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. (OligoBM-01)

January 26, 2026 updated by: Centre Francois Baclesse

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

504

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France
        • Not yet recruiting
        • Institut Bergonié
        • Contact:
          • Nicolas MILHADE, MD
        • Principal Investigator:
          • Nicolas MILHADE, MD
      • Bordeaux, France
        • Not yet recruiting
        • CHU
        • Contact:
          • Aymeri HUCHET, MD
        • Principal Investigator:
          • Aymeri HUCHET, MD
      • Brest, France
        • Recruiting
        • CHU
        • Principal Investigator:
          • Francois LUCIA, MD
        • Contact:
      • Caen, France, 14076
        • Recruiting
        • Centre François Baclesse
        • Contact:
          • Jean-Michel GRELLARD
        • Principal Investigator:
          • Dinu STEFAN, MD
        • Contact:
          • Dinu STEFAN, MD
      • Grenoble, France
        • Not yet recruiting
        • CHU
        • Contact:
          • Andrea DESAGNEAUX, MD
        • Principal Investigator:
          • Andrea DESAGNEAUX, MD
      • Le Havre, France
        • Recruiting
        • Centre Guillaume Le Conquerant
        • Principal Investigator:
          • Paul LESUEUR, MD
        • Contact:
      • Lorient, France
        • Recruiting
        • Groupe Hospitalier Bretagne Sud
        • Principal Investigator:
          • Christian SIRE, MD
        • Contact:
      • Nice, France
        • Not yet recruiting
        • Centre Antoine Lacassagne
        • Contact:
          • Pierre Yves BONDIAU, MD
        • Principal Investigator:
          • Pierre Yves BONDIAU, MD
      • Paris, France
        • Not yet recruiting
        • La Pitié Salpêtrière
        • Contact:
          • Julian JACOB, MD
        • Principal Investigator:
          • Julian JACOB, MD
      • Pierre-Bénite, France
        • Not yet recruiting
        • Centre Hospitalier Lyon Sud
        • Principal Investigator:
          • Loic FEUVRET, MD
        • Contact:
          • Loic FEUVRET, MD
      • Rennes, France
        • Recruiting
        • Centre Eugène Marquis
        • Contact:
        • Principal Investigator:
          • Khémara GNEP, MD
      • Rouen, France
        • Not yet recruiting
        • Centre Henri Becquerel
        • Contact:
          • Ovidiu VERESEZAN, MD
        • Principal Investigator:
          • Ovidiu VERESEZAN, MD
      • Saint-Doulchard, France
        • Recruiting
        • Centre d'oncologie et radiothérapie Saint-Jean
        • Contact:
        • Principal Investigator:
          • Thomas Frederic-Moreau, MD
      • Toulouse, France
        • Not yet recruiting
        • Institut Claudius Regaud
        • Contact:
          • Justine ATTAL, MD
        • Principal Investigator:
          • Justine ATTAL, MD
      • Villejuif, France
        • Not yet recruiting
        • Gustave Roussy
        • Contact:
          • Frédéric DHERMAIN, MD
        • Principal Investigator:
          • Frédéric DHERMAIN, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypofractionated SRT (stereotactic radiotherapy)
Radiation: Hypofractionated SRT (stereotactic radiotherapy)
3*10Gy over 1 week
Active Comparator: Historical single-dose SRS (stereotactic radiosurgery)
Radiation: Historical single-dose SRS (stereotactic radiosurgery)
20 to 25Gy/1 fraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy: Local control assessed by RANO-BM criteria
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Brain acute and late toxicities assessed by NCI CTCAE v5.0
Time Frame: 12 months
12 months
Radionecrosis by RANO-BM criteria
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Collaborators

Association de Neuro-Oncologues d'Expression Francaise

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2023

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2031

Study Registration Dates

First Submitted

October 6, 2021

First Submitted That Met QC Criteria

October 20, 2021

First Posted (Actual)

November 1, 2021

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A01622-39

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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