Fusion Guided Thermal Ablation Combined With External Beam Radiation for Hepatic Neoplasms

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01862718
First received: May 23, 2013
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

Background:

Pilot study to assess feasibility for combining treatment modalities that should be synergistic (radiation and thermal ablation).

Thermal ablation with Radiofrequency Ablation (RFA) and microwave ablation (MWA) are standard treatments for focal neoplasms in the liver.

High volume or scattered locations of tumor burden results in inability to successfully use this technology for a large proportion of patients with hepatic neoplasms.

Methods to enhance treatment volumes could be advantageous in potentially increasing the indications for thermal ablation or the number of patients benefitting from local ablation.

Primary objective:

To determine the safety of combining 2 standard therapies (thermal ablation and external beam radiation therapy) for liver neoplasms up to 10 cm diameter.

Eligibility:

Patients greater than 18 years of age with pathologically proven unresectable primary or metastatic hepatic neoplasms

Patients whose extent of hepatic metastases represents approximately less than 60% of total liver volume AND whose extrahepatic metastatic disease is determined to be minimal

ECOG performance status of less than or equal to 2 and a life expectancy of more than 3 months

Patients with a history of chemotherapy, radiation therapy, or biological therapy for at least 4 weeks prior to starting study treatments, and 4 weeks after treatments Patients must not have an acute, critical illness

If clinical or imaging evidence for cirrhosis present, then Bilirubin must be less than 3 mg/dl and Child-Pugh Classification A, (Class B & C are excluded)

Design:

Patients will undergo external beam radiation as well as thermal ablation according to standard operating procedures of the NCI and NIH CC.

Patients will be monitored using the standard imaging studies when clinically warranted.

Patients may be treated with a second (or more) thermal ablation procedure ALONE if it is deemed beneficial for the patient by the investigator.

The sample size will be 10 evaluable patients


Condition Intervention Phase
Liver Neoplasms
Hepatic Cancer
Liver Cancer
Procedure: Thermal Ablation
Procedure: Standard External Beam Radiation Therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fusion Guided Thermal Ablation Combined With External Beam Radiation for Hepatic Neoplasms

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Safety of Ablation plus radiation [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: February 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ablation plus radiation
Procedure: Thermal Ablation
On Thursday in the first week, subject will receive the radiofrequency ablation.
Procedure: Standard External Beam Radiation Therapy
During those 2 weeks, subject will receive radiation on Monday, Wednesday and Friday.

Detailed Description:

Background:

Pilot study to assess feasibility for combining treatment modalities that should be synergistic (radiation and thermal ablation).

Thermal ablation with Radiofrequency Ablation (RFA) and microwave ablation (MWA) are standard treatments for focal neoplasms in the liver.

High volume or scattered locations of tumor burden results in inability to successfully use this technology for a large proportion of patients with hepatic neoplasms.

Methods to enhance treatment volumes could be advantageous in potentially increasing the indications for thermal ablation or the number of patients benefitting from local ablation.

Primary objective:

To determine the safety of combining 2 standard therapies (thermal ablation and external beam radiation therapy) for liver neoplasms up to 10 cm diameter.

Eligibility:

Patients greater than 18 years of age with pathologically proven unresectable primary or metastatic hepatic neoplasms

Patients whose extent of hepatic neoplasms represents approximately less than 60% of total liver volume AND whose extrahepatic metastatic disease is determined to be minimal

ECOG performance status of less than or equal to 2 and a life expectancy of more than 3 months

Patients with a history of chemotherapy, radiation therapy to liver, or biological therapy must have had last dose/ treatment for at least 14 days prior to starting study treatments.

Patients must not have an acute, critical illness

If clinical or imaging evidence for cirrhosis present, then Bilirubin must be less than 3 mg/dl and Child-Pugh Classification A, (Class B & C are excluded)

Design:

Patients will undergo external beam radiation as well as thermal ablation according to standard operating procedures of the NCI and NIH CC.

Patients will be monitored using the standard imaging studies when clinically warranted.

Patients may be treated with a second (or more) thermal ablation procedure ALONE if it is deemed beneficial for the patient by the investigator.

The sample size will be 10 evaluable patients

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Patients with hepatic-dominant neoplasms where the life limiting component of the disease is hepatic neoplasms

Patients must have unresectable hepatic lesions or must be deemed unable or unadvisable to undergo surgical resection

Have 5 or fewer lesions and with no single lesion greater than 10 cm in maximum diameter

Patients with extrahepatic neoplasms or an unresected primary lesion will be considered eligible if the extrahepatic disease is minimal and stable

Serum Creatinine less than 2.0 mg/dl unless the measured creatinine clearance is greater than 60 ml/min.

Absolute neutrophil count (ANC) greater than or equal to1500/m3 without help of Filgastrim, hemoglobin greater than 8 g/dL, and platelet count greater than or equal to 75,000 m3

Bilirubin less than 3 mg/dl, and AST and ALT less than 5 X upper limit of normal except in the presence of obstructive liver neoplasms where ALT/AST may be up to 10 X the upper limit of normal.

Prothrombin Time (PT) within 2 seconds of the upper limit normal (INR less than 1.8)

Extent of hepatic neoplasms is approximately less than 60% of total hepatic volume

Patients must have pathology proof of neoplasm. If proof of pathology is unavailable, histopathological confirmation of liver neoplasm may not be requisite in the setting of clinical or radiological characteristics that are highly suggestive of a neoplastic diagnosis, with such designation determined by PI and a medical or surgical oncologist, with the NCI multidisciplinary gastrointestinal tumor board review, in the event of absence of such consensus.

Patients referred for ablation or radiation of liver neoplasm

ECOG performance status less than or equal to 2

Life expectancy greater than 3 months

At least 18 years of age

Age less than 85 years

Patients must have had no chemotherapy, radiotherapy, or biologic therapy for their malignancy for at least 28 days prior to treatment and must have recovered from all clinically significant side effects of therapeutic and diagnostic interventions.

EXCLUSION CRITERIA:

Portal Vein Occlusion or other contraindications to thermal ablation or radiation Prior selective internal radiation therapy (SIRT) with Yttrium-90 or prior radiation to the liver

Prior biliary diversion surgery

Patients requiring ongoing chronic anticoagulation will not be eligible.

Standard clinical screening procedures will be performed, and when it is clinically low-risk to do so, patients will be taken off of aspirin or NSAIDS for a week prior to RFA, as per clinical standard.

Patients with active bacterial infections with systemic manifestations (malaise, fever, leucocytosis) are not eligible until completion of appropriate therapy.

Any exclusion criteria for radiation or for ablation, such as ataxia telengiectasia, active connective tissue disease, or inflammatory bowel disease, or other known conditions which predispose to radiation toxicities

Patients with an acute, critical illness

Pregnant or nursing mothers will not be eligible

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01862718

Contacts
Contact: Charisse Garcia, R.N. (301) 594-4511 garciacr@mail.nih.gov
Contact: Bradford Wood, M.D. (301) 496-7739 bwood@mail.cc.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Bradford Wood, M.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01862718     History of Changes
Other Study ID Numbers: 130079, 13-CC-0079
Study First Received: May 23, 2013
Last Updated: September 12, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Fusion
Tracking
Ablation
Hepatic Neoplasms

Additional relevant MeSH terms:
Liver Neoplasms
Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms by Site

ClinicalTrials.gov processed this record on October 30, 2014