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Comparing two types of focused radiation for cancer that has spread to the brain

Compares 3 radiation sessions with 1 single session in brain metastases.

Key facts

Who runs it
Centre Francois Baclesse
Where
France15 sites in 1 countryChoose a country to see its sites
Trial code
Registry title
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.
Status
Recruiting
People taking part
504 people, planned
Started
12 Jan 2023
Expected to end
Jan 2031
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Hypofractionated SRT (stereotactic radiotherapy)
  • Historical single-dose SRS (stereotactic radiosurgery)
Record updated
27 January 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 32 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Patients with previous brain stereotactic irradiation
  • Whole brain irradiation history
  • 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
  • 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 an associated neurodegenerative disease
  • Any symptoms not attributable to BM or cancer disease requiring long term corticosteroid use (regardless of dose)
  • Known hypersensitivity to the contrast product or to any their excipients
  • Any geographical conditions, social and associated psychopathology that may compromise the patient's ability to participate in the study
  • Patients with metastases in the brain stem, or within 1 cm of the optic apparatus
  • Contraindication to perform the brain MRI or gadolinium or iodinated contrast
  • Haemorrhagic metastasis
  • Patient deprived of liberty or under guardianship
  • Known pregnancy or breastfeeding
  • Participation in a therapeutic trial for less than 30 days
  • Patient deprived of freedom or under guardianship

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Hypofractionated SRT (stereotactic radiotherapy)Treatment being tested
  • Historical single-dose SRS (stereotactic radiosurgery)Existing treatment, for comparison

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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.
Plain-language title
Comparing two types of focused radiation for cancer that has spread to the brainGenerated from the registry record. The registry title is the official one.
Record updated
27 January 2026