,5 or more
  • Breast cancer: DS-GPA 2,5 or more
  • Melanoma: DS-GPA 1.5 or more
  • Gastro-instestinal (GI) cancer: DSGPA 3 or more
  • Adenocarcinoma lung cancer: DS-GPA 2 or more (DS-GPAmol)
  • Squamous lung cancer : DS-GPA 2,5 or more (DS-GPAmol)
  • For cancers where the DS-GPA score is not applicable, the patient is eligible if eligibility criteria are met
  • Patient with no concomitant systemic treatment; in case of ongoing systemic treatment, wash out period of 3-7 days before and after SRT, depending of drug and at the discretion of investigator;
  • Patient sufficiently cooperating to perform the treatment with the use of a thermoformed mask;
  • Patient whose neuropsychological abilities allow to follow the requirements of the protocol;
  • Female with childbearing potential must use adequate contraception
  • Signed informed consent formOligoBM-01 Trial - ID-RCB number: 2021-A01622-39 - version 3.1 dated from 2023-06-22 Page 9 of 51
  • Patients affiliated to the social security system

Who cannot join

  • Patients with current or past history small cell lung cancer, germ-cell tumours, lymphoma, leukemia and multiple myeloma within the last 5 years;
  • Patients with metastases in the brain stem, or within 1 cm of the optic apparatus;
  • Patients with an associated neurodegenerative disease;
  • Any symptoms not attributable to BM or cancer disease requiring long term corticosteroid use (regardless of dose);
  • Contraindication to perform the brain MRI or gadolinium or iodinated contrast;
  • Known hypersensitivity to the contrast product or to any their excipients
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  • Patients with previous brain stereotactic irradiation
  • Whole brain irradiation history;
  • Haemorrhagic metastasis;
  • Ongoing anti angiogenic treatment (treatment should be held 3-7 days before irradiation and re-initiated 3-7 days after irradiation for patient to be eligible);
  • Patients with too close brain lesions for whom a treatment plan on one target metastasis delivers a dose > 5 Gy on other concomitant metastasis ;
  • Patient deprived of liberty or under guardianship;
  • Known pregnancy or breastfeeding
  • Any geographical conditions, social and associated psychopathology that may compromise the patient's ability to participate in the study;
  • Participation in a therapeutic trial for less than 30 days.
  • Patient deprived of freedom or under guardianship

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dinu STEFAN, MD contact

+33 (0)2 32 45 50 20

d.stefan@baclesse.unicancer.fr

Jean-Michel GRELLARD contact

+33 (0)2 31 45 50 02

jm.grellard@baclesse.unicancer.fr

15 sites in 1 country

France15 sites, 15 recruiting

  • CHU

    Bordeaux

    Aymeri HUCHET, MD

    Aymeri HUCHET, MD

    Not yet recruiting

  • Institut Bergonié

    Bordeaux

    Nicolas MILHADE, MD

    Nicolas MILHADE, MD

    Not yet recruiting

  • CHU

    Brest

    Francois LUCIA, MD, 33230338260, francois.lucia@chu-brest.fr

    Francois LUCIA, MD

    Recruiting

  • Centre François Baclesse

    Caen, 14076

    Dinu STEFAN, MD

    Jean-Michel GRELLARD

    Recruiting

  • CHU

    Grenoble

    Andrea DESAGNEAUX, MD

    Andrea DESAGNEAUX, MD

    Not yet recruiting

  • Centre Guillaume le Conquérant

    Le Havre

    Paul LESUEUR, MD, 33235136613, p.lesueur@cglc.fr

    Paul LESUEUR, MD

    Recruiting

  • Groupe hospitalier Bretagne Sud

    Lorient

    Christian SIRE, MD, 33297068027, c.sire@ghbs.bzh

    Christian SIRE, MD

    Recruiting

  • Centre Antoine Lacassagne

    Nice

    Pierre Yves BONDIAU, MD

    Pierre Yves BONDIAU, MD

    Not yet recruiting

  • La Pitié Salpétrière

    Paris

    Julian JACOB, MD

    Julian JACOB, MD

    Not yet recruiting

  • Centre hospitalier Lyon Sud

    Pierre-Bénite

    Loic FEUVRET, MD

    Loic FEUVRET, MD

    Not yet recruiting

  • Centre Eugène Marquis

    Rennes

    Khémara GNEP, MD, 33299253020, i.lecouillard@rennes.unicancer.fr

    Khémara GNEP, MD

    Recruiting

  • Centre Henri Becquerel

    Rouen

    Ovidiu VERESEZAN, MD

    Ovidiu VERESEZAN, MD

    Not yet recruiting

  • Centre d'Oncologie et Radiothérapie Saint-Jean

    Saint-Doulchard

    Thomas Frederic-Moreau, MD, 33662288308, thomas.fredericmoreau@centre-saint-jean.fr

    Thomas Frederic-Moreau, MD

    Recruiting

  • Institut Claudius Regaud

    Toulouse

    Justine ATTAL, MD

    Justine ATTAL, MD

    Not yet recruiting

  • Gustave Roussy

    Villejuif

    Frédéric DHERMAIN, MD

    Frédéric DHERMAIN, MD

    Not yet recruiting

Other trials in France

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.

Read more

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.

Being tested
Hypofractionated SRT (stereotactic radiotherapy), Historical single-dose SRS (stereotactic radiosurgery)
Keywords
Stereotactic radiosurgery, Fractionated stereotactic radiotherapy
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hypofractionated SRT (stereotactic radiotherapy)Radiation

    3*10Gy over 1 week

  • Historical single-dose SRS (stereotactic radiosurgery)Radiation

    20 to 25Gy/1 fraction

Study groups in NCT05102747
Study groupRoleWhat they receive
Hypofractionated SRT (stereotactic radiotherapy)ExperimentalNot described
Receives: Radiation: Hypofractionated SRT (stereotactic radiotherapy)
Historical single-dose SRS (stereotactic radiosurgery)Active comparatorNot described
Receives: Radiation: Historical single-dose SRS (stereotactic radiosurgery)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy: Local control assessed by RANO-BM criteria

    Measured: 12 months

Secondary outcomes (2)

  1. Brain acute and late toxicities assessed by NCI CTCAE v5.0

    Measured: 12 months

  2. Radionecrosis by RANO-BM criteria

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2021
  2. Study start12 Jan 2023
  3. Primary completionJan 2030 (estimated)
  4. Study completionJan 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
504 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05102747
Sponsor's protocol ID
2021-A01622-39
Acronym
OligoBM-01
Status last verified
Jan 2026
First submitted
6 Oct 2021
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Hypofractionated SRT (stereotactic radiotherapy) and Historical single-dose SRS (stereotactic radiosurgery) in people with Brain Metastasis and Oligoprogression, run by Centre Francois Baclesse at 15 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dinu STEFAN, MD (+33 (0)2 32 45 50 20, d.stefan@baclesse.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy: Local control assessed by RANO-BM criteria (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05102747.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.

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