Status:
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.
Lead Sponsor:
Centre Francois Baclesse
Collaborating Sponsors:
Association de Neuro-Oncologues d'Expression Francaise
Conditions:
Brain Metastasis
Oligoprogression
Eligibility:
All Genders
18+ years
Phase:
NA
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). T...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2031
Estimated Enrollment :
504 Patients enrolled
Trial Details
Trial ID
NCT05102747
Start Date
January 12 2023
End Date
January 1 2031
Last Update
January 27 2026
Active Locations (15)
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1
CHU
Bordeaux, France
2
Institut Bergonié
Bordeaux, France
3
CHU
Brest, France
4
Centre François Baclesse
Caen, France, 14076