Dosisintensivierte Bestrahlung von Wirbelsäulenmetastasen mittels bildgeführter Strahlentherapie (DOSIS) versus konventionelle Strahlentherapie bei schmerzhaften Wirbelsäulenmetastasen

Radiation: dose-intensified image-guided SBRT using simultaneous integrated boost;Radiation: External 3-dimensional conformal radiotherapy (3D-CRT)

Gender: All
Maximum age: N/A
Minimum age: 18 Years

Inclusion Criteria:

- Established histological diagnosis of a malignant primary or metastatic tumor;

- Histologically, radiologically or scintigraphically proven spinal metastasis;

- Pain in the affected spinal region or free of pain under pain medication;

- Age =18 years old;

- Karnofsky performance status =60%;

- Written informed consent.

Exclusion Criteria:

- Modified Bauer Score < 2;

- No-mass-type metastatic lesion, defined as a 3D space-occupying lesion visible on CT
and/or MR;

- "Radiosensitive" histology of the primary tumor, e.g., lymphoma, small-cell lung
cancer, multiple myeloma, germ cell tumors;

- Progressive neurological symptoms/deficit;

- More than 3 affected vertebrae in one target site;

- More than 2 treatment sites;

- Spinal Instability Neoplastic Score (SINS) 13 - 18, i.e., unstable;

- Unable to tolerate treatment (unable to lie flat and immobilized);

- Previous radiotherapy of the region at the level of the affected vertebrae;

- Previous radionuclide therapy within 30 days before stereotactic body radiation
therapy;

- Previous surgery (stabilization) of the affected vertebrae;

- Contraindications for MR scanning, e.g., pacemakers;

- Patients with allergy to contrast agents used in computer tomography (CT) and magnetic
resonance (MR) imaging or patients who cannot be premedicated to use contrast agent;

- Pregnant or lactating women;

- Women of child bearing potential or sexually active males not willing to use effective
contraception while on treatment and 3 months after the end of treatment;

- Mental conditions rendering the patient unable to understand the nature, scope, and
possible consequences of the study;

- Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to
return for follow-up visits, and unlikely to complete the study.