Clinical trial NCT00311597: Extracranial Stereotactic Radiosurgery in Treating Patients With Solid Tumors
Official title: A Phase I/II Dose-Escalation/Efficacy Study of Palliative Extracranial Radiosurgery Using the Elektra Stereotactic Body Frame System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-04-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: Maximum tolerated dose for up to 90 days after completion of study treatment
timeFrame: day 1 through 90
measure: Minimum dose required for local control as assessed by RECIST one-dimensional criterion and volumetric analysis for 90 days after completion of study treatment
timeFrame: day 1 through 90
Secondary outcomes:
measure: Median time to progression of treated tumor for up to 2 years
timeFrame: day 1 to 2 years
measure: Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0 for up to 90 days after completion of study treatment
timeFrame: day 1 through 90
measure: Cause of death as assessed by medical records and autopsy at time of death
timeFrame: variable, survival of the patient
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: James Urbanic, MD
role: STUDY_CHAIR
References:
citation: 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.