Actively Recruiting
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.
Led by Centre Francois Baclesse · Updated on 2026-01-27
504
Participants Needed
15
Research Sites
415 weeks
Total Duration
On this page
Sponsors
C
Centre Francois Baclesse
Lead Sponsor
A
Association de Neuro-Oncologues d'Expression Francaise
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- WHO performance status 0 or 1
- Eligible for stereotactic radiotherapy after multidisciplinary committee decision
- Diagnosed with up to 5 brain metastases from solid tumors, histologically confirmed
- Patients with one to four brain metastases after metastasectomy are eligible
- At least one and no more than five target lesions measuring 10 to 25 mm
- Maximum cumulative gross tumor volume (GTV) of 30 cm3
- Normal complete blood count
- No bleeding brain metastases or meningeal carcinomatosis
- Symptomatic brain metastases allowed
- Specific DS-GPA scores based on cancer type (renal, breast, melanoma, gastrointestinal, lung)
- No ongoing systemic treatment or appropriate washout period before and after radiotherapy
- Able to cooperate with treatment using a thermoformed mask
- Neuropsychological abilities suitable for protocol requirements
- Female participants with childbearing potential must use contraception
- Signed informed consent form
- Affiliated with social security system
You will not qualify if you...
- History of small cell lung cancer, germ-cell tumors, lymphoma, leukemia, or multiple myeloma within the last 5 years
- Brain metastases located in the brain stem or within 1 cm of the optic apparatus
- Associated neurodegenerative disease
- Symptoms requiring long-term corticosteroid use unrelated to brain metastases or cancer
- Contraindications to brain MRI or contrast agents
- Known hypersensitivity to contrast products
- Previous brain stereotactic irradiation or whole brain irradiation
- Hemorrhagic brain metastases
- Ongoing anti-angiogenic treatment without appropriate interruption
- Brain lesions too close together causing excessive radiation dose overlap
- Patients deprived of liberty or under guardianship
- Known pregnancy or breastfeeding
- Social or psychological conditions impairing study participation
- Participation in another therapeutic trial within the last 30 days
- Patients deprived of freedom or under guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
CHU
Bordeaux, France
Not Yet Recruiting
2
Institut Bergonié
Bordeaux, France
Not Yet Recruiting
3
CHU
Brest, France
Actively Recruiting
4
Centre François Baclesse
Caen, France, 14076
Actively Recruiting
5
CHU
Grenoble, France
Not Yet Recruiting
6
Centre Guillaume le Conquérant
Le Havre, France
Actively Recruiting
7
Groupe hospitalier Bretagne Sud
Lorient, France
Actively Recruiting
8
Centre Antoine Lacassagne
Nice, France
Not Yet Recruiting
9
La Pitié Salpétrière
Paris, France
Not Yet Recruiting
10
Centre hospitalier Lyon Sud
Pierre-Bénite, France
Not Yet Recruiting
11
Centre Eugène Marquis
Rennes, France
Actively Recruiting
12
Centre Henri Becquerel
Rouen, France
Not Yet Recruiting
13
Centre d'Oncologie et Radiothérapie Saint-Jean
Saint-Doulchard, France
Actively Recruiting
14
Institut Claudius Regaud
Toulouse, France
Not Yet Recruiting
15
Gustave Roussy
Villejuif, France
Not Yet Recruiting
Research Team
D
Dinu STEFAN, MD
CONTACT
J
Jean-Michel GRELLARD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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