Metastatic CancersNCT02376933

Vertebral Augmentation and Radiotherapy of Collapse Spinal Metastatic Cancer

A study testing Vertebroplasty and Radiotherapy in people with Metastatic Cancers and Multiple Myeloma, run by University of Arizona at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Vertebral augmentation with radiotherapy to increase the functional status and quality of life for patients with vertebral body metastatic cancers. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Metastatic Cancers, Multiple Myeloma, Vertebral Fracture
What is being tested?: Vertebroplasty and Radiotherapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: 20 Aug 2013to 7 Apr 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Diagnosis of metastatic disease to the vertebra or multiple myeloma
Negative pregnancy test within 2 weeks prior to registration
Life expectancy of >= 3 months and Karnofsky performance status (KPS) score >= 40
Pain scale score >=5
Pain at involved vertebral body not adequately controlled
Osteolysis of vertebral bodies

Show all 10Show fewer

Must agree to practice adequate means of birth control
Must sign informed consent prior to study entry
Must be able to understand the English language
Absence of any serious cognitive or psychiatric problems potentially hampering compliance with the study and follow-up schedule.

Who cannot join

Spinal Cord Compression

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Arizona
Tucson, Arizona, 85724

Other trials in United States

About this study

Official title: Phase 2 Study of Vertebral Augmentation and Radiotherapy in Painful or at Risk of Collapse Spinal Metastatic Cancer/Multiple Myeloma

Vertebral augmentation with radiotherapy to increase the functional status and quality of life for patients with vertebral body metastatic cancers.

Read the detailed description

The study quantifies the reduction of pain and changes in quality of life associated with vertebral augmentation. This study is conducted in patients with metastatic cancer or multiple myeloma involving the spine. This study addresses the value of vertebral augmentation in combination with radiotherapy in the setting of cancer to the spine. The patient's pain, overall quality of life, and fracture development/avoidance will be compared to patients treated only with radiotherapy in the past.

Conditions: Metastatic Cancers, Multiple Myeloma, Vertebral Fracture
Being tested: Vertebroplasty, Radiotherapy
Keywords: vertebral bodies, vertebral fracture, vertebral augmentation, radiotherapy, vertebroplasty, kyphoplasty
Medical subject headings: Neoplasms, Multiple Myeloma, Spinal Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VertebroplastyProcedure or surgery
Also called kyphoplasty
Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement.
RadiotherapyRadiation
Radiotherapy of metastatic lesions to the spine.

Study groups in NCT02376933
Study group	Role	What they receive
Vertebroplasty with Radiotherapy	Experimental	Vertebroplasty with Radiotherapy is given in either order. Radiotherapy dosage is at the discretion of the treating physician. Vertebroplasty is applied to fractured vertebrae. Receives: Procedure: Vertebroplasty; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Assessment From the Worst Pain Score on Brief Pain Inventory as Compared to Historical Radiation Therapy Oncology Group (RTOG) 9714 Study.
Assessment of the patient's pain, activities and quality of life will be gathered from the patient in returning for follow-up or by contacting the patient by phone approximately 1 week following the completion of their first procedure, whether it be the vertebral augmentation or the radiotherapy (5 - 10 days following). Mandatory assessments include:
- Worst Pain Score - Brief Pain Inventory (BPI) - The Worst Pain Assessment on the Brief Inventory Scale is an assessment tool of current pain intensity and pain intensity within the last 24 hours when not on pain control medications. 0 being no pain and 10 is the worst pain possible. See protocol attachments
Measured: 14 weeks

Secondary outcomes (3)

Activity Level Assessment From the Roland Morris Questionnaire (RDQ) and Karnofsky Performance Status (KPS)
Roland-Morris Disability Questionnaire - The score of the RDQ is the total number of items checked - i.e. from a minimum of 0 (best) to a maximum of 24 (worst).
Karnofsky Performance Status (KPS) - scale from 10 (moribund, fatal processes progressing rapidly) to 100 (normal, no complaints, no evidence of disease).
Measured: 14 weeks
Quality of Life Assessment From the EORTC QLQ C30 Questionnaire.
EORTC QLQ-C30 (version 3) - The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.
Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Thus a high score for a functional scale represents a high / healthy level of functioning,a high score for the global health status / QoL represents a high QoL,but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: 14 weeks
Fracture Rates Detected From X-rays.
Measured: 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Aug 20137 Apr 2017

