Clinical trial NCT00802659: A Phase I/II Dose Escalation Study Using Extracranial Stereotactic Radiosurgery to Control Pain
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Metastases
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2008-12-05
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Optimal Dose of Stereotactic Spinal Irradiation Needed to Obtain Durable Pain Control at 4 Weeks in a Previously Irradiated Spine Field
timeFrame: 4 weeks
Secondary outcomes:
measure: Duration of Pain Control for Each Dose Level.
timeFrame: 4 years
measure: Determine the Rate of Radiation-induced Myelopathy From Stereotactic Re-irradiation of the Spinal Metastases.
timeFrame: 4 weeks
measure: Determine the Pattern of Failure After Stereotactic Irradiation of Spinal Metastases.
timeFrame: 4 years
measure: Quality of Life
timeFrame: 4 years
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jeffrey Bradley, M.D.
role: PRINCIPAL_INVESTIGATOR
References: