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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

Fractionated Stereotactic Body Radiosurgery for Extracranial Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006456
• Other study ID #: CDR0000068151
• Secondary ID: P30CA016059MCV-M
• Status: Completed
• Phase: Phase 2
• First received: November 6, 2000
• Last updated: February 23, 2010
• Start date: February 1999
• Est. completion date: November 2004

Study information

• Verified date: February 2010
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2004
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Radiation:
• stereotactic radiosurgery

Locations

Country	Name	City	State
United States	Massey Cancer Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,