Clinical trial NCT01030757: Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver
Official title: Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Liver Cancer
Keywords: Liver Cancer
Metastatic Liver Cancer
Tomotherapy
Stereotactic Body Radiation Therapy
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
First posted: 2009-12-11
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the response of liver tumors to radiation therapy using Tomotherapy.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tumor Response Rate (Complete Response + Partial Response).
timeFrame: 1 year
Secondary outcomes:
measure: Toxicity, Progression Free Survival, Clinical Benefit Rate (Complete Response + Partial Response + Stable Disease), Median Duration of Clinical Benefit, and Median Overall Survival of Subjects.
timeFrame: 1 year
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
Study officials:
affiliation: University of New Mexico Cancer Center
name: Ben Liem, MD
role: PRINCIPAL_INVESTIGATOR
References: