MetastasesNCT00802659

A Phase I/II Dose Escalation Study Using Extracranial Stereotactic Radiosurgery to Control Pain

A study testing Stereotactic radiotherapy in people with Metastases, run by Washington University School of Medicine 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

This study will evaluate pain control and quality of life in patients with paraspinal metastases, who have receive previous radiation therapy to these lesions, using single dose stereotactic radiotherapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Metastases
What is being tested?: Stereotactic radiotherapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: Mar 2008to Dec 2008
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

Age ≥ 18
Prior non-hematogenous, histologically proven malignancy (specific exclusions are multiple myeloma and lymphoma)
Pain attributable to one or two radiographically apparent metastatic lesion(s) amenable to ESRT
Have had prior radiation to area of spine felt to be cause of patient's pain
Zubrod performance status of 0-3
Life expectancy of ≥ 3 months
Signed informed consent prior to registration to study
Radiographic evidence of stable disease outside of the spinal column for at least 6 weeks prior to study entry, as evaluated by pre-study imaging.

Who cannot join

Women who are pregnant or nursing
Either 'no evidence of other active cancerous disease' or 'other sites of known disease are locally controlled'
No radiographic evidence of spinal instability (e.g. spinal cord compression requiring immediate surgical intervention)
No initiation of chemotherapy within 15 days of trial entry.
No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemotherapy, biologic, vaccine therapy, or surgery) for at least 15 days following stereotactic radiosurgery.
No active systemic infection.
No evidence of myelopathy or cauda equina syndrome on clinical evaluation

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase I/II Dose Escalation Study to Evaluate Pain Response Using Extracranial Stereotactic Radiosurgery to Treat Paraspinal Metastasis in Patients Who Have Received Prior Spinal Irradiation

Read the detailed description

The goal of the study is to determine the lowest dose of radiation that can be given to effectively control the tumor and provide effective pain relief.

Conditions: Metastases
Being tested: Stereotactic radiotherapy
Medical subject headings: Neoplasm Metastasis

What participants receive

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

Stereotactic radiotherapyRadiation
Also called Stereotactic Radiosurgery, Paraspinal Metastasis, Prior Spinal Irradiation
This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment patient's pain, and how many side effects participants before you have experienced.

Study groups in NCT00802659
Study group	Role	What they receive
Group -1	Experimental	1000 cGY radiation Receives: Radiation: Stereotactic radiotherapy
Group 1	Experimental	1200 cGY radiation Receives: Radiation: Stereotactic radiotherapy
Group 2	Experimental	1400 cGY radiation Receives: Radiation: Stereotactic radiotherapy
Group 3	Experimental	1600 cGY radiation Receives: Radiation: Stereotactic radiotherapy

What is being measured

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

Optimal Dose of Stereotactic Spinal Irradiation Needed to Obtain Durable Pain Control at 4 Weeks in a Previously Irradiated Spine Field
Optimal dose
1. the maximum tolerated dose (MTD) that will result in a 10% ESRT-induced neurological complications
2. the minimal dose level that can achieve an 80% or more pain control rate, whichever occurs first
Measured: 4 weeks

Secondary outcomes (4)

Duration of Pain Control for Each Dose Level.
A reduction in pain, referable to the site of the spine lesion, by >=30% according to the Brief Pain Inventory (BPI), or a smaller decrease in pain accompanied by a reduction of pain medications.
Measured: 4 years
Determine the Rate of Radiation-induced Myelopathy From Stereotactic Re-irradiation of the Spinal Metastases.
Measured: 4 weeks
Determine the Pattern of Failure After Stereotactic Irradiation of Spinal Metastases.
Measured: 4 years
Quality of Life
As measured by the Functional Assessment of Cancer Therapy - Central Nervous System (FACT-CNS)
Participant can chose on a scale of 0-4 with 0=not at all and 4=very much.
Measured: 4 years

Timeline

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

Mar 2008Dec 2008

First posted5 Dec 2008 (estimated)
Study startMar 2008
Primary completionJun 2008
Study completionDec 2008

Why it stopped: Terminated due to low accrual

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 MetastasesStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00802659
Sponsor's protocol ID: 07-1149
Status last verified: Nov 2014
First submitted: 4 Dec 2008
Last updated: 5 Dec 2014
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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All Metastases trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Dose Escalation Study to Evaluate Pain Response Using Extracranial Stereotactic Radiosurgery to Treat Paraspinal Metastasis in Patients Who Have Received Prior Spinal Irradiation
ClinicalTrials.gov ID: NCT00802659
Acronym / sponsor ID: 07-1149
Conditions: Metastases
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated due to low accrual
Enrolment: 2 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: Mar 2008
Primary completion: Jun 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 5 Dec 2008 (estimated)
Results: Posted 18 Nov 2014

