Fractionated Radiosurgery for Painful Spinal Metastases (DOSIS)

Wuerzburg University Hospital

Status: Completed

Conditions: Neoplastic Processes; Neoplasm Metastasis; Neoplasm, Residual; Pain; Neoplasm Recurrence, Local

Treatments: Radiation: Radiosurgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01594892

DOSIS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Dose intensified SBRT

Experimental group

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.

Treatment:

Radiation: Radiosurgery