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Clinical Trials/NCT00311597
NCT00311597CompletedPhase 1

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

Wake Forest University Health Sciences2 sites in 1 country48 target enrollmentStarted: June 2002Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
48
Locations
2
Primary Endpoint
Maximum tolerated dose for up to 90 days after completion of study treatment
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 120 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Maximum tolerated dose for up to 90 days after completion of study treatment

Time Frame: 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

Time Frame: day 1 through 90

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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