Clinical summary

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

Detailed description

The goal of the study is to determine the lowest dose of radiation that can be given to effectively control the tumor and provide effective pain relief.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group -1	Experimental	Radiation: Stereotactic radiotherapy1000 cGY radiation
Group 1	Experimental	Radiation: Stereotactic radiotherapy1200 cGY radiation
Group 2	Experimental	Radiation: Stereotactic radiotherapy1400 cGY radiation
Group 3	Experimental	Radiation: Stereotactic radiotherapy1600 cGY radiation

Who may qualify

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

Key inclusion criteria (8 listed)

Age ≥ 18
Prior non-hematogenous, histologically proven malignancy (specific exclusions are multiple myeloma and lymphoma)
Pain attributable to one or two radiographically apparent metastatic lesion(s) amenable to ESRT
Have had prior radiation to area of spine felt to be cause of patient's pain
Zubrod performance status of 0-3

Key exclusion criteria (7 listed)

Women who are pregnant or nursing
Either 'no evidence of other active cancerous disease' or 'other sites of known disease are locally controlled'
No radiographic evidence of spinal instability (e.g. spinal cord compression requiring immediate surgical intervention)
No initiation of chemotherapy within 15 days of trial entry.
No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemotherapy, biologic, vaccine therapy, or surgery) for at least 15 days following stereotactic radiosurgery.

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
Stereotactic radiotherapyAlso: Stereotactic Radiosurgery, Paraspinal Metastasis, Prior Spinal IrradiationThis study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment patient's pain, and how many side effects participants before you have experienced.	Radiation	Group -1, Group 1, Group 2, Group 3

Primary outcome

Optimal Dose of Stereotactic Spinal Irradiation Needed to Obtain Durable Pain Control at 4 Weeks in a Previously Irradiated Spine Field
Time frame: 4 weeks
Optimal dose 1. the maximum tolerated dose (MTD) that will result in a 10% ESRT-induced neurological complications 2. the minimal dose level that can achieve an 80% or more pain control rate, whichever occurs first

4 secondary outcomes

Duration of Pain Control for Each Dose Level.
Time frame: 4 years
Determine the Rate of Radiation-induced Myelopathy From Stereotactic Re-irradiation of the Spinal Metastases.
Time frame: 4 weeks
Determine the Pattern of Failure After Stereotactic Irradiation of Spinal Metastases.
Time frame: 4 years
Quality of Life
Time frame: 4 years

Results and safety

Results posted to the registry on 18 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group -1	0	0
Group 1	2	1
Group 2	0	0
Group 3	0	0

Primary outcome: Optimal Dose of Stereotactic Spinal Irradiation Needed to Obtain Durable Pain Control at 4 Weeks in a Previously Irradiated Spine Field

Time frame: 4 weeks

Population analysed: Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.

4 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
Group -1	0 of 0	0 of 0	Not reported
Group 1	1 of 1 (100%)	1 of 1 (100%)	Not reported
Group 2	0 of 0	0 of 0	Not reported
Group 3	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): The study was closed early due to slow accrual.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
(AlvinJ. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.

Related trials for Metastases

RecruitingPhase 2
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Not yet recruitingObservational study
Cost-utility Evaluation of Cytoreductive Surgery With or Without Mitomycin-C Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Resectable Colorectal Peritoneal Metastases
Hyperthermic Intraperitoneal Chemotherap, Colorectal Cancer Metastatic
Active, not recruitingPhase 2
Efficacy of Dose Intensified Radiotherapy of Spinal Metastases by Hypofractionated Radiation and IGRT hfSRT Mediated Boost
Spinal Metastases
RecruitingPhase 2
REGULUS: MRI-guided Adaptive SABR for Liver Cancers
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Not yet recruitingPhase 2
The METAMAX Study: MT027 Allogeneic CAR-T for Brain Metastases From Advanced Solid Tumors
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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.

Jeffrey Bradley, M.D. principal investigator

Washington University School of Medicine

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

Questions about this trial

What is this clinical trial studying?

A study testing Stereotactic radiotherapy in people with Metastases, run by Washington University School of Medicine 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 8 inclusion and 7 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 5 Dec 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2014). 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?

Optimal Dose of Stereotactic Spinal Irradiation Needed to Obtain Durable Pain Control at 4 Weeks in a Previously Irradiated Spine Field (time frame: 4 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 NCT00802659.

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 5 Dec 2014; AzTrials last refreshed its copy on 29 Oct 2026.