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

The Washington University

Status: Terminated

Conditions: Metastases

Treatments: Radiation: Stereotactic radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00802659

07-1149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 4 patient groups

Group -1

Experimental group

Description:

1000 cGY radiation

Treatment:

Radiation: Stereotactic radiotherapy

Group 1

Experimental group

Description:

1200 cGY radiation

Treatment:

Radiation: Stereotactic radiotherapy

Group 2

Experimental group

Description:

1400 cGY radiation

Treatment:

Radiation: Stereotactic radiotherapy

Group 3

Experimental group

Description:

1600 cGY radiation

Treatment:

Radiation: Stereotactic radiotherapy