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.

NCT ID: NCT05102747

Last Updated: 2026-01-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 504 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-12
• Study Completion Date: 2031-01-31

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.

Conditions

Brain Metastasis; Oligoprogression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hypofractionated SRT (stereotactic radiotherapy)

Group Type: EXPERIMENTAL

Hypofractionated SRT (stereotactic radiotherapy)

Intervention Type: RADIATION

3\*10Gy over 1 week

Historical single-dose SRS (stereotactic radiosurgery)

Group Type: ACTIVE_COMPARATOR

Historical single-dose SRS (stereotactic radiosurgery)

Intervention Type: RADIATION

20 to 25Gy/1 fraction

Interventions

Hypofractionated SRT (stereotactic radiotherapy)

3\*10Gy over 1 week

Intervention Type: RADIATION

Historical single-dose SRS (stereotactic radiosurgery)

20 to 25Gy/1 fraction

Intervention Type: RADIATION

Eligibility Criteria

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Association de Neuro-Oncologues d'Expression Francaise

OTHER

Sponsor Role: collaborator

Centre Francois Baclesse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU

Bordeaux, , France

Site Status: NOT_YET_RECRUITING

Institut Bergonié

Bordeaux, , France

Site Status: NOT_YET_RECRUITING

CHU

Brest, , France

Site Status: RECRUITING

Centre François Baclesse

Caen, , France

Site Status: RECRUITING

CHU

Grenoble, , France

Site Status: NOT_YET_RECRUITING

Centre Guillaume le Conquérant

Le Havre, , France

Site Status: RECRUITING

Groupe hospitalier Bretagne Sud

Lorient, , France

Site Status: RECRUITING

Centre Antoine Lacassagne

Nice, , France

Site Status: NOT_YET_RECRUITING

La Pitié Salpétrière

Paris, , France

Site Status: NOT_YET_RECRUITING

Centre hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status: NOT_YET_RECRUITING

Centre Eugène Marquis

Rennes, , France

Site Status: RECRUITING

Centre Henri Becquerel

Rouen, , France

Site Status: NOT_YET_RECRUITING

Centre d'Oncologie et Radiothérapie Saint-Jean

Saint-Doulchard, , France

Site Status: RECRUITING

Institut Claudius Regaud

Toulouse, , France

Site Status: NOT_YET_RECRUITING

Gustave Roussy

Villejuif, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Dinu STEFAN, MD

Role: CONTACT

d.stefan@baclesse.unicancer.fr

+33 (0)2 32 45 50 20

Jean-Michel GRELLARD

Role: CONTACT

jm.grellard@baclesse.unicancer.fr

+33 (0)2 31 45 50 02

Facility Contacts

Aymeri HUCHET, MD

Role: primary

Nicolas MILHADE, MD

Role: primary

Francois LUCIA, MD

Role: primary

francois.lucia@chu-brest.fr

33230338260

Dinu STEFAN, MD

Role: primary

Jean-Michel GRELLARD

Role: backup

Andrea DESAGNEAUX, MD

Role: primary

Paul LESUEUR, MD

Role: primary

p.lesueur@cglc.fr

33235136613

Christian SIRE, MD

Role: primary

c.sire@ghbs.bzh

33297068027

Pierre Yves BONDIAU, MD

Role: primary

Julian JACOB, MD

Role: primary

Loic FEUVRET, MD

Role: primary

Khémara GNEP, MD

Role: primary

i.lecouillard@rennes.unicancer.fr

33299253020

Ovidiu VERESEZAN, MD

Role: primary

Thomas Frederic-Moreau, MD

Role: primary

thomas.fredericmoreau@centre-saint-jean.fr

33662288308

Justine ATTAL, MD

Role: primary

Frédéric DHERMAIN, MD

Role: primary

Other Identifiers

2021-A01622-39

Identifier Type: -

Identifier Source: org_study_id