Spine MetastasesRadiointerNCT02174107
Health Economics Evaluation of Percutaneous Vertebroplasty Compared to Radiation Therapy in Patients With Painful Spine Metastases.
A study testing External radiotherapy and Percutaneous vertebroplasty in people with Spine Metastases, run by Centre Leon Berard at 7 sites in France.
Trial summary
The purpose of this study is to evaluate cost-utility analysis in order to provide recommendations to French decision-makers between vertebroplasty and radiation therapy in Bone spine metastases. Indeed, radiation therapy is often advocated a systematic way. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Metastases
- What is being tested?
- External radiotherapy and Percutaneous vertebroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 7 sitesFrance
- Study dates
- Apr 2015to Apr 2018
- Phase
- Interventional
- 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
- Age ≥ 18 years at the day of consenting to the study
- Patient with at least a painful spine metastasis confirmed by MRI / CT scan,
- Localized pain at the lesion ≥ 4 (VAS),
- Bone axial metastasis localised on ≤ 6 different vertebrae,
- Histologically established diagnosis of cancer (lung, kidney, breast, prostate, melanoma, soft tissue sarcomas) other than hematologic malignancy, myeloma, brain tumor, germ cell tumor and bone sarcomas
- ECOG performance status 0 to 2 (Appendix 2)
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- Minimum life expectancy of 6 months (Tokuhashi score > 8 )
- Ability to understand and willingness for follow-up visits.
- Covered by a medical insurance
- Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrolment
Who cannot join
- Solitary metastasis
- SBRT indication
- Contra-indication to vertebroplasty
- Previous radiotherapy for pain management in the same area.
- Patient unable to lie prone
- Neurological deficit due to spinal cord compression,
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- Active infection,
- Bleeding risk (platelets < 50000 and PTT > 1.5*ULN),
- Risk of vertebral collapse (SINS score ≥ 13),
- Impossible follow-up for social, geographical, familial or psychological reasons,
- Patient deprived of freedom,
- Patient enrolled in another experimental surgical trial, with therapeutic endpoint,
- Pregnant or breastfeeding women,Pregnant or breastfeeding women (mandatory negative serum or urinary pregnancy test at study entry for all women of childbearing potential
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Institut Bergonié
Bordeaux
Centre Leon Berard
Lyon
HCL- Hopital Edouard Herriot
Lyon
Centre Antoine Lacassagne
Nice
Institut Curie
Paris
Centre Paul Strauss
Strasbourg
Institut Gustave Roussy
Villejuif
About this study
The purpose of this study is to evaluate cost-utility analysis in order to provide recommendations to French decision-makers between vertebroplasty and radiation therapy in Bone spine metastases. Indeed, radiation therapy is often advocated a systematic way. The object of this study would be to expand the use of vertebroplasty.
Moreover, this study assess to the strategy impact on the pain control reduction and functional preservation. In fact, analgesic effect is achieved differently depending on the procedure used.Eligible patients will be recruited and registered consecutively. Patients will be randomly,
Read more
This is a health-economic multicenter, prospective, randomized with stratification according to number of vertebrae to treat (1-3 vertebrae vs 4-6 vertebrae) and center :
- Arm A: Percutaneous vertebroplasty
- Arm B: External radiotherapy
This is an open-label study. The expected total study period is 2.5 years (enrolment: 2 years, patient follow-up: 6 months). A total number of 304 patients with spine metastases will be recruited (152 patients/arm).
Read the detailed description
Bone is the most common site for metastasis. In breast and prostate cancers, 70% of patients dying of their cancer have evidence of metastatic bone disease [Coleman, 2006]. Depending on their localization, bone metastases can have debilitating consequences resulting in considerable morbidity and complex demands on health care resources. Bone spine metastases are the most frequent site observed in patients with cancer of the lung, prostate, breast and hemopoetic organs. The occurrence of spinal metastases in patients with advanced cancer can cause significant morbidity, with pain and/or neurological deficit adversely affecting the patients' quality of life.
