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NCT03655080

Pulsed Abraxane and Radiotherapy for Improving and Maintaining Ambulation After Cancer-Related Cord Compression

Terminated Phase 2 Results posted Last updated 4 February 2025
What this trial tests

Phase 2 trial testing Radiation therapy in Cord Compression in 2 participants. Terminated before completion.

Timeline
9 January 2019
Primary endpoint
22 February 2021
15 June 2021

Quick facts

Lead sponsorWashington University School of Medicine
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment2
Start date9 January 2019
Primary completion22 February 2021
Estimated completion15 June 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Cord Compression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Ambulatory Status Primary · 1 month

-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.

Paraplegic
GroupValue95% CI
Nab-Paclitaxel and Radiation Therapy0
Not ambulatory
GroupValue95% CI
Nab-Paclitaxel and Radiation Therapy1
Ambulatory with aid
GroupValue95% CI
Nab-Paclitaxel and Radiation Therapy0
Ambulatory without aid
GroupValue95% CI
Nab-Paclitaxel and Radiation Therapy0
Strength of Lower Extremities Secondary · 1 month

-Strength assessment is categorized as follows: 0/5=no contraction (worst); 1/5=muscle flicker, but no movement; 2/5=movement possible, but not against gravity (test the joint in its horizontal plane); 3/5=movement possible against gravity, but not against resistance by the examiner; 4/5=movement possible against some resistance by the examiner; 5/5=normal strength (best)

0=no contraction
GroupValue95% CI
Nab-Paclitaxel and Radiation Therapy0
1=muscle flicker, but no movement
GroupValue95% CI
Nab-Paclitaxel and Radiation Therapy0
2=movement possible, but not against gravity (test the joint in its horizontal plane)
GroupValue95% CI
Nab-Paclitaxel and Radiation Therapy0
3=movement possible against gravity, but not against resistance by the examiner
GroupValue95% CI
Nab-Paclitaxel and Radiation Therapy1
4=movement possible against some resistance by the examiner
GroupValue95% CI
Nab-Paclitaxel and Radiation Therapy0
5=normal strength
GroupValue95% CI
Nab-Paclitaxel and Radiation Therapy0
Pain in the Irradiated Area" Measured on a Scale Secondary · 1 month

-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)

0
GroupValue95% CI
Nab-Paclitaxel and Radiation Therapy0
1
GroupValue95% CI
Nab-Paclitaxel and Radiation Therapy0
2
GroupValue95% CI
Nab-Paclitaxel and Radiation Therapy0
3
GroupValue95% CI
Nab-Paclitaxel and Radiation Therapy0
4
GroupValue95% CI
Nab-Paclitaxel and Radiation Therapy0
5
GroupValue95% CI
Nab-Paclitaxel and Radiation Therapy1
6
GroupValue95% CI
Nab-Paclitaxel and Radiation Therapy0
7
GroupValue95% CI
Nab-Paclitaxel and Radiation Therapy0

Adverse events — posted to ClinicalTrials.gov

Time frame: From start of treatment through 28 days after completion of treatment (estimated to be 6 weeks) . Late toxicities for radiation therapy will be collected for 1 year after the end of radiation therapy (estimated to be 1 year and 2 weeks). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Nab-Paclitaxel and Radiation Therapy
Serious: 1/2 (50%)
Deaths: 2/2

Serious adverse events (2 terms)

ReactionSystemNab-Paclitaxel and Radiati…
ParesthesiaNervous system disorders
Back painMusculoskeletal and connective tissue disorders
Other adverse events (17 terms — click to expand)

ReactionSystemNab-Paclitaxel and Radiati…
Disease progressionGeneral disorders
Blurred visionEye disorders
Abdominal painGastrointestinal disorders
Fecal incontinenceGastrointestinal disorders
FatigueGeneral disorders
ThrushInfections and infestations
Lymphocyte count decreasedInvestigations
White blood cell decreasedInvestigations
HypocalcemiaMetabolism and nutrition disorders
Back painMusculoskeletal and connective tissue disorders
Muscle weakness upper limbMusculoskeletal and connective tissue disorders
MyalgiaMusculoskeletal and connective tissue disorders
Neck painMusculoskeletal and connective tissue disorders
Pain in extremityMusculoskeletal and connective tissue disorders
HeadacheNervous system disorders
HypertensionVascular disorders
Thromboembolic eventVascular disorders

Most-reported serious reactions: Paresthesia, Back pain.

Data from ClinicalTrials.gov NCT03655080 adverse events section.

Sponsor's own description

The purpose of this research study is to look at a combination treatment of radiation therapy and a drug called Abraxane to treat epidural spinal cord compression.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Combining Therapeutic Strategies to Treat the Injured Spinal Cord: A Translational Perspective.
    Sherman BC, Schmidt Read M, Hoh DJ, Guest JD, et al · · 2025 · cited 2× · PMID 40929022 · DOI 10.1177/08977151251371710

Verify or expand the search:

Other trials of Radiation therapy

Trials testing the same drug.

Other Washington University School of Medicine trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03655080.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing