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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 March 2013 |
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Main ID: |
NCT01030757 |
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Date of registration:
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09/12/2009 |
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Primary sponsor: |
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Public title:
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Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver
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Scientific title:
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Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver |
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Date of first enrolment:
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June 2009 |
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Target sample size:
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2 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01030757 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Ben Liem, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of New Mexico Cancer Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histologic confirmation of solid primary tumor metastatic to liver
- Age greater than or equal to 18 years old
- Zubrod performance status less than or equal to 1
- Negative pregnancy test for women of child bearing potential
- Informed consent
- Less than or equal to 3 liver metastases
- Each lesion must be less than or equal to 6 cm in maximal diameter
- No prior radiation to lesions being treated
- Patient is not a surgical candidate or refuses surgery
- Absolute neutrophil count = 1800
- Platelets = 100000
- Hemoglobin =8.0
- Systemic therapy (chemotherapy) completed at least 2 weeks prior to SBRT
- At time of radiation treatment planning, at least 700 cc of normal liver must receive
less than 15 Gy
Exclusion Criteria:
- Contraindications to radiation
- Pregnant or lactating females who chose to breast feed
- Patients must have recovered from toxicity of prior therapy
- Any co morbid condition that' in the view of the attending physician' renders the
patient at high risk from treatment complications
- Patients currently receiving anticoagulation with coumadin or IV heparin
- Liver cirrhosis
- Clinical ascites
- Bilirubin > 3, Albumin < 2.5, liver enzymes 3 times above normal, Creatinine > 1.8
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Liver Cancer
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Intervention(s)
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Radiation: Tomotherapy treatment
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Primary Outcome(s)
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The primary efficacy endpoint of this study is tumor response rate (complete response + partial response).
[Time Frame: 1 year]
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Secondary Outcome(s)
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The secondary endpoints of this study are toxicity, progression free survival, clinical benefit rate (complete response + partial response + stable disease), median duration of clinical benefit, and median overall survival of subjects.
[Time Frame: 1 year]
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Secondary ID(s)
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INST 0819
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NCI-2011-02945
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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