Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
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.
Interventions
PROCEDURERadiosurgery
single fractionated radiation therapy
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| 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
| 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 |
Countries
United States
Outcome results
None listed