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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 : Recruiting
First Posted : February 16, 2015
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Helena M Verkooijen, UMC Utrecht

Tracking Information
First Submitted Date  ICMJE February 1, 2015
First Posted Date  ICMJE February 16, 2015
Last Update Posted Date May 4, 2018
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02364115 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2015)
  • 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
  • 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
  • Overall survival [ Time Frame: up to 3 years ]
    Overall survival is defined as time between treatment and death from any cause
  • 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
  • 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.
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Trial Comparing Conventional Radiotherapy With Stereotactic Radiotherapy in Patients With Bone Metastases - VERTICAL Study
Official Title  ICMJE Randomized Controlled Trial Comparing Conventional Radiotherapy With Stereotactic Body Radiotherapy in Patients With Bone Metastases - VERTICAL Study
Brief Summary The purpose of the study is to investigate effectiveness of stereotactic body radiotherapy in patients with bone metastatic disease.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Spinal Metastases
  • Bone Metastases
Intervention  ICMJE Radiation: Stereotactic Body Radiotherapy
Other Name: Stereotactic Radiosurgery
Study Arms  ICMJE
  • 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).
    Intervention: Radiation: Stereotactic Body Radiotherapy
  • No Intervention: Conventional Radiotherapy
    Delivery of a single fraction of 8 Gy using virtual simulation
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 13, 2015)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Joanne M. van der Velden, MD +31(0)887550803 j.m.vandervelden@umcutrecht.nl
Contact: Enrica Seravalli, PhD e.seravalli@umcutrecht.nl
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02364115
Other Study ID Numbers  ICMJE NL49316.041.14
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Helena M Verkooijen, UMC Utrecht
Study Sponsor  ICMJE UMC Utrecht
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Helena M. Verkooijen, MD, PhD UMC Utrecht
PRS Account UMC Utrecht
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP