A Phase 2 interventional study of Radiation therapy and nab-Paclitaxel in Cord Compression, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Treatment
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.
52 studies on the registry are indexed under Spinal Cord Compression; 19 are open to participants now.
This study's enrollment of 2 is below the median of 43 across 35 interventional studies indexed under Spinal Cord Compression.
Browse Spinal Cord Compression studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Normal bone marrow and organ function as defined below:
Women of (defined as a sexually mature woman who (1) has not undergone hysterectomy or bilateral oophorectomy or (2) has not been naturally for at least 24 consecutive months) must:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 10 fractions of 3Gy radiation therapy will be delivered. * A total of 4 chemoradiation blocks should be delivered ideally in consecutive days * On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel) * On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day * There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks
Radiation: Radiation therapy · Drug: nab-Paclitaxel
Using the View Ray System
* Dose 15 mg/m\^2 * Should be administered by IV over 30 minutes
Also known as: Abraxane, Albumin-bound paclitaxel
Ambulatory Status
-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.
Time frame: 1 month
Ambulatory Status
-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.
Time frame: 3 months
Ambulatory Status
-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.
Time frame: 6 months
Ambulatory Status
-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.
Time frame: 9 months
Ambulatory Status
-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.
Time frame: 12 months
Strength of Lower Extremities
-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)
Time frame: 1 month
Pain in the Irradiated Area" Measured on a Scale
-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)
Time frame: 1 month
Pain in the Irradiated Area Measured on a Scale
-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)
Time frame: 3 months
Pain in the Irradiated Area Measured on a Scale
-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)
Time frame: 6 months
Pain in the Irradiated Area Measured on a Scale
-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)
Time frame: 9 months
Pain in the Irradiated Area Measured on a Scale
-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)
Time frame: 12 months
| Milestone | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| Started | 2 |
| Completed | 2 |
| Not completed | 0 |
-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.
| Participants | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| Paraplegic | 0 |
| Not ambulatory | 1 |
| Ambulatory with aid | 0 |
| Ambulatory without aid | 0 |
-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.
No measurements were reported for this outcome.
-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.
No measurements were reported for this outcome.
-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.
No measurements were reported for this outcome.
-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.
No measurements were reported for this outcome.
-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)
| Participants | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| 0=no contraction | 0 |
| 1=muscle flicker, but no movement | 0 |
| 2=movement possible, but not against gravity (test the joint in its horizontal plane) | 0 |
| 3=movement possible against gravity, but not against resistance by the examiner | 1 |
| 4=movement possible against some resistance by the examiner | 0 |
| 5=normal strength | 0 |
-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)
| Participants | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| 0 | 0 |
| 1 | 0 |
| 2 | 0 |
| 3 | 0 |
| 4 | 0 |
| 5 | 1 |
| 6 | 0 |
| 7 | 0 |
| 8 | 0 |
| 9 | 0 |
| 10 | 0 |
-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)
No measurements were reported for this outcome.
-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)
No measurements were reported for this outcome.
-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)
No measurements were reported for this outcome.
-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)
No measurements were reported for this outcome.
Collected over 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). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nab-Paclitaxel and Radiation Therapy | 2/2 (100%) | 1/2 (50%) | 2/2 (100%) |
| Event | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| ParesthesiaNervous system disorders | 1/2 |
| Back painMusculoskeletal and connective tissue disorders | 1/2 |
| Event | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| Disease progressionGeneral disorders | 2/2 |
| Blurred visionEye disorders | 1/2 |
| Abdominal painGastrointestinal disorders | 1/2 |
| Fecal incontinenceGastrointestinal disorders | 1/2 |
| FatigueGeneral disorders | 1/2 |
| ThrushInfections and infestations | 1/2 |
| Lymphocyte count decreasedInvestigations | 1/2 |
| White blood cell decreasedInvestigations | 1/2 |
| HypocalcemiaMetabolism and nutrition disorders | 1/2 |
| Back painMusculoskeletal and connective tissue disorders | 1/2 |
| Age, Continuous(years) | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| Median | 47.5 (37 to 58) |
| Sex: Female, Male(Participants) | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| Female | 1 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 2 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| United States | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Albumin-Bound Paclitaxel
Washington University School of Medicine →