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

Virginia Commonwealth University (VCU)

Status and phase: Completed; Phase 2

Conditions: Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Radiation: stereotactic radiosurgery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00006456

MCV-MCC-9812-2C

CDR0000068151

P30CA016059 (U.S. NIH Grant/Contract)

NCI-V00-1612

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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