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

NCT00006456 | Completed Phase 2

• 4 other identifiers: CDR0000068151P30CA016059MCV-MCC-9812-2CNCI-V00-1612
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific; lung metastases; liver metastases

Interventions

stereotactic radiosurgery RADIATION

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massey Cancer Center

Richmond, Virginia, 23298-0058, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Danny Y. Song, MD

  Massey Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 6, 2000
• First Posted: January 27, 2003
• Study Start: February 1, 1999
• Primary Completion: November 1, 2004
• Study Completion: November 1, 2004
• Last Updated: February 24, 2010

Record last verified: 2010-02

Locations

US (1)