Spinal MetastasisPhase 2DOSIS RCTNCT02800551

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

A Phase 2 study testing dose-intensified image-guided SBRT using simultaneous integrated boost and External 3-dimensional conformal radiotherapy (3D-CRT) in people with Spinal Metastasis, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Spinal Metastasis
What is being tested?: dose-intensified image-guided SBRT using simultaneous integrated boost and External 3-dimensional conformal radiotherapy (3D-CRT)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 219 participants
Where: 1 siteSwitzerland
Study dates: 8 Jul 2016to 12 Mar 2024
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 17Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

UniversitätsSpital Zürich, Klinik für Radio-Onkologie
Zurich, 8091

Other trials in Switzerland

About this study

Official title: Dose-intensified Image-guided Fractionated Stereotactic Body Radiation Therapy for Painful Spinal Metastases Versus Conventional Radiation Therapy: a Randomised Controlled Trial (DOSIS RCT)

Read the detailed description

Rationale: Radiation therapy is an effective palliative treatment for painful spinal metastases. A sub-group of patients with mass-type spinal metastases, a factor associated with poor local metastasis control, require treatment optimization ensuring durable pain control and metastatic tumor control.

Proposed solution: To intensify (escalate) radiation dose using simultaneous integrated boost with image-guided hypofractionated SBRT for painful mass-type spinal metastases in a randomized controlled trial. Two experimental fractionation regimes will be tested in the study depending on presence or absence of epidural involvement. Dose intensification is expected to achieve long-term pain control and long-term palliation as well as long-term local metastatic tumor control without adding toxicity as compared to conventional fractionation regimes with conventional radiation therapy.

The study will be carried out as multinational, multicentre phase II clinical controlled trial enrolling patients with painful mass-type spinal metastases who are eligible for radiation therapy without surgery. This study additionally includes a prospective observational arm for patients not eligible for randomisation who are treated in analogy to arm A of the randomised arm.

Conditions: Spinal Metastasis
Being tested: dose-intensified image-guided SBRT using simultaneous integrated boost, External 3-dimensional conformal radiotherapy (3D-CRT)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02800551
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Radiation: dose-intensified image-guided SBRT using simultaneous integrated boost

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (6)

Local metastasis control
Local metastasis control is defined from the day of randomization to a day of local (at the site of the treated spinal metastasis) progression, i.e. local failure, determined on control MR images as a change in signal intensity or on CT images as increasing soft-tissue mass. Increased epidural disease or enlargement of paraspinal disease on control images will be documented as progression.
Measured: up to 2 years
Overall survival
Overall survival is defined from the day of randomization to a day of death of any cause.
Measured: up to 2 years
Cancer-specific survival
Cancer-specific survival is defined from the day of randomization to a day of death due to cancer progression.
Measured: up to 2 years
Quality-of-life (QoL)
Quality-of-life (QoL) as measured by the EORTC QLQ-C15-PL, EORTC-BM22 and EQ-5D-5L patient reported questionnaires
Measured: 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
Epidural spinal cord compression (ESCC) will be scored using Bilsky criteria.
Measured: up to 2 years
Acute and late toxicity
Acute aund late toxicity will be assessed in accordance to NCI CTCEA version 4.03 criteria.
Measured: Acute toxicity: up to 3 months; late toxicity: from 3 months up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jul 201612 Mar 2024

First posted15 Jun 2016 (estimated)
Study start8 Jul 2016
Primary completion13 Jan 2023
Study completion12 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Spinal MetastasisStudies of the same condition, open and under way.
More trials run by University of ZurichThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 219 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02800551
Sponsor's protocol ID: DOSIS RCT
Acronym: DOSIS RCT
Status last verified: Jan 2026
First submitted: 29 Apr 2016
Last updated: 29 Jan 2026
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 40378895

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dose-intensified Image-guided Fractionated Stereotactic Body Radiation Therapy for Painful Spinal Metastases Versus Conventional Radiation Therapy: a Randomised Controlled Trial (DOSIS RCT)
ClinicalTrials.gov ID: NCT02800551
Acronym / sponsor ID: DOSIS RCT / DOSIS RCT
Conditions: Spinal Metastasis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 219 participants (actual)
Lead sponsor: University of ZurichUniversity, hospital or other
Study start: 8 Jul 2016 (actual)
Primary completion: 13 Jan 2023 (actual)
Study completion: 12 Mar 2024 (actual)
First posted: 15 Jun 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
SBRT (Arm A)	Experimental	Radiation: dose-intensified image-guided SBRT using simultaneous integrated boostdose-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.
Conventional Radiation Therapy (Arm B)	Active comparator	Radiation: External 3-dimensional conformal radiotherapy (3D-CRT)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.
SBRT (prospective observational)	Experimental	Radiation: dose-intensified image-guided SBRT using simultaneous integrated boostPatients eligible for the prospective observational arm will be treated according to the investigational arm (arm A) of the randomised arm of the trial.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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%;

Key exclusion criteria (17 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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)

Primary outcome

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

6 secondary outcomes

Local metastasis control
Time frame: up to 2 years
Overall survival
Time frame: up to 2 years
Cancer-specific survival
Time frame: up to 2 years
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
Derived from this study: PubMed 40378895Guckenberger 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Matthias Guckenberger, Prof. Dr. principal investigator

Universitätsspital Zürich

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02800551, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.