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Extracranial Stereotactic Radiosurgery in Treating Patients With Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT00311597
First received: April 5, 2006
Last updated: March 13, 2017
Last verified: March 2017
  Purpose

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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific Procedure: Radiosurgery Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Median time to progression of treated tumor for up to 2 years [ Time Frame: 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 [ Time Frame: day 1 through 90 ]
  • Cause of death as assessed by medical records and autopsy at time of death [ Time Frame: variable, survival of the patient ]

Estimated Enrollment: 48
Actual Study Start Date: June 2002
Study Completion Date: March 2009
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: April 5, 2006
Last Updated: March 13, 2017

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

ClinicalTrials.gov processed this record on August 22, 2017