Stereotactic Radiation Therapy in Treating Patients With Advanced Liver Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of Nebraska.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00607828
First received: February 1, 2008
Last updated: March 23, 2010
Last verified: March 2010
  Purpose

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 advanced liver cancer.


Condition Intervention Phase
Liver Cancer
Radiation: stereotactic body radiation therapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility of Hypofractionated Stereotactic Radiotherapy in Patients With Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: Up to 1 month after SRT ] [ Designated as safety issue: Yes ]
  • Maximum tolerated dose [ Time Frame: At least 1 month of observation after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 28
Study Start Date: November 2007
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: stereotactic body radiation therapy
    Undergo radiotherapy
Detailed Description:

OBJECTIVES:

Primary

  • To determine the safety of hypofractionated stereotactic radiotherapy (SRT) in patients with advanced hepatocellular carcinoma.

Secondary

  • To determine the maximum tolerated dose of SRT in these patients.
  • To determine the objective tumor response rate in terms of the percentage of tumor size change on CT, percentage of intensity change on MRI, and the percentage of change in alfa fetoprotein in patients treated with this therapy.
  • To determine the value of 4-dimensional CT in liver cancer planning in terms of the extent of liver motion (three dimensionally) and the percentage of patients requiring breath gating due to the amplitude of organ motion exceeding 1 cm in any dimension.
  • To determine the value of breath gating in liver cancer SRT in terms of the success rate of breath gating and the percentage of treatment time prolongation secondary to the gating.

OUTLINE: Patients undergo hypofractionated stereotactic radiotherapy once daily on days 1-5.

After completion of study therapy, patients are followed at 1 and 3 months.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed advanced hepatocellular carcinoma (HCC)
  • Measurable disease, defined as ≥ 1 unidimensionally target lesion that can be accurately measured by CT scan or MRI according to RECIST and must have a maximum diameter ≤ 8 cm
  • No known CNS tumors, including metastatic brain disease
  • Child-Pugh class A-B cirrhotic status

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • Life expectancy ≥ 12 weeks
  • WBC ≥ 2,000/μL
  • Platelet count ≥ 60,000/mm³
  • Hemoglobin ≥ 8.5 g/dL
  • INR ≤ 2.3
  • No malignancy within the past 3 years that is distinct in its primary site or histology from HCC, except for carcinoma in situ of the cervix, treated basal cell carcinoma, or superficial bladder tumors (i.e., Ta, Tis, and T1), or any other cancer that has been curatively treated > 3 years prior to study entry
  • No renal failure requiring hemodialysis or peritoneal dialysis
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:

    • Ongoing or active infection > grade 2
    • NYHA class II-IV congestive heart failure
    • Active coronary artery disease
    • Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
    • Uncontrolled hypertension
    • Condition that could jeopardize the safety of the patient or study compliance
  • More than 6 months since prior myocardial infarction
  • No history of variceal bleeding where the varices have not been eradicated or decompressed by shunt placement
  • No condition that would prevent the patient from undergoing marker implantation
  • Not pregnant or nursing
  • Negative pregnancy test
  • No substance abuse, medical, psychological, or social condition that may interfere with the patient's participation in the study or evaluation of the study results

PRIOR CONCURRENT THERAPY:

  • Prior systemic chemotherapy allowed
  • At least 6 weeks since prior non-radiation local therapy (e.g., surgery, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation)
  • No prior radiotherapy to the liver
  • Concurrent therapeutic anticoagulation (e.g., warfarin or heparin) allowed provided that no prior evidence of underlying abnormality in PT, PTT, INR exists
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607828

Locations
United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-6805
Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ    800-999-5465      
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Chi Lin, MD, PhD University of Nebraska
  More Information

Additional Information:
No publications provided

Responsible Party: Chi Lin, M.D., UNMC Eppley Cancer Center at the University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00607828     History of Changes
Other Study ID Numbers: 337-07, P30CA036727, UNMC-33707
Study First Received: February 1, 2008
Last Updated: March 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
adult primary hepatocellular carcinoma
advanced adult primary liver cancer
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 20, 2014