Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT01391234
Eligibility Criteria:
Inclusion Criteria:
* Patient has a biopsy proven diagnosis of cancer. The osseous metastatic lesions do not need to be biopsied.
* Patients with multiple myeloma are eligible for the study.
* Patient has 1-3 major painful osseous metastases (target lesions) from any primary cancer or unknown primary cancer.
* Long bone target lesions must have a Mirels fracture score of ≤ 7.
* Patients with spinal cord compression from vertebral body metastases are not eligible.
* Target lesions have not previously been treated with radiation.
* Radiation oncologist determines that the patient is medically able to undergo palliative radiation therapy.
* Patient has target lesions that are radiographically consistent with metastatic disease on CT, MR, or PET CT obtained within 8 weeks of treatment.
* Persistent distinguishable pain associated with target sites to be treated.
* Patient average BPI pain score for last 72 hours at specified location is \> 3 (0-10 scale)
* Patients may have additional non-painful or minimally painful osseous metastases (if patient has pain from additional sites, the pain from the additional sites must be evaluated as being less intense by at least 2 points on the BPI compared to the site(s) treated)
* The patient may have previously been treated with radiation therapy to other body sites, but not to the target lesions.
* The patient may have previously or currently be undergoing chemotherapy or bisphosphonate therapy.
* The patient will be able understand English (or a medical interpreter for their native language must be available for all study visits).
* 18 years of age or older.
* Life expectancy \> 12 weeks.
* Able and willing to answer simple survey questionnaires.
* Able and willing to keep a logbook of analgesic use (with or without assistance).
* Willing to return to clinic for follow-up visits after first treatment.
* Signed study-specific informed consent form
Exclusion Criteria:
* Inability to lie flat on table for treatment
* Patient with \< 12 weeks life expectancy
* Systemic radionuclide delivery within 30 days prior to treatment
* Epidural compression of spinal cord or cauda equine
* Spinal canal compromise \> 25%
* Unstable spine requiring surgical stabilization
* Target lesions have previously been treated with radiation.
* Tumor located within 5mm of spinal cord or cauda equina.
* A serious uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the patient to receive protocol therapy.
* Pregnant and breastfeeding women are excluded from this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01391234
Study Brief:
Protocol Section:
NCT01391234