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Malignant Neoplasm, BrainNCT04069910

Stereotactic Radiation Therapy Before Surgery for the Treatment of Resectable Brain Metastases

A study testing Quality-of-Life Assessment, Questionnaire Administration and Stereotactic Radiosurgery in people with Malignant Neoplasm, Brain and Brain Tumor, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This trial studies how well stereotactic radiation therapy before surgery works in treating patients with cancer that has spread to the brain (brain metastases) and can be removed by surgery (resectable). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Neoplasm, Brain, Brain Tumor
What is being tested?
Quality-of-Life Assessment, Questionnaire Administration and Stereotactic Radiosurgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
26 Aug 2019to 30 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies
  • 1?4 cerebral metastases per magnetic resonance imaging (MRI) with at least 1 being dominant and eligible for resection
  • No prior radiation treatment for the index brain metastases
  • Systemic disease staged within previous 8 weeks and not rapidly progressing, with concern of life expectancy > 3 months
  • The patients will have been evaluated by the multidisciplinary team, and surgery must be deemed necessary as a result of indications including but not limited to mass effect or symptomatic lesion. Surgery must be deemed non?emergent or non?urgent clinically by the neurosurgeon
  • Karnofsky performance status (KPS) >= 70
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  • No active infections requiring systemic antibiotics
  • If a woman is of childbearing potential, a negative serum pregnancy test must be documented. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study treatment
  • Ability to understand and willingness to sign a written informed consent

Who cannot join

  • Patient deemed medically unfit to undergo surgical resection of brain metastasis
  • Prior whole brain radiotherapy
  • Patient with contraindication for imaging with MRI
  • Surgery is considered emergent or urgent by the neurosurgeon due to symptoms or concerning mass effect noted on imaging
  • Patients who are participating in a concurrent treatment protocol
  • At the time of planning, unable to meet dose tolerance of the optic nerve/chiasm
Show all 9Show fewer
  • Tumor located in the brainstem
  • Imaging or cytologic evidence of leptomeningeal disease
  • Concurrent uncontrolled illness including, but not limited to, any of the following: Symptomatic congestive heart failure, unstable angina pectoris, psychiatric illness

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Neoadjuvant Stereotactic Radiation Therapy for Resectable Brain Metastases

This trial studies how well stereotactic radiation therapy before surgery works in treating patients with cancer that has spread to the brain (brain metastases) and can be removed by surgery (resectable). Stereotactic radiation therapy is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor, and may cause less damage to normal tissue. Giving stereotactic radiation therapy before surgery may make the return of brain metastases less likely and help patients live longer compared to surgery followed by radiation therapy.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the rate of leptomeningeal failure after neoadjuvant radiation therapy (NaRT) versus (vs) postoperative stereotactic radiosurgery (SRS)/stereotactic radiation therapy (SRT).

SECONDARY OBJECTIVES:

  1. Local control of brain metastases. II. Rate of salvage treatment including surgery, SRS, SRT, or whole brain radiation therapy (WBRT).

III. Dose and volume of radiation to adjacent normal brain parenchyma. IV. Rate of symptomatic radiation necrosis/steroid dependency. V. Rate of distant brain failure. VI. To compare overall survival (OS) between the 2 groups. VII. To determine the number of patients who die due to neurologic causes. VIII. To assess quality of life as assessed using Functional Assessment of Cancer Therapy?Brain (FACT?BR).

IX. To evaluate and compare the molecular makeup of tumor tissue in pre vs post radiation settings and determine differences in molecular and germline markers.

  1. To evaluate biomarkers and germline markers predicting response.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients undergo 1, 5, or 10 fraction of SRS/SRT radiation. Surgery is performed within 72 hours of radiation therapy.

ARM B: Within 2-5 weeks after standard of care surgery, patients undergo 1, 5, or 10 fraction of SRS/SRT.

After completion of study treatment, patients are followed up every 3 months.

Being tested
Quality-of-Life Assessment, Questionnaire Administration, Stereotactic Radiosurgery, Therapeutic Conventional Surgery
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Stereotactic RadiosurgeryRadiation

    Also called Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, stereotactic radiation therapy, Stereotactic Radiotherapy

    Undergo SRS/SRT

  • Therapeutic Conventional SurgeryProcedure or surgery

    Undergo standard of care surgery

Study groups in NCT04069910
Study groupRoleWhat they receive
Arm A (SRS/SRT, surgery)ExperimentalPatients undergo 1, 5, or 10 fraction of SRS/SRT radiation. Surgery is performed within 72 hours of radiation therapy.
Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Radiosurgery; Procedure: Therapeutic Conventional Surgery
Arm B (surgery, SRS/SRT)Active comparatorWithin 2-5 weeks after standard of care surgery, patients undergo 1, 5, or 10 fraction of SRS/SRT.
Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Radiosurgery; Procedure: Therapeutic Conventional Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of leptomeningeal failure

    A two-sided Z test with pooled variance will be used at significance level =0.1 to test if there is a difference in leptomeningeal failure rate between the two treatment groups.

    Measured: Up to 2 years

Secondary outcomes (9)

  1. Time to progression

    Local control of brain metastases is defined as tumor has not progressed or recurred with no radiographic or symptomatic progression. Using the Response Assessment in Neuro-Oncology (RANO) criteria for brain metastases, progressive disease will be defined as > 20% increase in the sum of the longest diameters of the target lesions; unequivocal progression of enhancing non?target lesions; new lesions; or substantial clinical decline. Will be compared using t test for continuous outcomes, log rank test for time?to?event outcomes and Z test for binary outcomes.

    Measured: Up to 2 years

  2. Rate of salvage treatment including surgery, SRS, SRT, or WBRT

    Will be compared using t test for continuous outcomes, log rank test for time?to?event outcomes and Z test for binary outcomes.

    Measured: Up to 2 years

  3. Dose (Gy) and volume (cc) of radiation to adjacent normal brain parenchyma

    Will be compared using t test for continuous outcomes, log rank test for time-to-event outcomes and Z test for binary outcomes.

    Measured: Up to 2 years

  4. Rate of symptomatic radiation necrosis/steroid dependency

    Will be compared using t test for continuous outcomes, log rank test for time?to?event outcomes and Z test for binary outcomes.

    Measured: Up to 2 years

  5. Rate of distant brain failure

    Will be compared using t test for continuous outcomes, log rank test for time?to?event outcomes and Z test for binary outcomes.

    Measured: Up to 2 years

  6. Overall survival (OS)

    Will be compared using t test for continuous outcomes, log rank test for time?to?event outcomes and Z test for binary outcomes.

    Measured: Up to 2 years

  7. Death due to neurological causes

    Will be compared using t test for continuous outcomes, log rank test for time?to?event outcomes and Z test for binary outcomes.

    Measured: Up to 2 years

  8. Quality of life assessment: FACTBR

    Assessed using Functional Assessment of Cancer Therapy-Brain (FACTBR). Will be compared using t test for continuous outcomes, log rank test for time?to?event outcomes and Z test for binary outcomes. The scale is 0 - 4, 0 = "not at all", 4 = "very much". Overall higher ratings mean higher quality of life.

    Measured: Up to 2 years

  9. Genetic expression profiles in pre vs post radiation tumor tissue

    Will be compared using t test for continuous outcomes, log rank test for time?to?event outcomes and Z test for binary outcomes.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start26 Aug 2019
  3. Primary completion30 Nov 2020
  4. Study completion30 Nov 2020

Why it stopped: no enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04069910
Sponsor's protocol ID
17-000082
Other IDs
NCI-2019-05337
Status last verified
Sep 2020
First submitted
21 Aug 2019
Last updated
31 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Quality-of-Life Assessment, Questionnaire Administration and Stereotactic Radiosurgery in people with Malignant Neoplasm, Brain and Brain Tumor, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of leptomeningeal failure (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04069910.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022.

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