Adult Spinal Cord NeoplasmPhase 1NCT01407341
Beta-Tricalcium Phosphate Bone Graft in Treating Patients Undergoing Surgery For Metastatic Spine Cancer
A Phase 1 study testing musculoskeletal complications management/prevention, bone graft and quality-of-life assessment in people with Adult Spinal Cord Neoplasm and Spinal Bone Metastases, run by University of Southern California at 1 site in United States.
Trial summary
This pilot clinical trial studies beta-tricalcium phosphate bone graft in treating patients undergoing surgery for metastatic spine cancer. A bone graft may help healing and bone growth in patients undergoing surgery for spine cancer Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adult Spinal Cord Neoplasm, Spinal Bone Metastases, Spinal Cord Compression
- What is being tested?
- musculoskeletal complications management/prevention, bone graft and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Aug 2012
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients undergoing surgery for spinal decompression for tatic spine cancer who require bone substitute for a posterolateral spinal fusion
- Patients may or may not have posterolateral instrumentation
Who cannot join
- Status-post previous fusion with allogeneic bone graft
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033-0804
About this study
Official title: ChronOS Stability Study: For Metastatic Cancer
This pilot clinical trial studies beta-tricalcium phosphate bone graft in treating patients undergoing surgery for metastatic spine cancer. A bone graft may help healing and bone growth in patients undergoing surgery for spine cancer
Read the detailed description
OBJECTIVES: I. To determine if Chronos (beta-tricalcium phosphate bone graft) will form a posterolateral fusion mass in patients undergoing fusion surgery for spine cancer within 12 months. II. To evaluate quality of life following the use of ChronOS as measured by (a) pain (or lack of pain) associated with pseudoarthrosis and (b) the need for additional treatment for instability as a result of hardware failure. OUTLINE: Patients undergo placement of beta-tricalcium phosphate bone graft strips posterolaterally during surgery. After completion of study treatment, patients are followed up at 1 month and then every 3 months for 1 year.
- Being tested
- musculoskeletal complications management/prevention, bone graft, quality-of-life assessment, questionnaire administration
- Medical subject headings
- Spinal Cord Neoplasms, Spinal Cord Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musculoskeletal complications management/preventionProcedure or surgery
Also called complications management/prevention, musculoskeletal, management/prevention, musculoskeletal complications
Receive beta tricalcium-phosphate bone graft
bone graftProcedure or surgery
Receive beta tricalcium-phosphate bone graft
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (ChronOS) | Experimental | Patients undergo placement of beta-tricalcium phosphate bone graft strips posterolaterally during surgery. Receives: Procedure: musculoskeletal complications management/prevention; Procedure: bone graft; Procedure: quality-of-life assessment; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of durable posterolateral fusion
Measured from x-ray and/or computed tomography (CT) scans. Standard criteria of determining fusion is visualization of continuous trabeculating bone bridging the transverse processes and facets on AP and lateral x-rays or when there is < 2 degree angular motion and < 2mm of translation on standing flexion and extension radiographs.
Measured: Within 12 months
Secondary outcomes (5)
Achievement of posterolateral fusion
Measured: Up to 12 months
Occurrence of subsequent hardware failure
Measured: Every 3 months for 12 months
Requirement of additional treatment is for instability
Measured: Within 12 months
First documentation of posterolateral fusion
Measured: Within 12 months
Occurrence of pain or disability experienced after surgery that is related to spinal metastasis or is a consequence of the resulting treatment
Measured: Every 3 months for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2012
- Study completionAug 2012
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Spinal Cord NeoplasmStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Thomas Chen, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407341
- Sponsor's protocol ID
- 0S-09-12
- Other IDs
- NCI-2011-01243
- Status last verified
- Aug 2012
- First submitted
- 29 Jul 2011
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ChronOS Stability Study: For Metastatic Cancer
- ClinicalTrials.gov ID
- NCT01407341
- Acronym / sponsor ID
- 0S-09-12
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 2 Aug 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.
This pilot clinical trial studies beta-tricalcium phosphate bone graft in treating patients undergoing surgery for metastatic spine cancer. A bone graft may help healing and bone growth in patients undergoing surgery for spine cancer
Detailed description
OBJECTIVES: I. To determine if Chronos (beta-tricalcium phosphate bone graft) will form a posterolateral fusion mass in patients undergoing fusion surgery for spine cancer within 12 months. II. To evaluate quality of life following the use of ChronOS as measured by (a) pain (or lack of pain) associated with pseudoarthrosis and (b) the need for additional treatment for instability as a result of hardware failure. OUTLINE: Patients undergo placement of beta-tricalcium phosphate bone graft strips posterolaterally during surgery. After completion of study treatment, patients are followed up at 1 month and then every 3 months for 1 year.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (ChronOS) | Experimental | Procedure: musculoskeletal complications management/prevention, Procedure: bone graft, Procedure: quality-of-life assessment, Other: questionnaire administrationPatients undergo placement of beta-tricalcium phosphate bone graft strips posterolaterally during surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All patients undergoing surgery for spinal decompression for tatic spine cancer who require bone substitute for a posterolateral spinal fusion
- Patients may or may not have posterolateral instrumentation
Key exclusion criteria (1 listed)
- Status-post previous fusion with allogeneic bone graft
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 |
|---|---|---|
| musculoskeletal complications management/preventionAlso: complications management/prevention, musculoskeletal, management/prevention, musculoskeletal complicationsReceive beta tricalcium-phosphate bone graft | Procedure or surgery | Supportive care (ChronOS) |
| bone graftReceive beta tricalcium-phosphate bone graft | Procedure or surgery | Supportive care (ChronOS) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Supportive care (ChronOS) |
| questionnaire administrationAncillary studies | Other | Supportive care (ChronOS) |
Primary outcome
Achievement of durable posterolateral fusion
Time frame: Within 12 months
Measured from x-ray and/or computed tomography (CT) scans. Standard criteria of determining fusion is visualization of continuous trabeculating bone bridging the transverse processes and facets on AP and lateral x-rays or when there is < 2 degree angular motion and < 2mm of translation on standing flexion and extension radiographs.
5 secondary outcomes
Achievement of posterolateral fusion
Time frame: Up to 12 months
Occurrence of subsequent hardware failure
Time frame: Every 3 months for 12 months
Requirement of additional treatment is for instability
Time frame: Within 12 months
First documentation of posterolateral fusion
Time frame: Within 12 months
Occurrence of pain or disability experienced after surgery that is related to spinal metastasis or is a consequence of the resulting treatment
Time frame: Every 3 months for 12 months
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2014.
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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.
Thomas Chen principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing musculoskeletal complications management/prevention, bone graft and quality-of-life assessment in people with Adult Spinal Cord Neoplasm and Spinal Bone Metastases, run by University of Southern California at 1 site in United States.
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 2 inclusion and 1 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 6 Feb 2014. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Lack of funding). 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?
Achievement of durable posterolateral fusion (time frame: Within 12 months). 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 6 Feb 2014.