Study Stopped
Low accrual rate
Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver
Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver
2 other identifiers
interventional
2
1 country
1
Brief Summary
The purpose of this study is to determine the response of liver tumors to radiation therapy using Tomotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2009
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 9, 2009
CompletedFirst Posted
Study publicly available on registry
December 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
July 7, 2015
CompletedJuly 7, 2015
June 1, 2015
3.9 years
December 9, 2009
June 13, 2015
June 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tumor Response Rate (Complete Response + Partial Response).
1 year
Secondary Outcomes (1)
Toxicity, Progression Free Survival, Clinical Benefit Rate (Complete Response + Partial Response + Stable Disease), Median Duration of Clinical Benefit, and Median Overall Survival of Subjects.
1 year
Study Arms (1)
Tomotherapy
EXPERIMENTALIntervention: 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.
Interventions
* 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 * Dose homogeneity +/- 5%
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ben Liem, MD
- Organization
- University of New Mexico
Study Officials
- PRINCIPAL INVESTIGATOR
Ben Liem, MD
University of New Mexico Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2009
First Posted
December 11, 2009
Study Start
June 1, 2009
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
July 7, 2015
Results First Posted
July 7, 2015
Record last verified: 2015-06