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

Primary Purpose

Liver Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Tomotherapy treatment

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring Liver Cancer, Metastatic Liver Cancer, Tomotherapy, Stereotactic Body Radiation Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of New Mexico Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tomotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Tumor Response Rate (Complete Response + Partial Response).

Secondary Outcome Measures

Toxicity, Progression Free Survival, Clinical Benefit Rate (Complete Response + Partial Response + Stable Disease), Median Duration of Clinical Benefit, and Median Overall Survival of Subjects.

Full Information

NCT ID

NCT01030757

First Posted

December 9, 2009

Last Updated

June 13, 2015

Sponsor

New Mexico Cancer Care Alliance

1. Study Identification

Unique Protocol Identification Number

NCT01030757

Brief Title

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

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Terminated

Why Stopped

Low accrual rate

Study Start Date

June 2009 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

New Mexico Cancer Care Alliance

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Cancer

Keywords

Liver Cancer, Metastatic Liver Cancer, Tomotherapy, Stereotactic Body Radiation Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tomotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Tomotherapy treatment

Intervention Description

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%

Primary Outcome Measure Information:

Title

Tumor Response Rate (Complete Response + Partial Response).

Time Frame

1 year

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ben Liem, MD

Organizational Affiliation

University of New Mexico Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of New Mexico Cancer Center

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.cancer.unm.edu

Description

University of New Mexico Cancer Center

URL

http://www.nmcca.org

Description

New Mexico Cancer Care Alliance

Learn more about this trial

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

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