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Stereotactic Radiosurgery in Treating Patients With Liver Metastases, Lung Metastases, or Other Advanced Solid Tumors

Fractionated Stereotactic Body Radiosurgery for Extracranial Tumors

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00006456
Enrollment
26
Registered
2003-01-27
Start date
1999-02-28
Completion date
2004-11-30
Last updated
2010-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific, lung metastases, liver metastases

Brief summary

RATIONALE: Stereotactic radiosurgery delivers x-rays directly to the tumor and may cause less damage to normal tissue. PURPOSE: Phase II trial to study the effectiveness of stereotactic radiosurgery in treating patients who have liver metastases, lung metastases, or other advanced solid tumors.

Detailed description

OBJECTIVES: * Determine the feasibility of fractionated stereotactic body radiosurgery in patients with advanced extracranial tumors. * Assess the toxicities of this treatment regimen in these patients. * Determine tumor response and cause of death in these patients treated with this regimen. OUTLINE: Patients receive fractionated stereotactic body radiosurgery over 30 minutes for 5-10 days for a total of 3 treatments. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 10-25 patients will be accrued within 2-3 years.

Interventions

RADIATIONstereotactic radiosurgery

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed malignancy * Extracranial recurrent or metastatic disease or primary tumor not predicted to be controlled with standard radiotherapy * Incurable with any standard therapy * No tumors involving critical structures (e.g., mucosal surfaces (bowel or bladder) or heart) * Tumor visible by CT scan PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin less than 2.0 times upper limit of normal (ULN) * AST and ALT less than 5 times ULN Renal: * Creatinine less than 2.0 mg/dL Pulmonary: * FEV1 greater than 0.75 L Other: * No unsuitable size or geometric proportion that would preclude stereotactic immobilization * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 14 days since prior anticancer biologic therapy and recovered Chemotherapy: * At least 14 days since prior anticancer chemotherapy and recovered Endocrine therapy: * At least 14 days since prior anticancer endocrine therapy and recovered Radiotherapy: * See Disease Characteristics * At least 14 days since prior anticancer radiotherapy and recovered Surgery: * Not specified

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026