Traditional Incision and Drainage of Cutaneous Abscess Vs. Minimally Invasive Incision and Drainage With Vessel Loop: A Randomized Controlled Trail
Sponsor study identifier
Secondary identifiers
NIH
OTHER · WFCCC
interventional
16
1 country
3
Study Start
May 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This study is a prospective evaluation of systemic, intravenous high-dose methotrexate (HD-MTX, 8 g/m2) in patients with triple negative, HER2-positive, and hormone refractory breast cancer with leptomeningeal metastasis (LMD) with or without brain parenchymal involvement.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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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.
April 10, 2015
Actual (reported)April 21, 2015
Actual (reported)May 2015
Date type not reportedThis date has not been verified as actual or estimated.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Overall Survival (at 12 weeks)
The primary endpoint is survival at 12 weeks from first date of treatment. For the primary analysis, this will be dichotomized according to whether the patient achieves an OS greater than 12 weeks (i.e. survival rate). This cutoff has been selected based on reported OS data in historical controls.
12 weeks
One year survival
1 year
Progression Free Survival
From date of first treatment to the time of systemic or neurologic progression of disease whichever occurs first, assessed up to 2 years
Tolerability of Treatment - Number of Grade 3 or Higher Adverse Events
Up to 2 years
Number of Treatment Delays
Up to 2 years
Number of Dose Reductions
Up to 2 years
Treatment Cost
Up to 2 years
Percentage of Cytologic Sterilization
Up to 2 years
Enrolled patients will undergo treatment with HD-MTX (8 g/m2) as per current standard practice on an every 2 week schedule until disease progression or death from any cause. Treatment will be performed according to standard clinical practice. Surveillance imaging with or without cytologic evaluation will be performed as per standard clinical practice after every 2 cycles (\~28 days). Treatment will continue until there is unequivocal evidence of clinical or radiographic CNS or systemic disease progression, death from any cause, or intolerance.
Enrolled patients will undergo treatment with HD-MTX (8 g/m2) as per current standard practice on an every 2 week schedule until disease progression or death from any cause. Treatment will be performed according to standard clinical practice. Surveillance imaging with or without cytologic evaluation will be performed as per standard clinical practice after every 2 cycles (\~28 days). Treatment will continue until there is unequivocal evidence of clinical or radiographic CNS or systemic disease progression, death from any cause, or intolerance.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287, United States
Siteman Cancer Center- Washington University School of Medicine in St. Louis
St Louis, Missouri, 63130, United States
Comprehensive Cancer Center at Wake Forest University (CCCWFU)
Winston-Salem, North Carolina, 27157, United States
Roy Strowd, MD
Wake Forest University Health Sciences
First Submitted
April 10, 2015
First Posted
April 21, 2015
Study Start
May 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2026
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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