Interest of Intrathecal Chemotherapy With Liposomal Cytarabine (DepoCyte®) in Meningeal Metastasi… (NCT01645839) | Clinical Trial Compass
CompletedPhase 3
Interest of Intrathecal Chemotherapy With Liposomal Cytarabine (DepoCyte®) in Meningeal Metastasis of Breast Cancer
France74 participantsStarted 2011-08-30
Plain-language summary
The purpose of this study is to evaluate the impact of Depocyte® IT combined with the systemic standard treatment in terms of clinical and/or radiological neuromeningeal progression free survival (SSPN)
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Histologically proven invasive breast cancer
* New diagnosis of leptomeningeal metastasis confirmed by CSF cytology, or by the combination of typical clinical symptoms or signs with typical MRI abnormalities
* Cerebrospinal MRI criteria: no visible lesion, or meningeal metastases \<0.5 cm, or \>0.5 cm largest diameter if focal radiotherapy planned
* Indication for systemic treatment (chemotherapy and/or targeted therapy and/or hormonal therapy) at the time of enrollment. Systemic treatment is at the discretion of the investigator (in collaboration with the treating oncologist if different) according to cancer characteristics, previous treatments, and clinical and biological disease characteristics. Focal radiotherapy is permitted.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* Patients unable to walk due to a palsy but able to use a wheelchair are considered as ambulatory patients
* Expected survival of at least 2 months. Patients with rapidly progressive systemic disease are not eligible for this trial
* Co-existing asymptomatic brain metastases are permitted
* In case of suspicion of CSF flow block, or after focal radiotherapy for the treatment of a CSF flow block, a CSF flow study will be performed (isotopic method) to confirm the absence of CSF block
* Patients must have recovered from acute adverse events of other anticancer treatments previously administered
* Adequate bone marrow, renal, and hepatic function with the follow…
Timeframe: At baseline, then every 2 weeks for 2 months, after 2 months from baseline once a month until progression (up to 6 months) and at the end of the study (up to 6 months)