Stereotactic Radiosurgery in Treating Patients With Liver Metastases, Lung Metastases, or Other Advanced Solid Tumors
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Radiation: stereotactic radiosurgery |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Fractionated Stereotactic Body Radiosurgery for Extracranial Tumors |
| Enrollment: | 26 |
| Study Start Date: | February 1999 |
| Study Completion Date: | November 2004 |
| Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Virginia | |
| Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0058 | |
| Study Chair: | Danny Y. Song, MD | Massey Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Danny Song, MD, Virginia Commonwealth University/Massey Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00006456 History of Changes |
| Other Study ID Numbers: | CDR0000068151, P30CA016059, MCV-MCC-9812-2C, NCI-V00-1612 |
| Study First Received: | November 6, 2000 |
| Last Updated: | February 23, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Virginia Commonwealth University:
|
unspecified adult solid tumor, protocol specific lung metastases liver metastases |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013