Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver

Liver Cancer Clinical Trial

Official title:

Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01030757
• Other study ID #: INST 0819
• Secondary ID: NCI-2011-02945
• Status: Terminated
• Phase: Phase 2
• First received: December 9, 2009
• Last updated: June 13, 2015
• Start date: June 2009
• Est. completion date: May 2013

Study information

• Verified date: June 2015
• Source: New Mexico Cancer Care Alliance
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Radiation:
• 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%

Locations

Country	Name	City	State
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
New Mexico Cancer Care Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Response Rate (Complete Response + Partial Response).		1 year	No
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.		1 year	Yes

External Links

•   New Mexico Cancer Care Alliance
•   University of New Mexico Cancer Center