Osseous Spine MetastasesPhase 3NCT00267033
Evaluation of Vertebroplasty Associated With Radiotherapy for Spine Metastases (EVAR)
A Phase 3 study testing injection of orthopaedic cement into vertebral bodies in people with Osseous Spine Metastases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
A randomized phase III study of palliative external beam radiotherapy (RTOG 97-14) has shown that 8 Gy in a single fraction is very effective in providing pain relief, with complete or partial improvement in pain seen in 66% of patients with bone metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osseous Spine Metastases
- What is being tested?
- injection of orthopaedic cement into vertebral bodies
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2005to Aug 2008
- Phase
- Phase 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
- Osseous spine metastases from squamous cell carcinoma or adenocarcinoma
- One to four painful metastases located between the second cervical vertebra and the fifth lumbar vertebra
- Moderate to severe pain
- No spinal cord compression
- Karnofsky performance status > 40
Who cannot join
- Previous radiotherapy or surgery
- Vertebral fracture or any other formal indication of stabilization of the rachis by surgery or vertebroplasty
- Spinal cord compression
- Known anomaly of the haemostasis, or needed anticoagulant treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of Vertebroplasty and Radiotherapy Versus Radiotherapy Alone for Osseous Spine Metastases
A randomized phase III study of palliative external beam radiotherapy (RTOG 97-14) has shown that 8 Gy in a single fraction is very effective in providing pain relief, with complete or partial improvement in pain seen in 66% of patients with bone metastases. Percutaneous vertebroplasty (PV) is a technique designed to consolidate pathologic vertebral bodies through the injection of orthopaedic cement under fluoroscopic guidance. Consolidation provides rapid pain relief to painful vertebral body lesions secondary to osteoporosis, haemangiomas, myeloma and metastatic diseases, with complete or partial improvement in pain seen in 70-85% of patients. To date, no randomized trial has tested the association of vertebroplasty and radiotherapy to enhance pain relief for patients with painful osseous spine metastases.
A randomized trial has been designed to determine whether vertebroplasty and radiotherapy (8 Gy in a single fraction) provide enhancement pain and narcotic relief compared to radiotherapy alone for patients with painful osseous spine metastases
Read the detailed description
Patients with 1 to 4 painful osseous spine metastases are randomized to 1 of 2 treatment arms:
- Arm 1: 8 Gy in a single fraction
- Arm 2: 8 Gy in a single fraction followed by vertebroplasty of the vertebral bodies, within 14 days after radiotherapy
- Conditions
- Osseous Spine Metastases
- Being tested
- injection of orthopaedic cement into vertebral bodies
- Keywords
- Neoplasm Metastasis, Bone Neoplasms, Pain, Radiotherapy, Vertebroplasty, Combined modality therapy
- Medical subject headings
- Neoplasm Metastasis, Bone Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of orthopaedic cement into vertebral bodiesProcedure or surgery
injection of orthopaedic cement into vertebral bodies
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | injection of orthopaedic cement into vertebral bodies Receives: Procedure: injection of orthopaedic cement into vertebral bodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pain relief with the Brief Pain Index (BPI), by a blind arm trial algologist, 3 months after radiotherapy.
Measured: 3 months after radiotherapy
Response will be scored as complete (no pain), partial (improvement of < 2 points in BPI), stable (+/- 1 point change in BPI) or progressive (> 2 point worsening of BPI).
Measured: during the study
Complete and partial responses will be considered treatment success, and stable and progressive responses will be considered treatment failures
Measured: during the study
Secondary outcomes (3)
Evaluation of pain relief one month after radiotherapy
Measured: one month after radiotherapy
BPI-SF and EORTC QLQ-C30 will be used to assess general cancer quality of life.
Measured: during the study
The incidence of vertebral pathologic fracture will be registered.
Measured: one 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 posted20 Dec 2005 (estimated)
- Study startNov 2005
- Primary completionFeb 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osseous Spine MetastasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- jean-Marc SIMON, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267033
- Sponsor's protocol ID
- P040426
- Other IDs
- AOM04013
- Status last verified
- Mar 2007
- First submitted
- 19 Dec 2005
- Last updated
- 2 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hartsell WF, Scott CB, Bruner DW, Scarantino CW, Ivker RA, Roach M 3rd, Suh JH, Demas WF, Movsas B, Petersen IA, Konski AA, Cleeland CS, Janjan NA, DeSilvio M. Randomized trial of short- versus long-course radiotherapy for palliation of painful bone metastases. J Natl Cancer Inst. 2005 Jun 1;97(11):798-804. doi: 10.1093/jnci/dji139.
