Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Pain

Neoplastic Processes

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.

Stereotactic radiotherapy

Jeffrey Bradley, M.D.

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.

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.

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

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

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

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.

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.

Washington University School of Medicine

1000 cGY 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 of patient's pain, and how many side effects participants before have experienced.

Group -1

1200 cGY 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 of patient's pain, and how many side effects participants before have experienced.

Group 1

1400 cGY 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 of patient's pain, and how many side effects participants before have experienced.

Group 2

1600 cGY 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 of patient's pain, and how many side effects participants before have experienced.

Group 3

Total

<=18 years

Between 18 and 65 years

>=65 years

Age, Categorical

Female

Male

Gender

United States

Region of Enrollment

The study was closed early due to slow accrual.

Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.

Spots Global Cancer Trial Database for A Phase I/II Dose Escalation Study Using Extracranial Stereotactic Radiosurgery to Control Pain

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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