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
1 other identifier
interventional
504
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2021
CompletedFirst Posted
Study publicly available on registry
November 1, 2021
CompletedStudy Start
First participant enrolled
January 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2031
January 27, 2026
January 1, 2026
7 years
October 6, 2021
January 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy: Local control assessed by RANO-BM criteria
12 months
Secondary Outcomes (2)
Brain acute and late toxicities assessed by NCI CTCAE v5.0
12 months
Radionecrosis by RANO-BM criteria
12 months
Study Arms (2)
Hypofractionated SRT (stereotactic radiotherapy)
EXPERIMENTALHistorical single-dose SRS (stereotactic radiosurgery)
ACTIVE COMPARATORInterventions
3\*10Gy over 1 week
20 to 25Gy/1 fraction
Eligibility Criteria
You may qualify if:
- 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
- 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)
- +7 more criteria
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
CHU
Bordeaux, France
Institut Bergonié
Bordeaux, France
CHU
Brest, France
Centre François Baclesse
Caen, 14076, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2021
First Posted
November 1, 2021
Study Start
January 12, 2023
Primary Completion (Estimated)
January 1, 2030
Study Completion (Estimated)
January 1, 2031
Last Updated
January 27, 2026
Record last verified: 2026-01