Extracranial Stereotactic Radiosurgery in Treating Patients With Solid Tumors

Study Overview
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Brief Summary
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RATIONALE: Extracranial stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I/II trial is studying the side effects and best dose of extracranial stereotactic radiosurgery and to see how well it works in treating patients with solid tumors.

Detailed Description
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OBJECTIVES: Primary Establish the maximum tolerated dose (MTD) of extracranial stereotactic radiosurgery in patients with isolated tumors. (Phase I) Determine the minimum dose required for local control. (Phase II) Secondary Determine the radiographic response rate. Determine the median time to progression of the treated tumor. Evaluate the toxicity of treatment. Evaluate the cause of death. OUTLINE: This is a phase I dose-escalation study followed by a phase II open-label study. Patients are stratified according to tumor size. Phase I: Patients undergo stereotactic radiosurgery to one lesion. Cohorts of 3-6 patients undergo escalating doses of stereotactic radiosurgery until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 33% of patients experience dose-limiting toxicity within 3 months of treatment. Phase II: Patients undergo stereotactic radiosurgery to one lesion at the MTD or at the dose at which local control at 3 months is ≥ 80%, as determined in phase I. After completion of study treatment, patients are followed at 1 month, 3 months, and then every 3 months thereafter. PROJECTED ACCRUAL: At least 48 patients will be accrued for this study.

Official Title
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A Phase I/II Dose-Escalation/Efficacy Study of Palliative Extracranial Radiosurgery Using the Elektra Stereotactic Body Frame System

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Procedure: Radiosurgery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Presence of well-circumscribed tumor on contrast-enhanced CT scan or MRI Maximum diameter of 6 cm PATIENT CHARACTERISTICS: Life expectancy ≥ 3 months Not pregnant Fertile patients must use effective contraception Negative pregnancy test Must be able to tolerate CT scan or MRI contrast PRIOR CONCURRENT THERAPY: At least 3 weeks since prior chemotherapy or immunotherapy No prior treatment on this study No chemotherapy or immunotherapy during and for 4 weeks after completion of study treatment No concurrent external-beam radiotherapy overlapping with the radiosurgically-treated volume (including low-dose regions)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single fractionated radiation adjusted for tumor size<br>Single fractionated radiation adjusted for volume of tumor tissue encompassed by desired isodose line | Procedure: Radiosurgery<br>* single fractionated radiation therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose for up to 90 days after completion of study treatment |  | day 1 through 90 | 
| Minimum dose required for local control as assessed by RECIST one-dimensional criterion and volumetric analysis for 90 days after completion of study treatment |  | day 1 through 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median time to progression of treated tumor for up to 2 years |  | day 1 to 2 years | 
| Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0 for up to 90 days after completion of study treatment |  | day 1 through 90 | 
| Cause of death as assessed by medical records and autopsy at time of death |  | variable, survival of the patient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific