Clinical trial · Interventional
Fractionated Radiosurgery for Painful Spinal Metastases
Dose-intensified Image-Guided Fractionated Radiosurgery for Spinal Metastases (DOSIS)
NCT01594892CI-TRIAL-00040391DOSIScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm Metastasis | — | UNRESOLVED | — |
| Neoplasm Recurrence, Local | — | UNRESOLVED | — |
| Neoplasm, Residual | Neoplasm | CURATED_BROADER | 0.78 |
| Neoplastic Processes | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose intensified SBRT
- description
- 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.
- interventionNames
- Radiation: Radiosurgery
Primary outcomes (1)
- measure
- Number of patients, in whom pain is decreased in response to treatment
- timeFrame
- Change in pain from baseline to 3 months post-treatment
- description
- 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 outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDGuckenberger 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. PMID 23164174
- RESULTGuckenberger 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. PMID 29499073
- DERIVEDMantel 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. PMID 31526672