A Trial to Improve Quality of Life With Stereotactic Body Radiotherapy for Patients With Painful Bone Metastases (ROBOMET)
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|ClinicalTrials.gov Identifier: NCT03831243|
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : July 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastasis to Bone Radiotherapy Neoplasm Metastasis||Radiation: Stereotactic body radiotherapy Radiation: 3D-conformal radiotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||All subjects will be randomly assigned in a 1:1 ratio to receive either a single fraction of 8.0 Gy to the painful bone metastasis through 3D-CRT (control arm) or a single fraction of 20.0 Gy to the painful bone metastasis through SBRT (experimental arm).|
|Official Title:||A Phase III Randomized-controlled, Single-blind Trial to Improve Quality of Life With Stereotactic Body Radiotherapy for Patients With Painful Bone Metastases|
|Actual Study Start Date :||April 9, 2019|
|Estimated Primary Completion Date :||March 1, 2022|
|Estimated Study Completion Date :||March 1, 2023|
Active Comparator: Single fraction of 8 Gy
The current standard treatment will be prescribed, i.e. a 3D-conformal radiotherapy of a single fraction dose of 8.0 Gy to the metastasis with a planning target volume (PTV) margin for set-up and positioning uncertainties of 1 cm. This can be performed at any linear accelerator.
Radiation: 3D-conformal radiotherapy
In the standard setting, 95% of the PTV should receive 95% of the prescribed dose while near maximum dose (Dnear-max) in the PTV should not exceed 107%. Image-guidance will consist of portal images showing the relevant bony anatomy.
Experimental: Single fraction of 20 Gy
Within the framework of stereotactic body radiotherapy, a single fraction dose of 20.0 Gy will be delivered to the metastasis using a PTV margin of 3-5 mm based on high-precision image-guided radiotherapy (IGRT). Therefore, only linear accelerators with the European Organization for Radiotherapy & Oncology advisory committee on radiation oncology practice (ESTRO-ACROP) specifications for SBRT can be accepted. A risk-adapted approach will be applied, aiming for the highest possible dose no less than 16 Gy, while respecting the tolerances of critical organs at risk (e.g. spinal cord, cauda equina, brainstem etc.).
Radiation: Stereotactic body radiotherapy
Treatment will be prescribed to the periphery of the target, i.e. 80% of the dose should cover 95% of the PTV. The organ at risk (OAR) dose constraints will be in accordance with the recommendations from the report of the American Association of Physicists in Medicine (AAPM) task group 101. Image-guidance will consist of cone-beam CT in combination with 6 degrees of freedom corrections using robotic couch.
- Pain response [ Time Frame: 4 weeks after RT visit ]Pain response at the treated index site at 1 month after radiotherapy (RT), as defined by the consensus statement.
- Incidence of pain flare [ Time Frame: 24-48 hours after radiotherapy ]Number of participants with increase in pain score of 2 or more above baseline at the treated site with stable OMED, or an increase of 25% or more in OMED compared with baseline with the pain score stable or 1 point above baseline
- Duration of pain response [ Time Frame: 2 years after radiotherapy ]Time until pain progression (defined as an increase in pain score of 2 or more above baseline at the treated site with stable daily oral morphine equivalent, or an increase of 25% or more in daily oral morphine equivalent (OMED) compared with baseline with the pain score stable or 1 point above baseline)
- Re-irradiation need [ Time Frame: 2 years after radiotherapy ]Need for re-irradiation of the treated lesion
- Acute toxicity Measured with CTCAE version 5.0 [ Time Frame: 3 months after radiotherapy ]Measured with CTCAE version 5.0
- Late toxicity Measured with CTCAE version 5.0 [ Time Frame: 2 years after radiotherapy ]Measured with CTCAE version 5.0
- Impact of treatment on Quality of Life: EORTC quality of life questionnaire (QLQ) BM22 [ Time Frame: 2 years after radiotherapy ]Using the EORTC quality of life questionnaire for Bone Metastases (QLQ BM22) to measure impact of bone metastases on QoL [min score 0 - max score 100]. A high score represents a high level of symptomatology. The score is calculated by applying a linear transformation on the scores to each answer of the 22 question-long questionnaire (cfr. EORTC mannual).
- Number of Subsequent Serious Skeletal events [ Time Frame: 2 years after radiotherapy ]Incidence of symptomatic pathologic fractures, radiation or surgery to bone, and spinal cord compression.
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): NCT03831243
|Contact: Piet Dirix, MD PhDemail@example.com|
|Contact: Carole Mercier, MDfirstname.lastname@example.org|
|Radiotherapy department, GZA Hospitals||Recruiting|
|Wilrijk, Antwerp, Belgium, 2610|
|Contact: Piet Dirix, MD PhD 003234433737 email@example.com|
|Contact: Carole Mercier, MD 0032344333737 firstname.lastname@example.org|
|Principal Investigator: Piet Dirix, MD PhD|
|Sub-Investigator: Carole Mercier, MD|
|Study Director:||Dirk Verellen, PhD||Iridium Cancer Network|