Extracranial Stereotactic Radiosurgery in Treating Patients With Solid Tumors

Wake Forest University (WFU)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Treatments

Procedure: Radiosurgery

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00311597

CDR0000466064

CCCWFU-99502

CCCWFU-BG02-187

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 estimated patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)