Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver
18 Years
N/A
Both
Liver Cancer
Trial Information
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.
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary efficacy endpoint of this study is tumor response rate (complete response + partial response).
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Ben Liem, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of New Mexico Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
INST 0819
NCT ID:
NCT01030757
Start Date:
June 2009
Completion Date:
May 2014
Related Keywords:
- Liver Cancer
- Liver Cancer
- Metastatic Liver Cancer
- Tomotherapy
- Stereotactic Body Radiation Therapy
- Liver Neoplasms
- Neoplasm Metastasis
Name | Location |
|---|---|
| University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
