Skip to main content
OpenTrials
Completed

NCT Number: NCT01218542

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University Hospital Midtown, Atlanta, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Volumetric modulated arc therapy

Radiation

Using volumetric modulated arc therapy to give simultaneous infield boost to gross metastatic brain lesions during whole brain radiation therapy.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Overall Survival

    Time frame: 11 months median follow up period.

    Defined time from study entry to death from any cause.

  3. 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.

  4. 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)

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
Oct 11, 2010
Registry last updated
Jun 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.