Interventional radiology takes a large place in the treatment of bone metastases. Currently, vertebroplasty appears as the most satisfactory technique for stabilization of spine metastases offering a significant improvement of the quality of life. The analgesic effect is achieved very rapidly, i.e. usually within 24 hours post-procedure. Based on several publications, around 90% of patients reported rapid pain relief following vertebroplasty with 60 to 70% of complete pain relief [Mendel, 2009].
Radiotherapy also plays a very important role in the palliative treatment of the metastatic bone. Radiotherapy is effective and well tolerated. A reduction of the pain is noticed for 70 to 80 % of the patients and begins one or two weeks after the treatment. In all, the radiotherapy increases the quality of life of the patients and can reduce the intake of analgesics [Lutz, 2011].
In a lot of cases, vertebroplasty or radiotherapy can both be performed for a same painful patient (the National Institute for Health and Clinical Excellence (NICE) approved the use of vertebroplasty for patients with spinal metastases in November 2008). Radiotherapy remains the gold-standard treatment. However, vertebroplasty could be less costly and more effective compare to radiotherapy. In fact, the superiority of vertebroplasty has been demonstrated at least in the acute post-therapeutic period with (i) more rapid autonomy recovery, (ii) reduction of antalgic intakes, and potentially less side-effects.
- Conditions
- Spine Metastases
- Being tested
- External radiotherapy, Percutaneous vertebroplasty
- Keywords
- Health economics, Percutaneous vertebroplasty, Radiation therapy, Painful spine metastases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External radiotherapyRadiation
The radiation technique used for each patient will be based on local clinical practices and on number of vertebae to treat between 1*8 Gy; 5*4 Gy and 10*3 Gy
Percutaneous vertebroplastyProcedure or surgery
Also called Vertebroplasty
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Percutaneous vertebroplasty Receives: Procedure: Percutaneous vertebroplasty |
| Arm B | Experimental | External radiotherapy Receives: Radiation: External radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health economics evaluation
To perform a cost-utility analysis in order to provide recommendations to French decision-makers on the treatment of patients with painful spine metastases.
Incremental cost-effectiveness ratio expressed in cost per quality adjusted life year (QALY) gained
Measured: 6 months after the end ot treatment
Secondary outcomes (1)
Budget impact analysis of vertebroplasty
Cost-assessment, Quality of life (EQ-5D) Quality adjusted life year,
Measured: 6 months after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startApr 2015
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Why it stopped: recruitment issues due to feasability issues in centers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine MetastasesStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand BR RICHIOUD, MD, Principal investigator, Center Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174107
- Sponsor's protocol ID
- RADIOINTER01
- Acronym
- Radiointer
- Status last verified
- Jan 2017
- First submitted
- 24 Jun 2014
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Economics Evaluation of Percutaneous Vertebroplasty Compared to Radiation Therapy in Patients With Painful Spine Metastases.
- ClinicalTrials.gov ID
- NCT02174107
- Acronym / sponsor ID
- Radiointer / RADIOINTER01
- Conditions
- Spine Metastases
- Keywords
- Health economics, Percutaneous vertebroplasty, Radiation therapy, Painful spine metastases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment issues due to feasability issues in centers
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 25 Jun 2014 (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.
The purpose of this study is to evaluate cost-utility analysis in order to provide recommendations to French decision-makers between vertebroplasty and radiation therapy in Bone spine metastases. Indeed, radiation therapy is often advocated a systematic way. The object of this study would be to expand the use of vertebroplasty.
Moreover, this study assess to the strategy impact on the pain control reduction and functional preservation. In fact, analgesic effect is achieved differently depending on the procedure used.Eligible patients will be recruited and registered consecutively. Patients will be randomly,
This is a health-economic multicenter, prospective, randomized with stratification according to number of vertebrae to treat (1-3 vertebrae vs 4-6 vertebrae) and center :
- Arm A: Percutaneous vertebroplasty
- Arm B: External radiotherapy
This is an open-label study. The expected total study period is 2.5 years (enrolment: 2 years, patient follow-up: 6 months). A total number of 304 patients with spine metastases will be recruited (152 patients/arm).
