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

Metastases Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00802659
• Other study ID #: 07-1149
• Status: Terminated
• Phase: N/A
• First received: December 4, 2008
• Last updated: November 18, 2014
• Start date: March 2008
• Est. completion date: December 2008

Study information

• Verified date: November 2014
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastases
• Neoplasm Metastasis

Intervention

Radiation:
• Stereotactic radiotherapy
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.

Locations

Country	Name	City	State
United States	Washington University	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimal Dose of Stereotactic Spinal Irradiation Needed to Obtain Durable Pain Control at 4 Weeks in a Previously Irradiated Spine Field	Optimal dose; the maximum tolerated dose (MTD) that will result in a 10% ESRT-induced neurological complications; the minimal dose level that can achieve an 80% or more pain control rate, whichever occurs first	4 weeks	Yes
Secondary	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.	4 years	No
Secondary	Determine the Rate of Radiation-induced Myelopathy From Stereotactic Re-irradiation of the Spinal Metastases.		4 weeks	No
Secondary	Determine the Pattern of Failure After Stereotactic Irradiation of Spinal Metastases.		4 years	No
Secondary	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.	4 years	No

External Links

•   (AlvinJ. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine