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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


N/A
18 Years
N/A
Not Enrolling
Both
Metastases

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the optimal dose of stereotactic spinal irradiation needed to obtain durable pain control at 4 weeks in a previously irradiated spine field.

Outcome Time Frame:

4 weeks

Safety Issue:

Yes

Principal Investigator

Jeffrey Bradley, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

07-1149

NCT ID:

NCT00802659

Start Date:

March 2008

Completion Date:

December 2008

Related Keywords:

  • Metastases
  • Neoplasm Metastasis

Name

Location

Washington UniversitySt. Louis, Missouri  63110