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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-02-28

Study Completion Date

2004-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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stereotactic radiosurgery

Intervention Type RADIATION

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No