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CompletedNCT00311597Updated Mar 14, 2017

Extracranial Stereotactic Radiosurgery in Treating Patients With Solid Tumors

A Phase 1/2 interventional study of Radiosurgery in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2017-03-14.

Sponsored by Wake Forest University Health Sciences · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 10 months after the study started (first participant enrolled Jun 2002, registered Apr 2006).
Phase
Phase 1/2
Study type
Interventional
Enrollment
48
Allocation
Non-randomized
Ages
18 Years to 120 Years
Sex
All
01

Study 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.

Read the 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.

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.

02

Conditions studied

  • Unspecified Adult Solid Tumor, Protocol Specific

Keywords

  • unspecified adult solid tumor, protocol specific
03

In context

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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)
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    Single fractionated radiation adjusted for tumor size

    Single fractionated radiation adjusted for volume of tumor tissue encompassed by desired isodose line

    Procedure: Radiosurgery

Interventions

  • ProcedureRadiosurgery

    single fractionated radiation therapy

06

What researchers measure

Primary outcomes

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

    Time frame: day 1 through 90

  2. 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

  1. Median time to progression of treated tumor for up to 2 years

    Time frame: day 1 to 2 years

  2. Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0 for up to 90 days after completion of study treatment

    Time frame: day 1 through 90

  3. Cause of death as assessed by medical records and autopsy at time of death

    Time frame: variable, survival of the patient

07

Study locations

1 site
  • Wake Forest University Comprehensive Cancer Center
    Winston-Salem, North Carolina 27157-1096, United States
08

References and documents

Publications

  • Stieber VW, Hinson W, Kearns W, et al.: A phase I/II dose-escalation/efficacy study of palliative stereotactic body radiosurgery, including bioanatomic imaging to assess response. [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-2381, S563-4, 2004.
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00311597
Lead sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Apr 6, 2006
Start date
Jun 2002
Primary completion
Sep 2007
Completion
Mar 2009
Last update
Mar 14, 2017

Study contacts

James Urbanic, MD
study chair · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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