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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose for up to 90 days after completion of study treatment

Outcome Time Frame:

day 1 through 90

Safety Issue:

Yes

Principal Investigator

James Urbanic, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CDR0000466064

NCT ID:

NCT00311597

Start Date:

June 2002

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096