Stereotactic Radiosurgery for Patients With Hepatic Metastases.

NCT00547677 | Completed Phase 1 DMC

• 2 other identifiers: CDR0000571611SCCC-062004-005
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with liver metastases.

Conditions

Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

liver metastases; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of stereotactic radiosurgery as assessed by NCI CTCAE v3.0

Interventions

stereotactic radiosurgery RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed primary cancer * Stage IV primary disease with up to five liver metastases that are visualized on CT scan, MRI of the abdomen, or positron-emission tomography * No liver metastases secondary to germ cell tumor or hematologic malignancy * Other sites of metastases allowed * No malignant ascites * The cumulative total dose of radiotherapy to ≥ 2/3 of the liver and surrounding normal tissues, including the esophagus, stomach, and small bowel, must be ≤ 15 Gy * Percutaneous or laparoscopic biopsy of the metastasis and placement of 3-5 fiducials required if undergoing Cyberknife for treatment delivery PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Life expectancy ≥ 3 months * Albumin ≥ 3 g/dL * Alkaline phosphatase \< 1.5 times upper limit of normal (ULN) * AST and ALT \< 1.5 times ULN * Total bilirubin \< 1.5 times ULN * Prothrombin time \< 1.5 times ULN * Hemoglobin \> 10 g/dL * Platelet count \> 100,000/mm³ * ANC \> 1,000/mm³ * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of diagnosed inflammatory bowel disease, such as ulcerative colitis or Crohn's disease * No active peptic ulcer disease * No hepato-renal syndrome PRIOR CONCURRENT THERAPY: * Prior systemic therapy allowed provided complete blood cell counts have recovered * No other concurrent antineoplastic treatment

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, 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

• Robert D. Timmerman, MD

  Simmons Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 19, 2007
• First Posted: October 22, 2007
• Study Start: July 1, 2004
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2008
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

US (2)