NCT03655080终止2 期
Novel Approach of Pulsed Abraxane and Radiotherapy for Improving and Maintaining Ambulation After Cancer-Related Cord Compression
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Ambulatory Status
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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, effective contraception without interruption, 28 days prior to starting treatment with nab-paclitaxel and while on study; and
- •Have a negative serum pregnancy test result at screening and agree to ongoing pregnancy testing during the course of the study and after the end of study therapy. This applies even if the subject practices true abstinence from heterosexual contact.
- •Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for 6 months following nab-paclitaxel discontinuation, even if he has undergone a successful vasectomy.
- •Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
排除标准
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- •Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test prior to study entry.
- •Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with nab-paclitaxel. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
- •Previous spinal cord radiotherapy that would overlap with the proposed treatment field.
- •Spinal instability or bony retropulsion causing the cord compression. That is, mechanical, not tumor, cord compression. In these cases surgery may be indicated.
- •Patients eligible for surgical decompression like laminectomy.
研究组 & 干预措施
nab-Paclitaxel and Radiation Therapy
Experimental
- 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
干预措施: Radiation therapy (Radiation)
nab-Paclitaxel and Radiation Therapy
Experimental
- 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
干预措施: nab-Paclitaxel (Drug)
结局指标
主要结局
Ambulatory Status
时间窗: 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.
次要结局
- Ambulatory Status(12 months)
- Strength of Lower Extremities(1 month)
- Pain in the Irradiated Area" Measured on a Scale(1 month)
- Pain in the Irradiated Area Measured on a Scale(12 months)
研究者
研究点 (1)
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