PubMed 15928300Weill A, Chiras J, Simon JM, Rose M, Sola-Martinez T, Enkaoua E. Spinal metastases: indications for and results of percutaneous injection of acrylic surgical cement. Radiology. 1996 Apr;199(1):241-7. doi: 10.1148/radiology.199.1.8633152.
PubMed 8633152
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Vertebroplasty and Radiotherapy Versus Radiotherapy Alone for Osseous Spine Metastases
- ClinicalTrials.gov ID
- NCT00267033
- Acronym / sponsor ID
- P040426
- Conditions
- Osseous Spine Metastases
- Keywords
- Neoplasm Metastasis, Bone Neoplasms, Pain, Radiotherapy, Vertebroplasty, Combined modality therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 20 Dec 2005 (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.
A randomized phase III study of palliative external beam radiotherapy (RTOG 97-14) has shown that 8 Gy in a single fraction is very effective in providing pain relief, with complete or partial improvement in pain seen in 66% of patients with bone metastases. Percutaneous vertebroplasty (PV) is a technique designed to consolidate pathologic vertebral bodies through the injection of orthopaedic cement under fluoroscopic guidance. Consolidation provides rapid pain relief to painful vertebral body lesions secondary to osteoporosis, haemangiomas, myeloma and metastatic diseases, with complete or partial improvement in pain seen in 70-85% of patients. To date, no randomized trial has tested the association of vertebroplasty and radiotherapy to enhance pain relief for patients with painful osseous spine metastases.
A randomized trial has been designed to determine whether vertebroplasty and radiotherapy (8 Gy in a single fraction) provide enhancement pain and narcotic relief compared to radiotherapy alone for patients with painful osseous spine metastases
Detailed description
Patients with 1 to 4 painful osseous spine metastases are randomized to 1 of 2 treatment arms:
- Arm 1: 8 Gy in a single fraction
- Arm 2: 8 Gy in a single fraction followed by vertebroplasty of the vertebral bodies, within 14 days after radiotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: injection of orthopaedic cement into vertebral bodiesinjection of orthopaedic cement into vertebral bodies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Osseous spine metastases from squamous cell carcinoma or adenocarcinoma
- One to four painful metastases located between the second cervical vertebra and the fifth lumbar vertebra
- Moderate to severe pain
- No spinal cord compression
- Karnofsky performance status > 40
Key exclusion criteria (4 listed)
- Previous radiotherapy or surgery
- Vertebral fracture or any other formal indication of stabilization of the rachis by surgery or vertebroplasty
- Spinal cord compression
- Known anomaly of the haemostasis, or needed anticoagulant treatment
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 |
|---|---|---|
| injection of orthopaedic cement into vertebral bodiesinjection of orthopaedic cement into vertebral bodies | Procedure or surgery | 1 |
Primary outcome
Evaluation of pain relief with the Brief Pain Index (BPI), by a blind arm trial algologist, 3 months after radiotherapy.
Time frame: 3 months after radiotherapy
Response will be scored as complete (no pain), partial (improvement of < 2 points in BPI), stable (+/- 1 point change in BPI) or progressive (> 2 point worsening of BPI).
Time frame: during the study
Complete and partial responses will be considered treatment success, and stable and progressive responses will be considered treatment failures
Time frame: during the study
3 secondary outcomes
Evaluation of pain relief one month after radiotherapy
Time frame: one month after radiotherapy
BPI-SF and EORTC QLQ-C30 will be used to assess general cancer quality of life.
Time frame: during the study
The incidence of vertebral pathologic fracture will be registered.
Time frame: one 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 2 Dec 2008.
- Background: PubMed 15928300Hartsell WF, Scott CB, Bruner DW, Scarantino CW, Ivker RA, Roach M 3rd, Suh JH, Demas WF, Movsas B, Petersen IA, Konski AA, Cleeland CS, Janjan NA, DeSilvio M. Randomized trial of short- versus long-course radiotherapy for palliation of painful bone metastases. J Natl Cancer Inst. 2005 Jun 1;97(11):798-804. doi: 10.1093/jnci/dji139.
- Background: PubMed 8633152Weill A, Chiras J, Simon JM, Rose M, Sola-Martinez T, Enkaoua E. Spinal metastases: indications for and results of percutaneous injection of acrylic surgical cement. Radiology. 1996 Apr;199(1):241-7. doi: 10.1148/radiology.199.1.8633152.
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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.
jean-Marc SIMON, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing injection of orthopaedic cement into vertebral bodies in people with Osseous Spine Metastases, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 5 inclusion and 4 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 2 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
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?
Evaluation of pain relief with the Brief Pain Index (BPI), by a blind arm trial algologist, 3 months after radiotherapy. (time frame: 3 months after radiotherapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00267033, which also lists 2 linked publications.
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 2 Dec 2008.