Trial Outcomes & Findings for Pulsed Abraxane and Radiotherapy for Improving and Maintaining Ambulation After Cancer-Related Cord Compression (NCT NCT03655080)

NCT ID: NCT03655080

Last Updated: 2025-02-04

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2025-02-04

Participant Flow

Participant milestones

Measure	Nab-Paclitaxel and Radiation Therapy * 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
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Nab-Paclitaxel and Radiation Therapy n=2 Participants * 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
Age, Continuous	47.5 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: One participant was not evaluable for this outcome measure because the ambulatory status was not completed for the participant.

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

Outcome measures

Measure	Nab-Paclitaxel and Radiation Therapy n=1 Participants * 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
Ambulatory Status Paraplegic	0 Participants
Ambulatory Status Not ambulatory	1 Participants
Ambulatory Status Ambulatory with aid	0 Participants
Ambulatory Status Ambulatory without aid	0 Participants

SECONDARY outcome

Timeframe: 3 months

Population: One participant was not evaluable for this outcome measure because the ambulatory status was not completed for the participant. One participant was not evaluable for this outcome measure because the participant died prior to the 3 month follow-up.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Both participants expired prior to the 6 month follow-up.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 months

Population: Both participants expired prior to the 9 month follow-up.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Both participants expired prior to the 12 month follow-up.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 month

Population: One participant was not evaluable for this outcome measure because the strength of lower extremities was not completed for the participant.

-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)

Outcome measures

Measure	Nab-Paclitaxel and Radiation Therapy n=1 Participants * 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
Strength of Lower Extremities 0=no contraction	0 Participants
Strength of Lower Extremities 1=muscle flicker, but no movement	0 Participants
Strength of Lower Extremities 2=movement possible, but not against gravity (test the joint in its horizontal plane)	0 Participants
Strength of Lower Extremities 3=movement possible against gravity, but not against resistance by the examiner	1 Participants
Strength of Lower Extremities 4=movement possible against some resistance by the examiner	0 Participants
Strength of Lower Extremities 5=normal strength	0 Participants

SECONDARY outcome

Timeframe: 1 month

Population: One participant was not evaluable for this outcome measure because the pain scale was not completed for the participant.

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

Outcome measures

Measure	Nab-Paclitaxel and Radiation Therapy n=1 Participants * 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
Pain in the Irradiated Area" Measured on a Scale 0	0 Participants
Pain in the Irradiated Area" Measured on a Scale 1	0 Participants
Pain in the Irradiated Area" Measured on a Scale 2	0 Participants
Pain in the Irradiated Area" Measured on a Scale 3	0 Participants
Pain in the Irradiated Area" Measured on a Scale 4	0 Participants
Pain in the Irradiated Area" Measured on a Scale 5	1 Participants
Pain in the Irradiated Area" Measured on a Scale 6	0 Participants
Pain in the Irradiated Area" Measured on a Scale 7	0 Participants
Pain in the Irradiated Area" Measured on a Scale 8	0 Participants
Pain in the Irradiated Area" Measured on a Scale 9	0 Participants
Pain in the Irradiated Area" Measured on a Scale 10	0 Participants

SECONDARY outcome

Timeframe: 3 months

Population: One participant was not evaluable for this outcome measure because the pain status was not completed for the participant. One participant was not evaluable for this outcome measure because the participant died prior to the 3 month follow-up.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Both participants expired prior to the 6 month follow-up.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 months

Population: Both participants expired prior to the 9 month follow-up.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Both participants expired prior to the 12 month follow-up.

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

Outcome measures

Outcome data not reported

Adverse Events

Nab-Paclitaxel and Radiation Therapy

Serious events: 1 serious events

Other events: 2 other events

Deaths: 2 deaths

Serious adverse events

Measure	Nab-Paclitaxel and Radiation Therapy n=2 participants at risk * 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
Nervous system disorders Paresthesia	50.0% 1/2 • 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)
Musculoskeletal and connective tissue disorders Back pain	50.0% 1/2 • 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)

Other adverse events

Measure	Nab-Paclitaxel and Radiation Therapy n=2 participants at risk * 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
Eye disorders Blurred vision	50.0% 1/2 • 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)
Gastrointestinal disorders Abdominal pain	50.0% 1/2 • 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)
Gastrointestinal disorders Fecal incontinence	50.0% 1/2 • 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)
General disorders Disease progression	100.0% 2/2 • 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)
General disorders Fatigue	50.0% 1/2 • 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)
Infections and infestations Thrush	50.0% 1/2 • 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)
Investigations Lymphocyte count decreased	50.0% 1/2 • 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)
Investigations White blood cell decreased	50.0% 1/2 • 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)
Metabolism and nutrition disorders Hypocalcemia	50.0% 1/2 • 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)
Musculoskeletal and connective tissue disorders Back pain	50.0% 1/2 • 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)
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	50.0% 1/2 • 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)
Musculoskeletal and connective tissue disorders Myalgia	50.0% 1/2 • 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)
Musculoskeletal and connective tissue disorders Neck pain	50.0% 1/2 • 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)
Musculoskeletal and connective tissue disorders Pain in extremity	50.0% 1/2 • 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)
Nervous system disorders Headache	50.0% 1/2 • 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)
Vascular disorders Hypertension	50.0% 1/2 • 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)
Vascular disorders Thromboembolic event	50.0% 1/2 • 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)

Additional Information

Hiram A. Gay, M.D.

Washington University School of Medicine

Phone: 314-362-8516

Email: hiramgay@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place