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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT01030757
First received: December 9, 2009
Last updated: May 2, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Liver Cancer
 Radiation: Tomotherapy treatment
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer
U.S. FDA Resources

Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • The primary efficacy endpoint of this study is tumor response rate (complete response + partial response). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary endpoints of this study are 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 ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: June 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tomotherapy
Stereotactic Body Radiation Therapy using Tomotherapy
 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%

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030757

Locations
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
Principal Investigator: Ben Liem, MD University of New Mexico Cancer Center
  More Information

Additional Information:
University of New Mexico Cancer Center  This link exits the ClinicalTrials.gov site
New Mexico Cancer Care Alliance  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT01030757     History of Changes
Other Study ID Numbers: INST 0819, NCI-2011-02945
Study First Received: December 9, 2009
Last Updated: May 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New Mexico Cancer Care Alliance:
Liver Cancer
Metastatic Liver Cancer
Tomotherapy
Stereotactic Body Radiation Therapy

Additional relevant MeSH terms:
Liver Neoplasms
Neoplasm Metastasis
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Liver Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013