Randomized Trial Comparing Conventional Radiotherapy With Stereotactic Radiotherapy in Patients With Bone Metastases - VERTICAL Study (VERTICAL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02364115|
Recruitment Status : Completed
First Posted : February 16, 2015
Last Update Posted : September 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spinal Metastases Bone Metastases||Radiation: Stereotactic Body Radiotherapy||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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
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
|University Medical Center Utrecht|
|Utrecht, Netherlands, 3508 GA|
|Principal Investigator:||Helena M. Verkooijen, MD, PhD||UMC Utrecht|