Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05102747

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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