Clinical trial NCT00006456: Stereotactic Radiosurgery in Treating Patients With Liver Metastases, Lung Metastases, or Other Advanced Solid Tumors
Official title: Fractionated Stereotactic Body Radiosurgery for Extracranial Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
lung metastases
liver metastases
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Massey Cancer Center
state: Virginia
Study officials:
affiliation: Massey Cancer Center
name: Danny Y. Song, MD
role: STUDY_CHAIR
References: