Bone Metastases Clinical Trial
— VERTICALOfficial title:
Randomized Controlled Trial Comparing Conventional Radiotherapy With Stereotactic Body Radiotherapy in Patients With Bone Metastases - VERTICAL Study
NCT number | NCT02364115 |
Other study ID # | NL49316.041.14 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2015 |
Est. completion date | August 2019 |
Verified date | February 2024 |
Source | UMC Utrecht |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to investigate effectiveness of stereotactic body radiotherapy in patients with bone metastatic disease.
Status | Completed |
Enrollment | 110 |
Est. completion date | August 2019 |
Est. primary completion date | May 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Center Utrecht | Utrecht |
Lead Sponsor | Collaborator |
---|---|
UMC Utrecht |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Health-Related Quality of Life | 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 | at 2, 4, 6, 8 weeks, 3 and 6 months, then every 6 months | |
Secondary | Progression free survival | Progression free survival is defined as time between treatment and first sign of progression of disease | up to 3 years | |
Secondary | Overall survival | Overall survival is defined as time between treatment and death from any cause | up to 3 years | |
Secondary | Occurrence or progression of vertebral compression fracture (VCF) | VCF is defined as new endplate fracture or collapse deformity as compared with before SBRT or EBRT | up to 12 months | |
Secondary | Occurrence of radiation-induced myelopathy | 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. | up to 12 months | |
Secondary | Duration of pain relief | Duration of pain relief as measured by the Brief Pain Inventory | at 2, 4, 6, 8 weeks, 3 and 6 months | |
Secondary | Determination of rapidity of pain relief | Rapidity of pain relief as measured by the Brief Pain Inventory | at 2, 4, 6, 8 weeks, 3 and 6 months |
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