- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02800551
Clinical Trial Comparing Dose-intensified SBRT With Conventional Radiation Therapy for Spinal Metastases (DOSIS RCT)
Dose-intensified Image-guided Fractionated Stereotactic Body Radiation Therapy for Painful Spinal Metastases Versus Conventional Radiation Therapy: a Randomised Controlled Trial (DOSIS RCT)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Indira Madani, Dr.
- Phone Number: +41 44 255 41 08
- Email: indira.madani@usz.ch
Study Contact Backup
- Name: Antonia Schiess
- Phone Number: +41 44 255 41 08
- Email: antonia.schiess@usz.ch
Study Locations
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Zürich, Switzerland, 8091
- UniversitätsSpital Zürich, Klinik für Radio-Onkologie
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: SBRT (Arm A)
dose-intensified image-guided SBRT using simultaneous integrated boost:
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Active Comparator: Conventional Radiation Therapy (Arm B)
External 3-dimensional conformal radiotherapy (3D-CRT): Homogeneous irradiation of the affected vertebra delivering either
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Experimental: SBRT (prospective observational)
Patients eligible for the prospective observational arm will be treated according to the investigational arm (arm A) of the randomised arm of the trial.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local metastasis control
Time Frame: up to 2 years
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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.
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up to 2 years
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Overall survival
Time Frame: up to 2 years
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Overall survival is defined from the day of randomization to a day of death of any cause.
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up to 2 years
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Cancer-specific survival
Time Frame: up to 2 years
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Cancer-specific survival is defined from the day of randomization to a day of death due to cancer progression.
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up to 2 years
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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
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Quality-of-life (QoL) as measured by the EORTC QLQ-C15-PL, EORTC-BM22 and EQ-5D-5L patient reported questionnaires
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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
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Epidural spinal cord compression
Time Frame: up to 2 years
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Epidural spinal cord compression (ESCC) will be scored using Bilsky criteria.
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up to 2 years
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Acute and late toxicity
Time Frame: Acute toxicity: up to 3 months; late toxicity: from 3 months up to 24 months
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Acute aund late toxicity will be assessed in accordance to NCI CTCEA version 4.03 criteria.
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Acute toxicity: up to 3 months; late toxicity: from 3 months up to 24 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Matthias Guckenberger, Prof. Dr., Universitatsspital Zurich
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DOSIS RCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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