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

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ClinicalTrials.gov Identifier: NCT02364115
Recruitment Status : Completed
First Posted : February 16, 2015
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Helena M Verkooijen, UMC Utrecht

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

Condition or disease Intervention/treatment Phase
Spinal Metastases Bone Metastases Radiation: Stereotactic Body Radiotherapy Not Applicable

Detailed Description:

Rationale: Bone metastases are a frequent distant manifestation of solid tumours, and many bone metastases are located in the spine. These patients mostly present with severe (back) pain which reduces quality of life. The primary treatment for pain management is a single-fraction low dose external beam radiation therapy (EBRT), effective in achieving pain reduction in around 60% of patients, of whom 0-23% experience complete pain response. Recently, there is growing evidence that Stereotactic Body Radiotherapy (SBRT) achieves a much higher pain response due to the higher dose administered. In retrospective and a few prospective case series, SBRT for spinal, and also non-spinal metastases has been demonstrated to be safe, and efficacious. However, no randomized controlled trials have been performed.

Objective: To study whether the pain response after three months in patients with osseous metastatic disease increases after SBRT in comparison to low dose EBRT.

Study design: Randomized controlled trial, the VERTICAL study, nested within the PRESENT cohort.

Study population: Eligible patients are MRI-compatible patients with radiographic evidence of bone metastases at the radiotherapy department. Fifty-five patients are recruited in both control and intervention arm.

Intervention: Patients will undergo MRI-based, cone beam CT-guided SBRT and will receive 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).

Main study parameters/endpoints: The primary endpoint is pain control at three months after radiotherapy. Secondary outcomes are, among others, the occurrence of vertebral compression fracture (VCF) and radiation-induced myelopathy, local tumour control and evaluation of quality of life.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Conventional Radiotherapy With Stereotactic Body Radiotherapy in Patients With Bone Metastases - VERTICAL Study
Actual Study Start Date : January 2015
Actual Primary Completion Date : May 2019
Actual Study Completion Date : August 2019

Arm Intervention/treatment
Experimental: Stereotactic Body Radiotherapy
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
Other Name: Stereotactic Radiosurgery

No Intervention: Conventional Radiotherapy
Delivery of a single fraction of 8 Gy using virtual simulation



Primary Outcome Measures :
  1. Complete or partial pain response after radiation, defined according to the International Bone Metastases Consensus Endpoints for Clinical Trials. [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. Health-Related Quality of Life [ Time Frame: at 2, 4, 6, 8 weeks, 3 and 6 months, then every 6 months ]
    Self reported quality of life as measured by the Brief Pain Inventory, European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) C15-PAL, and EORTC QLQ BM22

  2. Progression free survival [ Time Frame: up to 3 years ]
    Progression free survival is defined as time between treatment and first sign of progression of disease

  3. Overall survival [ Time Frame: up to 3 years ]
    Overall survival is defined as time between treatment and death from any cause

  4. Occurrence or progression of vertebral compression fracture (VCF) [ Time Frame: up to 12 months ]
    VCF is defined as new endplate fracture or collapse deformity as compared with before SBRT or EBRT

  5. Occurrence of radiation-induced myelopathy [ Time Frame: up to 12 months ]
    Radiation-induced myelopathy is defined as a diagnosis of exclusion and defined as neurological signs and symptoms consistent with radiation damage in the form of necrosis to the segment of the spinal cord irradiated, without MRI evidence of recurrent or progressive tumour affecting the spinal cord.

  6. Duration of pain relief [ Time Frame: at 2, 4, 6, 8 weeks, 3 and 6 months ]
    Duration of pain relief as measured by the Brief Pain Inventory

  7. Determination of rapidity of pain relief [ Time Frame: at 2, 4, 6, 8 weeks, 3 and 6 months ]
    Rapidity of pain relief as measured by the Brief Pain Inventory



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02364115


Locations
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Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
UMC Utrecht
Investigators
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Principal Investigator: Helena M. Verkooijen, MD, PhD UMC Utrecht

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Helena M Verkooijen, Prof. dr., UMC Utrecht
ClinicalTrials.gov Identifier: NCT02364115     History of Changes
Other Study ID Numbers: NL49316.041.14
First Posted: February 16, 2015    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Keywords provided by Helena M Verkooijen, UMC Utrecht:
Spinal metastases
Spinal metastatic disease
Stereotactic Body Radiotherapy
Response
Bone metastases
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases