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)

This is an interventional treatment trial for Brain Metastasis focused on measuring Stereotactic radiosurgery, Fractionated stereotactic radiotherapy Read More

Inclusion Criteria:

• Patients aged 18 years or older
• 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)
• Each targeted brain lesion(s) for SRT measuring at least 10 mm and no more than 25 mm in diameter; patients whose synchronous 1-5 BM include 4 lesions measuring less than 10 mm and/or more than 25 mm will be eligible (these lesions will be treated at the discretion of the investigator).
• Max cumulative GTV of 30cm3
• Patient with an extra-cranial complete response disease under systemic therapy (chemotherapy or targeted therapy);
• Patient with an extra-cranial partial response or stable disease for more than three months under systemic therapy (chemotherapy or targeted therapy);
• Absence of bleeding BM or meningeal carcinomatosis;
• Symptomatic BM are allowed

• DS-GPA score 0:

  • Renal cancer: DS-GPA 2,5 or more
  • Breast cancer: DS-GPA 2,5 or more
  • Melanoma: DSGPA 3 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)
• 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 form
• Patients affiliated to the social security system

Exclusion Criteria:

• Patients with small cell lung cancer, germ-cell tumours, lymphoma, leukemia and multiple myeloma;
• 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;
• Progressive extra-cranial disease;
• 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.
• Current or past history of second neoplasm diagnosed within the last 5 years
• Patient deprived of freedom or under guardianship