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NotablePrimary and study completion pushed from Jun 2026 to Jun 2027
Site details revised at 1 of 2 sites
v27
MinorStudy sites: 1 to 2
Eligibility criteria expanded, about 5 words
v26
MinorSite contact updatedv25
MinorRe-verified, no change to tracked fieldsv24
NotableEnrollment target: 24 to 50v23Show 6 more changesShow less
Primary and study completion dates: Aug 16, 2022 to Jun 2026
Trial status: Completed to Recruiting
Study description expanded, about 211 words
Site details revised
Eligibility criteria shortened, about 3 words
Collaborators expanded, about 4 words
Show 21 earlier versionsHide 21 earlier versions
NotableResults first posted: Oct 13, 2023v22
MinorSecondary endpoints: 10 to 9v21
NotablePhase: Not applicable to Phase 4
Secondary endpoints: 17 to 10
Primary endpoint revised
Publications expanded, about 66 words
v20
MinorTrial status: Active, Not Recruiting to Completed
Primary and study completion dates changed from estimate of Jul 2022 to Aug 16, 2022
v19
MinorPrimary and study completion dates: Apr 2022 to Jul 2022v18
MinorTrial status: Recruiting to Active, Not Recruiting
Enrollment target: estimated 20 to confirmed 24
Primary and study completion dates: Feb 2022 to Apr 2022
Site details revised
v17
NotablePrimary and study completion dates: Feb 2021 to Feb 2022v16
MinorPrimary completion date: Sep 15, 2020 to Feb 2021
Study completion date: Oct 15, 2020 to Feb 2021
v15
NotableTrial status: Suspended to Recruiting
Site details revised
v14
MinorSecondary endpoints: 14 to 17v13
StoppedTrial status: Recruiting to SuspendedSponsor's reason: COVID-19
Site details revised
v12
MinorSite contact updated
Collaborators shortened, about 4 words
v11
NotablePrimary completion date: Sep 15, 2019 to Sep 15, 2020
Study completion date: Oct 15, 2019 to Oct 15, 2020
Site contact updated
v10
NotableTrial status: Suspended to Recruiting
Site details revised
v9
StoppedTrial status: Recruiting to SuspendedSponsor's reason: Resources
Site details revised
v8
NotableTrial status: Suspended to Recruiting
Site details revised
v7
StoppedTrial status: Recruiting to SuspendedSponsor's reason: Resources
Site details revised
v6
MinorEligibility criteria expanded, about 31 words
Secondary endpoints: details revised at 1 of 14 entries
v5
MinorRe-verified, no change to tracked fieldsv4
NotablePrimary completion date: Mar 15, 2018 to Sep 15, 2019
Study completion date: Mar 15, 2019 to Oct 15, 2019
v3
MinorEligibility criteria expanded, about 1 wordv2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The hypothesis of this study is that paclitaxel levels increase chromosomal instability (CIN) in tumors and this is lethal to tumors that have pre-existing CIN. Treatment will be administered on an outpatient basis. Paclitaxel will be initiated as standard infusions on days 1, 8, and 15 of a 21-day cycle. Participants will continue with paclitaxel for cycles 2-4 prior to surgery.