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

NCT01862718 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-08-15

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Bradford J Wood, M.D. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-19
Primary Completion
2017-11-02
Completion
2019-11-05

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01862718 on ClinicalTrials.gov