Ignite Creation Date:
2024-05-06 @ 12:43 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01645839
Status:
COMPLETED
Last Update Posted:
2019-06-12
First Post:
2012-07-16
Brief Title:
Interest of Intrathecal Chemotherapy With Liposomal Cytarabine DepoCyte in Meningeal Metastasis of Breast Cancer
Sponsor:
Centre Oscar Lambret
Organization:
Centre Oscar Lambret
Study Overview
Official Title:
Role of Intrathecal Chemotherapy With Liposomal Cytarabine DepoCyte in Patients Wih Leptomeningeal Metastasis of Breast Cancer A Randomized Phase III Study
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEPOSEIN
Brief Summary:
The purpose of this study is to evaluate the impact of Depocyte IT combined with the systemic standard treatment in terms of clinical andor radiological neuromeningeal progression free survival SSPN
Detailed Description:
After the signature of the consent form and validation of the eligibility inclusion criteria patients will be randomized Treatment will start within a maximum of 10 days after randomization
Arm A Systemic standard treatment without DepoCyte Arm B Systemic standard treatment with DepoCyte DepoCyte will be slowly administered by injection 1 to 5 minutes of 50 mg 5 mL into the CSF via a lumbar puncture or a ventricular device
every 14 - 2 days for a total of 5 cycles induction treatment
then every 28 -4 days until progression maintenance treatment Standard systemic treatment by chemotherapy targeted therapy or hormonal therapy is at the discretion of the investigator taking into account the breast cancer sub-type and previous treatments The systemic treatment will be determined before randomization It can be modified at any time according to the treating oncologist Focal radiotherapy to symptomatic sites is allowed The usual follow-up of patients treated by IT DepoCyte of every 14 days for the first two months and then monthly is not modified in patients of Arm B Evaluation in Arm A will be matched to Arm B and are thus more frequent than routinely done because such patients are usually seen every 3 weeks The follow-up for systemic disease is left at the discretion of the treating oncologist
Translational research Only Oscar Lambret Center will participate in this exploratory analysis For patients who accept to participate a 10 mL CSF sample will be collected at enrollment and once per month just before treatment
Arm A at monthly visit
Arm B at a IT injection once per month just before DepoCyte injection Samples will be sent to the analysis center as soon as possible and will be destroyed at the end of all study-related procedures
Arm A Systemic standard treatment without DepoCyte Arm B Systemic standard treatment with DepoCyte DepoCyte will be slowly administered by injection 1 to 5 minutes of 50 mg 5 mL into the CSF via a lumbar puncture or a ventricular device
every 14 - 2 days for a total of 5 cycles induction treatment
then every 28 -4 days until progression maintenance treatment Standard systemic treatment by chemotherapy targeted therapy or hormonal therapy is at the discretion of the investigator taking into account the breast cancer sub-type and previous treatments The systemic treatment will be determined before randomization It can be modified at any time according to the treating oncologist Focal radiotherapy to symptomatic sites is allowed The usual follow-up of patients treated by IT DepoCyte of every 14 days for the first two months and then monthly is not modified in patients of Arm B Evaluation in Arm A will be matched to Arm B and are thus more frequent than routinely done because such patients are usually seen every 3 weeks The follow-up for systemic disease is left at the discretion of the treating oncologist
Translational research Only Oscar Lambret Center will participate in this exploratory analysis For patients who accept to participate a 10 mL CSF sample will be collected at enrollment and once per month just before treatment
Arm A at monthly visit
Arm B at a IT injection once per month just before DepoCyte injection Samples will be sent to the analysis center as soon as possible and will be destroyed at the end of all study-related procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2010-023134-23 | EUDRACT_NUMBER | None | None |