Pulsed Abraxane and Radiotherapy for Improving and Maintaining Ambulation After Cancer-Related Co… (NCT03655080) | Clinical Trial Compass
TerminatedPhase 2
Pulsed Abraxane and Radiotherapy for Improving and Maintaining Ambulation After Cancer-Related Cord Compression
Stopped: Pharmaceutical company decided to close study
United States2 participantsStarted 2019-01-09
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with ≤ 37 points per the scoring system listed in the protocol
* Histologically or cytologically confirmed diagnosis of cancer not of CNS or spinal column origin.
* MRI or CT evidence of metastatic epidural spinal cord compression.
* Patients who have started 30 Gy in 10 fractions are not excluded as long as 4 doses of chemotherapy could potentially be given. This means the latest nab-paclitaxel can start is the morning of the third fraction of radiotherapy. Radiotherapy should ideally be delivered at least 6 hours after the nab-paclitaxel infusion started.
* At least 18 years of age.
* Normal bone marrow and organ function as defined below:
* Absolute neutrophil count ≥ 1,500 cells/mm3
* Platelets ≥ 100,000 cells/mm3 (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to blood draw)
* Hemoglobin \> 9.0 g/dL
* Total bilirubin ≤ 1.5 mg/dL
* AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN
* Alkaline phosphatase ≤ 2.5 x IULN (unless bone metastasis is present (\< 5 x IULN) in the absence of liver metastasis)
* Creatinine ≤ 1.5 mg/dL
* Women of childbearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy or bilateral oophorectomy or (2) has not been naturally postmenopausal for at least 24 consecutive months) must:
* Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effect…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.