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:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT01594892
Eligibility Criteria:
Inclusion Criteria:
1. Established histological diagnosis of a malignant tumour (primary or metastatic)
2. Vertebral metastasis confirmed via biopsy or radiology
3. Pain in the involved spinal region or free of pain under pain medication
4. Fully consenting patients, \>18 years old
5. Karnofsky Performance Index ≥60%
6. Good or intermediate life expectancy according to the modified prognostic Mizumoto Score (score ≤ 9)
7. Patient must be able to tolerate fixation systems and 30 minutes treatment time
8. Discussed in interdisciplinary tumour board
9. The following types of spinal tumours are eligible:
* Recurrent / residual tumours after surgery
* Tumours in medically inoperable patients or patients deemed inoperable due to limited life expectancy / tumour load
* Lesions associated with significant surgical risk
Exclusion Criteria:
1. Short life expectancy according to the modified Mizumoto Sore
2. "Radiosensitive" histologies (i.e. lymphoma, SCLC, multiple myeloma)
3. Non-ambulatory status
4. Progressive neurological symptoms/deficit
5. \> 3 involved vertebral levels
6. \> 2 treatment sites
7. Spine instability
8. Previous radiotherapy at the involved levels
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT01594892
Study Brief:
Protocol Section:
NCT01594892