Extracranial Stereotactic Radiosurgery in Treating Patients With Solid Tumors

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

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.

Study Overview

• Status: Completed
• Conditions: Unspecified Adult Solid Tumor, Protocol Specific
• Intervention / Treatment: Procedure: Radiosurgery

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
• Enrollment (Anticipated): 48
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum tolerated dose for up to 90 days after completion of study treatment	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	day 1 through 90

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: James Urbanic, MD, Wake Forest University Health Sciences

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2002
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: April 5, 2006
• First Submitted That Met QC Criteria: April 5, 2006
• First Posted (Estimate): April 6, 2006

Study Record Updates

• Last Update Posted (Actual): March 14, 2017
• Last Update Submitted That Met QC Criteria: March 13, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: unspecified adult solid tumor, protocol specific
• Other Study ID Numbers: CDR0000466064; CCCWFU-99502; CCCWFU-BG02-187