Hypofractionated (3×10 Gy) versus single‑dose (20–25 Gy) stereotactic radiotherapy for limited brain metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase III trial compares hypofractionated stereotactic radiotherapy (3×10 Gy) to the historical single‑dose stereotactic radiosurgery (20–25 Gy) for patients with up to five brain metastases. Eligible lesions are generally 10–25 mm with a maximum cumulative gross tumor volume of 30 cm3, and patients must have good performance status and no bleeding lesions or meningeal carcinomatosis. The protocol includes standard target definition and delivery of stereotactic radiotherapy and will record tumor control, neurological function, toxicity, and health‑economic outcomes. Results aim to inform decisions about dose fractionation by balancing tumor control, side effects, patient convenience, and cost.

Why it matters

Who can join: the full rules

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
* 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

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

Where it's running

• Chu
  Brest, France Recruiting
• Centre François Baclesse
  Caen, France Recruiting
• Centre Guillaume le Conquérant
  Le Havre, France Recruiting
• Groupe hospitalier Bretagne Sud
  Lorient, France Recruiting
• Centre Eugène Marquis
  Rennes, France Recruiting
• Centre d'Oncologie et Radiothérapie Saint-Jean
  Saint-Doulchard, France Recruiting

Study contacts

• Study coordinator: Dinu STEFAN, MD
• Email: d.stefan@baclesse.unicancer.fr
• Phone: +33 (0)2 32 45 50 20

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.