Liver Cancer
Conditions
Keywords
Liver Cancer, Metastatic Liver Cancer, Tomotherapy, Stereotactic Body Radiation Therapy
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.
Interventions
RADIATIONTomotherapy 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 * Dose homogeneity +/- 5%
Sponsors
New Mexico Cancer Research Alliance
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor Response Rate (Complete Response + Partial Response). | 1 year |
Secondary
| 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. | 1 year |
Countries
United States
Participant flow
Recruitment details
8 subjects were screened; 6 did not meet entry criteria. 2 subjects were enrolled
Participants by arm
| Arm | Count |
|---|---|
| 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.
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
* Dose homogeneity +/- 5% | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Tomotherapy |
|---|---|
| Age, Continuous | 73 years |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Tumor Response Rate (Complete Response + Partial Response).
Time frame: 1 year
Population: Study was terminated due to low accrual; no results to report
Secondary
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
Population: Study was terminated due to low accrual; no results to report.