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Extracranial Stereotactic Radiosurgery in Treating Patients With Solid Tumors

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ClinicalTrials.gov Identifier: NCT00311597
Recruitment Status : Completed
First Posted : April 6, 2006
Last Update Posted : March 14, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.


Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Procedure: Radiosurgery Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Dose-Escalation/Efficacy Study of Palliative Extracranial Radiosurgery Using the Elektra Stereotactic Body Frame System
Actual Study Start Date : June 2002
Primary Completion Date : September 2007
Study Completion Date : March 2009

Arm Intervention/treatment
Experimental: Single fractionated radiation adjusted for tumor size
Single fractionated radiation adjusted for volume of tumor tissue encompassed by desired isodose line
Procedure: Radiosurgery
single fractionated radiation therapy



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311597


Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Study Chair: James Urbanic, MD Wake Forest University Health Sciences

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.

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00311597     History of Changes
Other Study ID Numbers: CDR0000466064
CCCWFU-99502
CCCWFU-BG02-187
First Posted: April 6, 2006    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017

Keywords provided by Wake Forest University Health Sciences:
unspecified adult solid tumor, protocol specific