Neoplasm Metastasis, Neoplasm Recurrence, Local, Neoplasm, Residual, Neoplastic Processes, Pain
Conditions
Keywords
Spinal metastases, Vertebral metastases, Radiosurgery, Radiotherapy, Stereotactic body radiotherapy, Pain
Brief summary
It is the study hypothesis that hypo-fractionated image-guided radiosurgery significantly improves pain relief compared to historic data of conventionally fractionated radiotherapy. Primary endpoint is pain response 3 months after radiosurgery, which is defined as pain reduction of ≥2 points at the treated vertebral site on the 0 to 10 Visual Analogue Scale. 60 patients will be included into this II trial.
Detailed description
The current study will investigate efficacy and safety of radiosurgery for painful vertebral metastases and three characteristics will distinguish this study. 1. A prognostic score for overall survival will be used for selection of patients with longer life expectancy to allow for analysis of long-term efficacy and safety. 2. Fractionated radiosurgery will be performed with the number of treatment fractions adjusted to either good (10 fractions) or intermediate (5 fractions) life expectancy. Fractionation will allow inclusion of tumors immediately abutting the spinal cord due to higher biological effective doses at the tumor - spinal cord interface compared to single fraction treatment. 3. Dose intensification will be performed in the involved parts of the vertebrae only, while uninvolved parts are treated with conventional doses using the simultaneous integrated boost concept.
Interventions
RADIATIONRadiosurgery
Fractionated radiosurgery using intensity-modulated treatment planning and volumetric image-guided treatment delivery
Sponsors
Royal Marsden NHS Foundation Trust
Wuerzburg University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Evaluation of the single intervention - dose-intensified SBRT
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients, in whom pain is decreased in response to treatment | Change in pain from baseline to 3 months post-treatment | Decrease in pain by ≥2 points at the treated vertebral site on the 0 (no pain) to 10 (the severest pain) Visual Analogue Scale without analgesic increase |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 2 years | Death from any cause |
| Patient-assessed 5 dimensions of patient's quality-of-life | Changes in quality of life from baseline to 3 months post-treatment | Measured with the 5-level (no problems, slight problems, moderate problems, severe problems, and extreme problems) EuroQol 5-Dimension Questionnaire (EQ-5D) questionnaire |
| Local tumor control | 2 years | At the treated vertebral levels assessed with MRI |
| Number of patients developing acute toxicity | Changes from baseline up to 6 weeks post-treatment | Measured with NCI CTCAE v 4.0 |
| Number of patients developing late toxicity | Changes from >6weeks up to 2 years post-treatment | Measured with NCI CTCAE v 4.0 |
| Patient-assessed overall health status | Changes in quality of life from baseline to 3 months post-treatment | Measured with the EuroQol Visual Analog Scale from 0 (the worst health you can imagine) to 100 (the best health you can imagine) |
Countries
Germany, Netherlands, Switzerland, United Kingdom
Outcome results
None listed