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

NCT ID: NCT01030757

Last Updated: 2015-07-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2013-05-31

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.

Conditions

Liver Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tomotherapy treatment

Intervention Type: RADIATION

• 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%

Interventions

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%

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New Mexico Cancer Research Alliance

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ben Liem, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico Cancer Center

Locations

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Countries

United States

Related Links

http://www.cancer.unm.edu

University of New Mexico Cancer Center

http://www.nmcca.org

New Mexico Cancer Care Alliance

Other Identifiers

NCI-2011-02945

Identifier Type: REGISTRY

Identifier Source: secondary_id

INST 0819

Identifier Type: -

Identifier Source: org_study_id