Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

NCT00567970 | Completed Phase 1 DMC

• 4 other identifiers: CDR0000579232P30CA015083MC064206-004336
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Stereotactic radiation therapy 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 radiation therapy in treating patients with liver metastases.

Conditions

Metastatic Cancer

Keywords

liver metastases

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose

Secondary Outcomes (5)

• Toxicity profile

• Adverse events profile

• Quality of life as measured by the Brief Pain Inventory and Brief Fatigue Inventory

• Response profile

• Physical exam results

Interventions

quality-of-life assessment PROCEDURE

stereotactic body radiation therapy RADIATION

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Metastatic liver lesion ≤ 5 cm in dimension * Willing and able to undergo percutaneous placement of localization seeds PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy ≥ 12 weeks * Platelet count ≥ 75,000/µL * Hemoglobin ≥ 9 g/dL * ANC ≥ 1,500/mL * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) * AST ≤ 3 x ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to complete questionnaires alone or with assistance * No medical, social, or economic circumstance, that is likely to prevent adherence with the protocol PRIOR CONCURRENT THERAPY: * No prior radiation therapy to the liver * No chemotherapy ≤ 4 weeks prior to registration * Able to safely go without chemotherapy for 4 weeks after stereotactic radiotherapy (e.g., patients must not have or need chemotherapy in the 8 weeks \[4 weeks prior to and 4 weeks after registration\] surrounding stereotactic radiotherapy

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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, 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

• Laura A. Vallow, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2007
• First Posted: December 5, 2007
• Study Start: April 2, 2007
• Primary Completion: February 2, 2009
• Study Completion: April 21, 2016
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

US (1)