Clinical Trial Comparing Dose-intensified SBRT With Conventional Radiation Therapy for Spinal Metastases

NCT02800551 | Completed Phase 2

• 1 other identifier: DOSIS RCT
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare pain (primary end-point) and local metastatic tumor control (secondary end-point) after dose-intensified image-guided fractionated stereotactic body radiation therapy (SBRT) for painful mass-type spinal metastases versus conventional radiation therapy.

Conditions

Spinal Metastasis

Outcome Measures

Primary Outcomes (1)

• Pain response - improvement by ≥ 2 points on the pain Visual Analogue Scale at 6 months post-treatment at the treatment site

  6 months

Secondary Outcomes (6)

• Local metastasis control

  up to 2 years

• Overall survival

  up to 2 years

• Cancer-specific survival

  up to 2 years

• Quality-of-life (QoL)

  Day 1 and last day of treatment (usually day5 if Radiotherapy is delivered in 5 fractions, and day 12 if Radiotherapy is delivered in 10 fractions); months 1, 3, 6, 9, 12, 18 and 24

• Epidural spinal cord compression

  up to 2 years

Study Arms (3)

SBRT (Arm A)

EXPERIMENTAL

dose-intensified image-guided SBRT using simultaneous integrated boost: * in the case of no epidural involvement: 40 Gy and 20 Gy in 5 fractions to the high-dose and conventional-dose target volume, respectively. * In the case epidural involvement: 48.5 Gy and 30 Gy in 10 fractions to the high-dose and conventional-dose target volume, respectively.

Radiation: dose-intensified image-guided SBRT using simultaneous integrated boost

Conventional Radiation Therapy (Arm B)

ACTIVE COMPARATOR

External 3-dimensional conformal radiotherapy (3D-CRT): Homogeneous irradiation of the affected vertebra delivering either * 20 Gy in 5 fractions or * 30 Gy in 10 fractions.

Radiation: External 3-dimensional conformal radiotherapy (3D-CRT)

SBRT (prospective observational)

EXPERIMENTAL

Patients eligible for the prospective observational arm will be treated according to the investigational arm (arm A) of the randomised arm of the trial.

Radiation: dose-intensified image-guided SBRT using simultaneous integrated boost

Interventions

dose-intensified image-guided SBRT using simultaneous integrated boost RADIATION

SBRT (Arm A); SBRT (prospective observational)

External 3-dimensional conformal radiotherapy (3D-CRT) RADIATION

Conventional Radiation Therapy (Arm B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

UniversitätsSpital Zürich, Klinik für Radio-Onkologie

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Guckenberger M, Wilke L, Billiet C, Rogers S, Franzese C, Schnell D, Spalek M, Aebersold DM, Hemmatazad H, Zilli T, Boda-Heggemann J, Baumert BG, Stelmes JJ, Nagler F, Gut P, Weiss C, Bruni A, Zimmermann F, Forster R, Zimmer J, Madani I. Dose-intensified SBRT for vertebral oligometastases: results from a prospective clinical trial. Radiother Oncol. 2025 Jul;208:110940. doi: 10.1016/j.radonc.2025.110940. Epub 2025 May 14.

  PMID: 40378895 DERIVED

MeSH Terms

Interventions

Radiotherapy, Conformal

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Matthias Guckenberger, Prof. Dr.

  Universitätsspital Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: June 15, 2016
• Study Start: July 8, 2016
• Primary Completion: January 13, 2023
• Study Completion: March 12, 2024
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)