Extracranial Stereotactic Radiosurgery in Treating Patients With Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00311597
First received: April 5, 2006
Last updated: July 10, 2013
Last verified: July 2013
  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: 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

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Maximum tolerated dose for up to 90 days after completion of study treatment [ Time Frame: day 1 through 90 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median time to progression of treated tumor for up to 2 years [ Time Frame: day 1 to 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Cause of death as assessed by medical records and autopsy at time of death [ Time Frame: variable, survival of the patient ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: June 2002
Estimated Study Completion Date: December 2016
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 and older
Genders Eligible for Study:   Both
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
Comprehensive Cancer Center of Wake Forest University
Investigators
Study Chair: James Urbanic, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional 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: Comprehensive Cancer Center of Wake Forest University
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: July 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 18, 2014