First posted3 Mar 2015 (estimated)
Study start20 Aug 2013
Primary completion10 Aug 2016
Study completion7 Apr 2017

Why it stopped: PI left the department; protocol transfer did not take place.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Metastatic CancersStudies of the same condition, open and under way.
More trials run by University of ArizonaThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02376933
Sponsor's protocol ID: 1300000562
Status last verified: Nov 2018
First submitted: 20 Feb 2015
Last updated: 7 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Study of Vertebral Augmentation and Radiotherapy in Painful or at Risk of Collapse Spinal Metastatic Cancer/Multiple Myeloma
ClinicalTrials.gov ID: NCT02376933
Acronym / sponsor ID: 1300000562
Conditions: Metastatic Cancers, Multiple Myeloma, Vertebral Fracture
Keywords: vertebral bodies, vertebral fracture, vertebral augmentation, radiotherapy, vertebroplasty, kyphoplasty
Study type: Interventional
Recruitment status: TerminatedReason stopped: PI left the department; protocol transfer did not take place.
Enrolment: 11 participants (actual)
Lead sponsor: University of ArizonaUniversity, hospital or other
Study start: 20 Aug 2013 (actual)
Primary completion: 10 Aug 2016 (actual)
Study completion: 7 Apr 2017 (actual)
First posted: 3 Mar 2015 (estimated)
Results: Posted 7 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Vertebral augmentation with radiotherapy to increase the functional status and quality of life for patients with vertebral body metastatic cancers.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Vertebroplasty with Radiotherapy	Experimental	Procedure: Vertebroplasty, Radiation: RadiotherapyVertebroplasty with Radiotherapy is given in either order. Radiotherapy dosage is at the discretion of the treating physician. Vertebroplasty is applied to fractured vertebrae.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Diagnosis of metastatic disease to the vertebra or multiple myeloma
Negative pregnancy test within 2 weeks prior to registration
Life expectancy of >= 3 months and Karnofsky performance status (KPS) score >= 40
Pain scale score >=5
Pain at involved vertebral body not adequately controlled

Key exclusion criteria (1 listed)

Spinal Cord Compression

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
VertebroplastyAlso: kyphoplastyUnder imaging guidance, a fractured vertebral body is stabilized with injected bone cement.	Procedure or surgery	Vertebroplasty with Radiotherapy
RadiotherapyRadiotherapy of metastatic lesions to the spine.	Radiation	Vertebroplasty with Radiotherapy

Primary outcome

Pain Assessment From the Worst Pain Score on Brief Pain Inventory as Compared to Historical Radiation Therapy Oncology Group (RTOG) 9714 Study.
Time frame: 14 weeks
Assessment of the patient's pain, activities and quality of life will be gathered from the patient in returning for follow-up or by contacting the patient by phone approximately 1 week following the completion of their first procedure, whether it be the vertebral augmentation or the radiotherapy (5 - 10 days following). Mandatory assessments include: - Worst Pain Score - Brief Pain Inventory (BPI) - The Worst Pain Assessment on the Brief Inventory Scale is an assessment tool of current pain intensity and pain intensity within the last 24 hours when not on pain control medications. 0 being no pain and 10 is the worst pain possible. See protocol attachments

3 secondary outcomes

Activity Level Assessment From the Roland Morris Questionnaire (RDQ) and Karnofsky Performance Status (KPS)
Time frame: 14 weeks
Quality of Life Assessment From the EORTC QLQ C30 Questionnaire.
Time frame: 14 weeks
Fracture Rates Detected From X-rays.
Time frame: 14 weeks

Results and safety

Results posted to the registry on 7 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vertebroplasty With Radiotherapy	10	8

Primary outcome: Pain Assessment From the Worst Pain Score on Brief Pain Inventory as Compared to Historical Radiation Therapy Oncology Group (RTOG) 9714 Study.

Time frame: 14 weeks

Population analysed: Study terminated when PI left institution; data not collected.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vertebroplasty With Radiotherapy	2 of 10 (20%)	5 of 10 (50%)	1 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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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.

Krisha Howell, MD principal investigator

University of Arizona Radiation Oncology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vertebroplasty and Radiotherapy in people with Metastatic Cancers and Multiple Myeloma, run by University of Arizona 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 10 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 7 Nov 2018. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pain Assessment From the Worst Pain Score on Brief Pain Inventory as Compared to Historical Radiation Therapy Oncology Group (RTOG) 9714 Study. (time frame: 14 weeks). 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 NCT02376933.

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 7 Nov 2018.