Bone MetastasesPhase 2/3NCT01429493
Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases
A Phase 2/3 study testing Conventional Radiotherapy, Biological image-guided radiotherapy with conventional dose. and Biological image-guided SBRT with dose-escalation. in people with Bone Metastases, run by University Hospital, Ghent at 2 sites in Belgium.
Trial summary
In various common cancers, the skeleton is a preferred site of metastasis. These bone metastases are the most common cause of cancer-related pain, which significantly impair quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases
- What is being tested?
- Conventional Radiotherapy, Biological image-guided radiotherapy with conventional dose. and Biological image-guided SBRT with dose-escalation.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesBelgium
- Study dates
- Feb 2013to Dec 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Painful bone metastasis of solid tumors
- Pain score minimum of 2 on a scale of 10
- A maximum number of painful bone metastases: 3 or more
- Life expectancy > 3 months
- Age minimum 18 years old
- Signed informed consent
Who cannot join
- Tumor histology (renal cell and melanoma vs. other solid tumors)
- VAS pain score (<5 vs. 6-10).
- Bisphosphonate use (yes vs. no)
- Opioid analgesics (yes vs. no)
- Corticosteroid use (yes vs. no)
- Spine vs non-spine localisation
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
University Hospital Antwerp
Antwerp
Ghent University Hospital
Ghent, 9000
About this study
Official title: Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases: a Randomized Phase II/III Trial
In various common cancers, the skeleton is a preferred site of metastasis. These bone metastases are the most common cause of cancer-related pain, which significantly impair quality of life. It is postulated that the clinical target volume (CTV) of painful bone metastases consists of cancer cells and tumor-associated host cells: the tumor-host ecosystem. Advances in biological imaging (positron emitting tomography PET) might allow us to selectively identify the tumor-host ecosystem within the anatomical boundaries of a bone metastasis. These findings suggest the potential of intentionally non-homogenous dose escalation (dose painting by numbers) to improve pain control. The hypothesis is that fluorodeoxyglucose positron emitting tomography (FDG-PET) can detect the intra-bone metastasis regions confined with tumor-associated host-cell compartments responsible for metastasis-related pain. The primary objective is to improve pain control with biological image-guided stereotactic body radiotherapy compared to conventional radiotherapy.
- Conditions
- Bone Metastases
- Being tested
- Conventional Radiotherapy, Biological image-guided radiotherapy with conventional dose., Biological image-guided SBRT with dose-escalation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional RadiotherapyRadiation
Conventional radiotherapy will be used (8 Gy/ 1 fraction).
Biological image-guided radiotherapy with conventional dose.Radiation
Biological image-guided radiotherapy on the positron emitting tomography (PET) positive lesion with conventional dose (8Gy/ 1 fraction) will be used.
Biological image-guided SBRT with dose-escalation.Radiation
Biological image-guided stereotactic body radiotherapy (SBRT) with dose-escalation on the PET positive lesion will be used.
| Study group | Role | What they receive |
|---|---|---|
| Conventional radiotherapy | Active comparator | Not described Receives: Radiation: Conventional Radiotherapy |
| Biological image-guided radiotherapy with conventional dose. | Experimental | Not described Receives: Radiation: Biological image-guided radiotherapy with conventional dose. |
| Biological image-guided SBRT with dose-escalation. | Experimental | Not described Receives: Radiation: Biological image-guided SBRT with dose-escalation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of pain response 1 month after radiotherapy
Pain is measured with the visual analogue scale. Response is scored in accordance to the guidelines of the international consensus on palliative radiotherapy.
Measured: 1 month after radiotherapy
Secondary outcomes (1)
Quality of life 1 month after radiotherapy.
Quality of life 1 month after radiotherapy measured with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Bone Metastases Module (QLQ-BM22).
Measured: 1 Month after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startFeb 2013
- Primary completionMay 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wilfried De Neve, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429493
- Sponsor's protocol ID
- 2011/541
- Status last verified
- Dec 2022
- First submitted
- 2 Sep 2011
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases: a Randomized Phase II/III Trial
- ClinicalTrials.gov ID
- NCT01429493
- Acronym / sponsor ID
- 2011/541
- Conditions
- Bone Metastases
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In various common cancers, the skeleton is a preferred site of metastasis. These bone metastases are the most common cause of cancer-related pain, which significantly impair quality of life. It is postulated that the clinical target volume (CTV) of painful bone metastases consists of cancer cells and tumor-associated host cells: the tumor-host ecosystem. Advances in biological imaging (positron emitting tomography PET) might allow us to selectively identify the tumor-host ecosystem within the anatomical boundaries of a bone metastasis. These findings suggest the potential of intentionally non-homogenous dose escalation (dose painting by numbers) to improve pain control. The hypothesis is that fluorodeoxyglucose positron emitting tomography (FDG-PET) can detect the intra-bone metastasis regions confined with tumor-associated host-cell compartments responsible for metastasis-related pain. The primary objective is to improve pain control with biological image-guided stereotactic body radiotherapy compared to conventional radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional radiotherapy | Active comparator | Radiation: Conventional Radiotherapy |
| Biological image-guided radiotherapy with conventional dose. | Experimental | Radiation: Biological image-guided radiotherapy with conventional dose. |
| Biological image-guided SBRT with dose-escalation. | Experimental | Radiation: Biological image-guided SBRT with dose-escalation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Painful bone metastasis of solid tumors
- Pain score minimum of 2 on a scale of 10
- A maximum number of painful bone metastases: 3 or more
- Life expectancy > 3 months
- Age minimum 18 years old
Key exclusion criteria (6 listed)
- Tumor histology (renal cell and melanoma vs. other solid tumors)
- VAS pain score (<5 vs. 6-10).
- Bisphosphonate use (yes vs. no)
- Opioid analgesics (yes vs. no)
- Corticosteroid use (yes vs. no)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional RadiotherapyConventional radiotherapy will be used (8 Gy/ 1 fraction). | Radiation | Conventional radiotherapy |
| Biological image-guided radiotherapy with conventional dose.Biological image-guided radiotherapy on the positron emitting tomography (PET) positive lesion with conventional dose (8Gy/ 1 fraction) will be used. | Radiation | Biological image-guided radiotherapy with conventional dose. |
| Biological image-guided SBRT with dose-escalation.Biological image-guided stereotactic body radiotherapy (SBRT) with dose-escalation on the PET positive lesion will be used. | Radiation | Biological image-guided SBRT with dose-escalation. |
Primary outcome
Level of pain response 1 month after radiotherapy
Time frame: 1 month after radiotherapy
Pain is measured with the visual analogue scale. Response is scored in accordance to the guidelines of the international consensus on palliative radiotherapy.
1 secondary outcome
Quality of life 1 month after radiotherapy.
Time frame: 1 Month after radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilfried De Neve, MD, PhD principal investigator
University Hospital, Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Conventional Radiotherapy, Biological image-guided radiotherapy with conventional dose. and Biological image-guided SBRT with dose-escalation. in people with Bone Metastases, run by University Hospital, Ghent at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of pain response 1 month after radiotherapy (time frame: 1 month after radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.