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Compares treatment options for Brain Metastasis
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.
ClinicalTrials.gov ID: NCT05102747
What this study is testing
- What it's testing
- Brain metastases (BM) are a common systemic cancer manifestation which incidence increases. Therapeutic options include whole-brain radiotherapy (WBRT), surgery, and stereotactic radiosurgery (SRS).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- 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...
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Brest, France
- Caen, France
- Grenoble, France
- Le Havre, France
- Lorient, France
- Nice, France
- Paris, France
- Pierre-Bénite, France
- Rennes, France
- Rouen, France
- Saint-Doulchard, France
- Toulouse, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Brest, France; Caen, France; Grenoble, France; Le Havre, France; Lorient, France and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.