Randomized Trial Comparing Conventional Radiotherapy With Stereotactic Radiotherapy in Patients With Bone Metastases - VERTICAL Study

NCT02364115 | Completed DMC

• 1 other identifier: NL49316.041.14
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to investigate effectiveness of stereotactic body radiotherapy in patients with bone metastatic disease.

Conditions

Spinal Metastases; Bone Metastases

Keywords

Spinal metastases; Spinal metastatic disease; Stereotactic Body Radiotherapy; Response; Bone metastases

Outcome Measures

Primary Outcomes (1)

• Complete or partial pain response after radiation, defined according to the International Bone Metastases Consensus Endpoints for Clinical Trials.

  The primary endpoint of this study is complete or partial pain response after SBRT or EBRT after three months. Complete and partial response, but also possible pain progression or indeterminate response, will be defined according to the International Bone Metastases Consensus Endpoints for Clinical Trials.

  3 months

Secondary Outcomes (7)

• Health-Related Quality of Life

  at 2, 4, 6, 8 weeks, 3 and 6 months, then every 6 months

• Progression free survival

  up to 3 years

• Overall survival

  up to 3 years

• Occurrence or progression of vertebral compression fracture (VCF)

  up to 12 months

• Occurrence of radiation-induced myelopathy

  up to 12 months

Study Arms (2)

Stereotactic Body Radiotherapy

EXPERIMENTAL

MRI-based, cone beam CT-guided SBRT delivery of a single dose of 18 Gray (Gy) on the visible metastasis, and 8 Gy on the bony compartment containing the metastasis (e.g. the affected vertebra or pedicle).

Radiation: Stereotactic Body Radiotherapy

Conventional Radiotherapy

NO INTERVENTION

Delivery of a single fraction of 8 Gy using virtual simulation

Interventions

Stereotactic Body Radiotherapy RADIATION

Also known as: Stereotactic Radiosurgery

Stereotactic Body Radiotherapy

Eligibility Criteria

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

You may qualify if:

• Radiographic evidence of bone metastases
• For spinal lesions; per lesion no more than 3 consecutive spine segments involved with one unaffected vertebral body above and below
• No more than 2 painful lesions needing treatment
• Histologic proof of malignancy
• No compression of spinal cord
• No or mild neurological signs (i.e. radiculopathy, dermatomal sensory change, and muscle strength of involved extremity is Medical Research Council (MRC) 4/5
• Medically inoperable or patient refused surgery
• Karnofsky performance score (KPS) \> 50
• Numeric rating scale (NRS) \> 3
• Age \> 18 years
• Written informed consent
• Filling out PRESENT-questionnaires

You may not qualify if:

• Lesion in C1 or C2
• Radio-sensitive histology such as multiple myeloma, lymphoma, small cell, germ cell
• Spinal MRI cannot be completed for any reason (in according with the MRI protocol of the Department of Radiology)
• Impossible to delineate metastasis and organs at risk (OAR) due to artifacts on CT or MRI from previous surgical stabilization
• Unable to undergo SBRT treatment, according to treating doctor's opinion
• Epidural disease
• Severe, worsening or progressive neurological deficit
• Unstable lesion requiring surgical stabilization
• Patient with \< 3 months life expectancy
• Previous EBRT or SBRT to same level
• Chemotherapy or systemic radionuclide delivery within 24 hours before and after SBRT

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3508 GA, Netherlands

Location

Related Publications (2)

• Pielkenrood BJ, van der Velden JM, van der Linden YM, Bartels MMT, Kasperts N, Verhoeff JJC, Eppinga WSC, Gal R, Verlaan JJ, Verkooijen HML. Pain Response After Stereotactic Body Radiation Therapy Versus Conventional Radiation Therapy in Patients With Bone Metastases-A Phase 2 Randomized Controlled Trial Within a Prospective Cohort. Int J Radiat Oncol Biol Phys. 2021 Jun 1;110(2):358-367. doi: 10.1016/j.ijrobp.2020.11.060. Epub 2020 Dec 14.

  PMID: 33333200 DERIVED

• van der Velden JM, Verkooijen HM, Seravalli E, Hes J, Gerlich AS, Kasperts N, Eppinga WS, Verlaan JJ, van Vulpen M. Comparing conVEntional RadioTherapy with stereotactIC body radiotherapy in patients with spinAL metastases: study protocol for an randomized controlled trial following the cohort multiple randomized controlled trial design. BMC Cancer. 2016 Nov 21;16(1):909. doi: 10.1186/s12885-016-2947-0.

  PMID: 27871280 DERIVED

Related Links

• Related Info

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Helena M. Verkooijen, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: February 1, 2015
• First Posted: February 16, 2015
• Study Start: January 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: August 1, 2019
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

NL (1)