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

Not Applicable

Terminated

• Conditions: Metastases
• Interventions: Radiation: Stereotactic radiotherapy

• Registration Number: NCT00802659
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2008-06
• Study Completion: 2008-12
• Study First Submitted: 2008-12-04
• Study First Submitted QC: 2008-12-04
• Study First Posted: 2008-12-05
• Status Verified: 2014-11
• Results First Submitted: 2014-11-10
• Results First Submitted QC: 2014-11-10
• Results First Posted: 2014-11-18
• Last Update Submitted: 2014-11-18
• Last Update Posted: 2014-12-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Stereotactic radiotherapy	1400 cGY radiation
Group 3	Stereotactic radiotherapy	1600 cGY radiation
Group 1	Stereotactic radiotherapy	1200 cGY radiation
Group -1	Stereotactic radiotherapy	1000 cGY radiation

Primary Outcome Measures

Name	Time	Method
Optimal Dose of Stereotactic Spinal Irradiation Needed to Obtain Durable Pain Control at 4 Weeks in a Previously Irradiated Spine Field	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Washington University; 🇺🇸 St. Louis, Missouri, United States