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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57706

Enrollment

Registered

2013-09-23

Start date

2014-03-27

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pain control radiotherapy vertebral metastases

Interventions

Based on stratification on predicted life expectancy using the modified Mizumoto Score, patients will be divided in 2 cohorts: Arm A long life expectancy with Mizumoto score 0 - 4: 10 x 3Gy (PTV-elec

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: . malignant tumor . vertebral metastases . pain in the involved spinal region . KI >

Exclusion criteria

Exclusion criteria: . Short life expectancy . radiosensitive histologies . progressive neurological symptoms . > 3 involved vertebral levels . > 2 treatment sites . pregnancy

Design outcomes

Primary

Measure	Time frame
Primary endpoints: Pain response: pain control is defined as complete response or partial response on the 10 points pain Visual Analogue Scale (VAS) score	—

Secondary

Measure	Time frame
Secondary endpoints: Local control will be defined by repeat imaging (preferably MRT or CT) at 3, 6, 12, 18 and 24 months. Toxicity of treatment will be graded according to the NCI-CTCAE, version 4.0	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)