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| Name | Class |
|---|---|
| Royal Marsden NHS Foundation Trust | OTHER |
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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.
The current study will investigate efficacy and safety of radiosurgery for painful vertebral metastases and three characteristics will distinguish this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose intensified SBRT | Experimental | Depending on the modified Mizumoto Score (0-4 points or 5-9 points) patients will be treated with 10 fractions of 4.85Gy in involved parts of the vertebra and 3Gy in not-involved parts using a simultaneous integrated boost or with 5 fractions of 7Gy in involved parts of the vertebra and 4Gy in not-involved parts using a simultaneous integrated boost, respectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiosurgery | Radiation | Fractionated radiosurgery using intensity-modulated treatment planning and volumetric image-guided treatment delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients, in whom pain is decreased in response to 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 | Change in pain from baseline to 3 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Local tumor control | At the treated vertebral levels assessed with MRI | 2 years |
| Local tumor control | At the treated vertebral levels assessed with CT imaging |
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Inclusion Criteria:
Established histological diagnosis of a malignant tumour (primary or metastatic)
Vertebral metastasis confirmed via biopsy or radiology
Pain in the involved spinal region or free of pain under pain medication
Fully consenting patients, >18 years old
Karnofsky Performance Index ≥60%
Good or intermediate life expectancy according to the modified prognostic Mizumoto Score (score ≤ 9)
Patient must be able to tolerate fixation systems and 30 minutes treatment time
Discussed in interdisciplinary tumour board
The following types of spinal tumours are eligible:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Guckenberger, MD | Department of Radiation Oncology, University of Wuerzburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leopoldina Schweinfurt | Schweinfurt | Germany | ||||
| Department of Radiation Oncology, University of Wuerzburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23164174 | Background | Guckenberger M, Hawkins M, Flentje M, Sweeney RA. Fractionated radiosurgery for painful spinal metastases: DOSIS - a phase II trial. BMC Cancer. 2012 Nov 19;12:530. doi: 10.1186/1471-2407-12-530. | |
| 29499073 | Result | Guckenberger M, Sweeney RA, Hawkins M, Belderbos J, Andratschke N, Ahmed M, Madani I, Mantel F, Steigerwald S, Flentje M. Dose-intensified hypofractionated stereotactic body radiation therapy for painful spinal metastases: Results of a phase 2 study. Cancer. 2018 May 1;124(9):2001-2009. doi: 10.1002/cncr.31294. Epub 2018 Mar 2. |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D009364 | Neoplasm Recurrence, Local |
| D018365 | Neoplasm, Residual |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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Evaluation of the single intervention - dose-intensified SBRT
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| 2 years |
| Overall survival | Death from any cause | 2 years |
| Patient-assessed 5 dimensions of patient's quality-of-life | Measured with the 5-level (no problems, slight problems, moderate problems, severe problems, and extreme problems) EuroQol 5-Dimension Questionnaire (EQ-5D) questionnaire | Changes in quality of life from baseline to 3 months post-treatment |
| Patient-assessed overall health status | Measured with the EuroQol Visual Analog Scale from 0 ("the worst health you can imagine") to 100 (the best health you can imagine") | Changes in quality of life from baseline to 3 months post-treatment |
| Number of patients developing acute toxicity | Measured with NCI CTCAE v 4.0 | Changes from baseline up to 6 weeks post-treatment |
| Number of patients developing late toxicity | Measured with NCI CTCAE v 4.0 | Changes from >6weeks up to 2 years post-treatment |
| Würzburg |
| 97080 |
| Germany |
| Netherlands Cancer Institute | Amsterdam | Netherlands |
| University Hospital Zurich | Zurich | Switzerland |
| The Royal Marsden Hospital NHS Foundation Trust | Sutton | SM2 5PT | United Kingdom |
| 31526672 | Derived | Mantel F, Sweeney RA, Klement RJ, Hawkins MA, Belderbos J, Ahmed M, Toussaint A, Polat B, Flentje M, Guckenberger M. Risk factors for vertebral compression fracture after spine stereotactic body radiation therapy: Long-term results of a prospective phase 2 study. Radiother Oncol. 2019 Dec;141:62-66. doi: 10.1016/j.radonc.2019.08.026. Epub 2019 Sep 13. |
| D012816 | Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |