- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01030757
Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver
June 13, 2015 updated by: New Mexico Cancer Care Alliance
Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver
The purpose of this study is to determine the response of liver tumors to radiation therapy using Tomotherapy.
Study Overview
Detailed Description
The purpose of this study is to determine the response of liver tumors to radiation therapy.
This study will be using a type of radiation therapy called tomotherapy.
Tomotherapy is a relatively new kind of therapy which is able to focus a large amount of radiation to a small area with relatively less radiation to the surrounding non-cancerous part of the organ.
This study is being done to find out if this technique is able to control the cancer better or not than the standard radiation and also to study its safety.
The usual treatment for this type of disease for patients who are eligible is surgery to remove the tumors.
For patients who aren't eligible for surgery or who chose not to have surgery, they are treated with low daily doses of radiation given over many weeks; however this type of treatment has not been very effective.
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Mexico
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Albuquerque, New Mexico, United States, 87106
- University of New Mexico Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tomotherapy
Intervention: Stereotactic Body Radiation Therapy using Tomotherapy.
Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days.
Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours.
Dose will be prescribed to the isodose line which covers at least 90% of the PTV.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Tumor Response Rate (Complete Response + Partial Response).
Time Frame: 1 year
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1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ben Liem, MD, University of New Mexico Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
December 9, 2009
First Submitted That Met QC Criteria
December 9, 2009
First Posted (Estimate)
December 11, 2009
Study Record Updates
Last Update Posted (Estimate)
July 7, 2015
Last Update Submitted That Met QC Criteria
June 13, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INST 0819
- NCI-2011-02945 (Registry Identifier: NCI CTRP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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