DEPOSEIN
Role of Intrathecal Chemotherapy With Liposomal Cytarabine (DepoCyte®) in Patients Wih Leptomeningeal Metastasis of Breast Cancer. A Randomized Phase III Study.
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
74
1 country
10
Study Start
August 30, 2011
Actual (reported)Primary Completion
August 2018
Actual (reported)Study Completion
March 1, 2019
Actual (reported)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)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 30, 2011
Actual (reported)July 16, 2012
Actual (reported)July 20, 2012
Actual (reported)August 2018
Actual (reported)March 1, 2019
Actual (reported)Leptomeningeal disease-related neurological progression-free survival (LM-PFS)
time between randomization and date of first leptomeningeal progression (defined according to clinical-neurological or imaging criteria) or date of death (death from any cause) whatever occurs first. Patients alive without neurological progression at the time of the last follow-up will be censored at the date of the last visit.
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)
Response of leptomeningeal metastases
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)
Progression free survival (PFS)
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)
Overall survival
Until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
Tolerance to DepoCyte® according to NCI CTCAE V4.0
Up to 30 days after the last administration of the study treatment
Q-TWiST
Calculated at the end of study
Quality of life (questionnaire QLQ C30, BN20 and C15)
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)
Autonomy in daily life (questionnaire Instrumental Activities in Daily Living)
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)
Emotional state of the patient assessed by the psychological distress score
At baseline
Intrathecal injection of Liposomal Cytarabine (Depocyte®) every 14 ± 2 days for a total of 5 cycles and then every 28 ± 4 days until progression.
No intrathecal injection.
50mg (5 mL) by slow intrathecal injection (1-5 minutes) directly into the cerebrospinal fluid (CSF) via a ventricular catheter directly into the lumbar sac during a lumbar puncture.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Liposomal Cytarabine
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
View registry recordCentre Hospitalier Universitaire Groupe Sud
Amiens, 80054, France
Centre Hospitalier Universitaire Lyon
Bron, 69677, France
Centre G.F. Leclerc
Dijon, 21079, France
CHU de Grenoble
Grenoble, 38042, France
Centre Oscar Lambret
Lille, 59020, France
Centre Hospitalier Bretagne Sud
Lorient, 56100, France
Centre Val d'Aurelle
Montpellier, 34298, France
Le Rhun E, Wallet J, Mailliez A, Le Deley MC, Rodrigues I, Boulanger T, Lorgis V, Barriere J, Robin YM, Weller M, Bonneterre J. Intrathecal liposomal cytarabine plus systemic therapy versus systemic chemotherapy alone for newly diagnosed leptomeningeal metastasis from breast cancer. Neuro Oncol. 2020 Apr 15;22(4):524-538. doi: 10.1093/neuonc/noz201.
Emilie LERHUN, MD
Centre Oscar Lambret
74 participants (actual enrollment reported by the registry).
First Submitted
July 16, 2012
First Posted
July 20, 2012
Study Start
August 30, 2011
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
Centre Hospitalier Universitaire de Nice
Nice, 06002, France
Centre Antoine Lacassagne
Nice, 06189, France
Hôpital Salpétrière
Paris, 75013, France
August 2018
Actual (reported)Study Completion
March 1, 2019
Actual (reported)Last Updated
June 12, 2019
Record last verified: 2019-06
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Source: ClinicalTrials.gov.
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