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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 May 2023
• Main ID: NCT02800551
• Date of registration: 29/04/2016
• Prospective Registration: Yes
• Primary sponsor: University of Zurich
• Public title: Clinical Trial Comparing Dose-intensified SBRT With Conventional Radiation Therapy for Spinal Metastases DOSIS RCT
• Scientific title: Dose-intensified Image-guided Fractionated Stereotactic Body Radiation Therapy for Painful Spinal Metastases Versus Conventional Radiation Therapy: a Randomised Controlled Trial (DOSIS RCT)
• Date of first enrolment: July 8, 2016
• Target sample size: 219
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02800551
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Switzerland

Contacts

• Name: Matthias Guckenberger, Prof. Dr.
• Affiliation: Universitätsspital Zürich

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Spinal Metastasis

Intervention(s)

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

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

Primary Outcome(s)

Pain response - improvement by = 2 points on the pain Visual Analogue Scale at 6 months post-treatment at the treatment site [Time Frame: 6 months]

Secondary Outcome(s)

Quality-of-life (QoL) [Time Frame: 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]

Local metastasis control [Time Frame: up to 2 years]

Cancer-specific survival [Time Frame: up to 2 years]

Epidural spinal cord compression [Time Frame: up to 2 years]

Acute and late toxicity [Time Frame: Acute toxicity: up to 3 months; late toxicity: from 3 months up to 24 months]

Overall survival [Time Frame: up to 2 years]

Secondary ID(s)

DOSIS RCT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors