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

Primary Purpose

Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
stereotactic radiosurgery
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring unspecified adult solid tumor, protocol specific, lung metastases, liver metastases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massey Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 6, 2000
Last Updated
February 23, 2010
Sponsor
Virginia Commonwealth University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006456
Brief Title
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

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
February 1999 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
November 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
unspecified adult solid tumor, protocol specific, lung metastases, liver metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
stereotactic radiosurgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danny Y. Song, MD
Organizational Affiliation
Massey Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0058
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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