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Stereotactic Radiation Therapy in Treating Patients With Advanced Liver Cancer

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ClinicalTrials.gov Identifier: NCT00607828
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : September 26, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Chi Lin, MD, University of Nebraska

Study Description
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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 advanced liver cancer.


Condition or disease Intervention/treatment Phase
Liver Cancer Radiation: stereotactic body radiation therapy Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of Hypofractionated Stereotactic Radiotherapy in Patients With Hepatocellular Carcinoma
Study Start Date : November 2007
Actual Primary Completion Date : February 15, 2017
Actual Study Completion Date : February 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arms and Interventions
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Intervention Details:
  • Radiation: stereotactic body radiation therapy
    Undergo radiotherapy

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

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607828


Locations
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United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6805
Sponsors and Collaborators
University of Nebraska
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Chi Lin, MD, PhD University of Nebraska
More Information
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Responsible Party: Chi Lin, MD, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT00607828    
Other Study ID Numbers: 337-07
P30CA036727 ( U.S. NIH Grant/Contract )
UNMC-33707
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: August 2017
Keywords provided by Chi Lin, MD, 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:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Liver Diseases