Detailed description
Bone is the most common site for metastasis. In breast and prostate cancers, 70% of patients dying of their cancer have evidence of metastatic bone disease [Coleman, 2006]. Depending on their localization, bone metastases can have debilitating consequences resulting in considerable morbidity and complex demands on health care resources. Bone spine metastases are the most frequent site observed in patients with cancer of the lung, prostate, breast and hemopoetic organs. The occurrence of spinal metastases in patients with advanced cancer can cause significant morbidity, with pain and/or neurological deficit adversely affecting the patients' quality of life.
Interventional radiology takes a large place in the treatment of bone metastases. Currently, vertebroplasty appears as the most satisfactory technique for stabilization of spine metastases offering a significant improvement of the quality of life. The analgesic effect is achieved very rapidly, i.e. usually within 24 hours post-procedure. Based on several publications, around 90% of patients reported rapid pain relief following vertebroplasty with 60 to 70% of complete pain relief [Mendel, 2009].
Radiotherapy also plays a very important role in the palliative treatment of the metastatic bone. Radiotherapy is effective and well tolerated. A reduction of the pain is noticed for 70 to 80 % of the patients and begins one or two weeks after the treatment. In all, the radiotherapy increases the quality of life of the patients and can reduce the intake of analgesics [Lutz, 2011].
In a lot of cases, vertebroplasty or radiotherapy can both be performed for a same painful patient (the National Institute for Health and Clinical Excellence (NICE) approved the use of vertebroplasty for patients with spinal metastases in November 2008). Radiotherapy remains the gold-standard treatment. However, vertebroplasty could be less costly and more effective compare to radiotherapy. In fact, the superiority of vertebroplasty has been demonstrated at least in the acute post-therapeutic period with (i) more rapid autonomy recovery, (ii) reduction of antalgic intakes, and potentially less side-effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Procedure: Percutaneous vertebroplastyPercutaneous vertebroplasty |
| Arm B | Experimental | Radiation: External radiotherapyExternal radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years at the day of consenting to the study
- Patient with at least a painful spine metastasis confirmed by MRI / CT scan,
- Localized pain at the lesion ≥ 4 (VAS),
- Bone axial metastasis localised on ≤ 6 different vertebrae,
- Histologically established diagnosis of cancer (lung, kidney, breast, prostate, melanoma, soft tissue sarcomas) other than hematologic malignancy, myeloma, brain tumor, germ cell tumor and bone sarcomas
Key exclusion criteria (13 listed)
- Solitary metastasis
- SBRT indication
- Contra-indication to vertebroplasty
- Previous radiotherapy for pain management in the same area.
- Patient unable to lie prone
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 |
|---|---|---|
| External radiotherapyThe radiation technique used for each patient will be based on local clinical practices and on number of vertebae to treat between 1*8 Gy; 5*4 Gy and 10*3 Gy | Radiation | Arm B |
| Percutaneous vertebroplastyAlso: Vertebroplasty | Procedure or surgery | Arm A |
Primary outcome
Health economics evaluation
Time frame: 6 months after the end ot treatment
To perform a cost-utility analysis in order to provide recommendations to French decision-makers on the treatment of patients with painful spine metastases. Incremental cost-effectiveness ratio expressed in cost per quality adjusted life year (QALY) gained
1 secondary outcome
Budget impact analysis of vertebroplasty
Time frame: 6 months after the end of treatment
Results and safety
The study was stopped early (reason given: recruitment issues due to feasability issues in centers). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
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Efficacy of Dose Intensified Radiotherapy of Spinal Metastases by Hypofractionated Radiation and IGRT hfSRT Mediated Boost
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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.
Bertrand BR RICHIOUD, MD principal investigator
Center Leon Berard
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External radiotherapy and Percutaneous vertebroplasty in people with Spine Metastases, run by Centre Leon Berard at 7 sites in France.
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 10 inclusion and 13 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: stopped early, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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.
Are results available for this study?
The study was stopped early (reason given: recruitment issues due to feasability issues in centers). Results are not available in the source record.
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?
Health economics evaluation (time frame: 6 months after the end ot treatment). 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 10 Jan 2017.