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Dose-intensified Image-Guided Fractionated Radiosurgery for Spinal Metastases (DOSIS)

Phase 2
19 Years
Open (Enrolling)
Neoplasm Metastasis, Neoplastic Processes, Neoplasm Recurrence, Local, Neoplasm, Residual, Pain

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Trial Information

Dose-intensified Image-Guided Fractionated Radiosurgery for Spinal Metastases (DOSIS)

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pain response

Outcome Description:

Pain response 3 months after radiosurgery defined as pain reduction of ≥2 points at the treated vertebral site on the 0 to 10 Visual Analogue Scale without analgesic increase will be defined as pain response

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Matthias Guckenberger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Radiation Oncology, University of Wuerzburg


Germany: The Bavarian State Ministry of the Environment and Public Health

Study ID:




Start Date:

April 2012

Completion Date:

September 2016

Related Keywords:

  • Neoplasm Metastasis
  • Neoplastic Processes
  • Neoplasm Recurrence, Local
  • Neoplasm, Residual
  • Pain
  • Spinal metastases
  • Vertebral metastases
  • Radiosurgery
  • Radiotherapy
  • Stereotactic body radiotherapy
  • Pain
  • Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Neoplasm Recurrence, Local
  • Neoplastic Processes
  • Recurrence
  • Neoplasm, Residual