Whole Brain Radiation Therapy With Boost to Metastatic Tumor Volume Using RapidArc

June 25, 2021 updated by: Hui-Kuo Shu, MD, PhD, Emory University

Whole Brain Radiation Therapy With Simultaneous Boost to Gross Metastatic Tumor Volume Using Volumetric Modulated Arc Therapy (RapidArc)

Brain metastases are the most common adult intracranial tumor, occurring in approximately 10% to 30% of adult cancer patients, and represent an important cause of morbidity and mortality. The most widely used treatment for patients with multiple brain metastases is whole brain radiation therapy (WBRT). The use of WBRT after resection or stereotactic radiosurgery (SRS) has been proven to be effective in terms of improving local control of brain metastases.

RapidArc (RA) (Varian Medical Systems, Palo Alto, CA) is a new method of delivering radiation that uses "arcs" to deliver highly conformal intensity modulated three dimensional dose distributions. The purpose of this investigation is to evaluate an alternative strategy for giving WBRT with highly focal boost to gross visible lesions in patients with brain metastasis.

Given the limitations of the SRS boost technique, the purpose of our investigation is to evaluate an alternative strategy for giving WBRT with highly focal boost to gross visible lesions in patients with brain metastasis. In this study, we plan to assess the tolerability of using volumetric modulated arc therapy (RapidArc) on patients with brain metastasis to simultaneously treat the entire brain with a concomitant focal boost to grossly identified lesions on MRI scan to try to improve local control and reduce neurocognitive toxicities.

This previous version of this study was a phase I dose escalation trial giving 25 Gy in 10 fractions to the whole brain with simultaneous infield boost (SIB) to a total of 45 Gy in 10 fractions to gross brain metastatic disease. Prior to this, patients were enrolled onto one of two cohorts with whole brain dose of 30 Gy in 10 fractions with SIB to total of 45 Gy in 10 fractions to gross brain metastatic disease or whole brain dose of 37.5 Gy in 15 fractions with SIB to total of 52.5 Gy in 15 fractions to gross brain metastatic disease. A total of 12 patients have been previously enrolled on this trial. No patients have experienced a dose limiting toxicity (grade 3 or above) at least possibly due to study therapy. Also, no patients experienced local brain failure/progression at a site of treated metastatic brain disease. Based on this, we no longer feel that dose escalation to the gross brain disease is warranted and would proceed with a single arm pilot study treating patients with 25 Gy in 10 fractions to the whole brain with simultaneous infield boost (SIB) to a total of 45 Gy in 10 fractions to gross brain metastatic disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, United States, 30322
        • Emory University/Winship Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pathologic proven diagnosis of solid tumor malignancy.
  • Age ≥ 18.
  • KPS ≥ 70.
  • Mini Mental Status Exam (MMSE) ≥ 18 prior to study entry.
  • RPA class I (KPS ≥ 70, primary cancer controlled, age < 65, metastases in brain only) or class II (lack of one or more of class I criteria).
  • One to ten brain metastatic lesions.

Exclusion Criteria:

  • Previous whole brain radiation therapy.
  • Previous radiosurgery to any currently progressive gross metastatic disease.
  • Previous radiosurgery to any intracranial site within the prior 6 weeks.
  • Recursive partitioning analysis (RPA) class III (KPS < 70).
  • Radiosensitive (eg. small cell lung carcinomas, germ cell tumors, leukemias, or lymphomas) or unknown tumor histologies.
  • Concurrent chemotherapy (no chemotherapy starting 14 days before start of radiation).
  • Evidence of leptomeningeal disease by MRI and/or cerebrospinal fluid (CSF) cytology.
  • Current pregnancy.
  • No metastases to brain stem, midbrain, pons, or medulla or within 7 mm of the optic apparatus (optic nerves and chiasm).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Volumetric modulated arc therapy
Single arm pilot study treating patients with 25 Gy in 10 fractions to the whole brain with simultaneous infield boost (SIB) to a total of 45 Gy in 10 fractions to gross brain metastatic disease.
Radiation: Volumetric modulated arc therapy
Using volumetric modulated arc therapy to give simultaneous infield boost to gross metastatic brain lesions during whole brain radiation therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Participants With Locoregional Control of Treating Brain Metastasis Patients
Time Frame: Locoregional control at 1 year
The cumulative incidences of recurrence locally and in the whole brain were reported at the patient level.
Locoregional control at 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain Progression-free Survival
Time Frame: 11 months median follow up period.
Defined as period of time from study entry to to death from any cause or brain tumor recurrence or progression.
11 months median follow up period.
Overall Survival
Time Frame: 11 months median follow up period.
Defined time from study entry to death from any cause.
11 months median follow up period.
Neurocognitive Effects
Time Frame: 11 months median follow up period.

Neurological test score were assessed using the Hopkins Verbal Learning Test-Revised (HVLT).

In the HVLT 12 words are read and the participant is asked to recall them, this is completed 3 times.

Total words recalled are summed to give a score for Total Recall (0-36, higher scores demonstrated better recall).

Delayed recall is conducted 20-25 minutes later on the same list of 12 words (scored 0-12 with higher scores demonstrating better recall).

Retention is calculated as the percent of words recalled (scored 0-100, higher scores representing better recall).

Recognition Discrimination is tested by a series of yes/no responses from the participant identifying 12 target words from a list of 24 and calculated by the number of true positives minus the number of true negatives with higher scores indicating a better outcome.
11 months median follow up period.
Quality of Life as Measured by the FACT-Br Subscales
Time Frame: 11 month median follow up

The Functional Assessment of Cancer Therapy-Brain (FACT-Br) were summed to create the FACT brain trial outcome index (FACT-BR TOI), FACT general (FACT-G), and FACT brain total (FACT-BR Total).

Three FACT scales were calculated. The higher the value the better the score, i.e., the better the quality of life perceived by patient.

FACT BR TOTAL (FACT-G + BrCS, possible range 0 - 200) FACT-BR TOI (Trial Outcome Index = Physical Well Being _ Functional Well Being +BrCS, possible range 0 - 148) FACT-G (Fact General, possible range 0 - 108)
11 month median follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2010

Primary Completion (Actual)

June 3, 2020

Study Completion (Actual)

June 3, 2020

Study Registration Dates

First Submitted

September 30, 2010

First Submitted That Met QC Criteria

October 8, 2010

First Posted (Estimate)

October 11, 2010

Study Record Updates

Last Update Posted (Actual)

June 29, 2021

Last Update Submitted That Met QC Criteria

June 25, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00045035
  • WCI1784-10 (Other Identifier: Other)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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