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Brain CancerPhase 2NCT01854554

Glioblastoma Multiforme (GBM) Proton vs. Intensity Modulated Radiotherapy (IMRT)

A Phase 2 study testing IMPT, IMRT and Cognitive Tests in people with Brain Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical research study is to compare IMRT with IMPT in patients with glioblastoma. Researchers want to learn about cognitive side effects (mental status changes) that may occur, such as memory loss and impaired thinking. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Cancer
What is being tested?
IMPT, IMRT and Cognitive Tests
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
17 May 2013to 13 Oct 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histological diagnosis of: Glioblastoma or Gliosarcoma (WHO Grade IV) adapted RPA class III, IV, or V.
  • All patients must be >/=18 years of age.
  • All patients must sign informed consent verifying that they are aware of the investigational nature of this study in keeping with the rules and policies of MD Anderson Cancer Center. The only acceptable consent form is the one approved by MD Anderson IRB.
  • All patients must have a baseline Mini Mental Status Examination score >/=21.
  • All patients must have a KPS >/=70.
  • All patients must be eligible to have either IMRT or IMPT as determined by the study radiation oncologist.
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  • All patients must be able to undergo MRI with and without contrast with a glomerular filtration rate (eGFR) greater than or equal to 30 mg/min/1.72 m2.
  • All patients must have adequate liver, renal, and hematologic function within 14 days of registration as defined by Aspartate Amino Transferase (AST)/Alanine Amino Transferase (ALT)/Alkaline Phosphatase < 3 times normal, creatinine </=1.7 mg/dl, BUN </= 35mg/dl, absolute neutrophil count >/=1,800 cells/mm3, Hemoglobin >/= 10 g/dl, and platelet count > 100,000.
  • All patients must be able to adequately read, write and speak to participate in the cognitive and quality of life assessments. However mild to moderate deficits in these functions due to tumor are allowed.

Who cannot join

  • Patients will be excluded if they are not planning to receive concurrent temozolomide.
  • Patients will be excluded if they have had prior radiation to the brain.
  • Patients will be excluded if they have had prior surgical resection of brain for other brain tumors.
  • Patients will be excluded if they are pregnant as assessed by serum beta human chorionic gonadotropin (b-HCG). A serum b-HCG test will be performed no greater than 14 days prior to study registration for women of childbearing potential.
  • Patients with gliomatosis will be excluded.
  • Patients with Gliadel bis-chloroethylnitrosourea (BCNU) implanted wafers will be excluded.
  • Patients weighing greater than 136 kilograms will be excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Prospective Phase II Randomized Trial to Compare Intensity Modulated Proton Radiotherapy (IMPT) vs. Intensity Modulated Radiotherapy (IMRT) for Newly Diagnosed Glioblastoma (WHO Grade IV)

The goal of this clinical research study is to compare IMRT with IMPT in patients with glioblastoma. Researchers want to learn about cognitive side effects (mental status changes) that may occur, such as memory loss and impaired thinking.

IMRT is the delivery of focused radiation therapy using photon beams and advanced computer planning to help shape the dose in order to give the highest possible dose to the tumor with the least dose to surrounding normal tissues.

IMPT is also focused radiation therapy similar to IMRT, but it uses proton particles to deliver the radiation instead of photon beams. IMPT also uses advanced computer planning in order to shape the dose to the target with the least dose to surrounding normal tissues.

Read the detailed description

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group.

If you are in Group 1, you will receive IMRT.

If you are in Group 2, you will receive IMPT.

Radiation Therapy:

In both groups, you will receive radiation treatments each day, Monday-Friday, starting on Day 1. You will continue to receive radiation treatment until you have completed 30 total treatments. This is a total of up to 6 weeks of treatment.

You will sign a separate consent form for the IMRT or IMPT that will explain the procedures and risks in detail.

Study Visits:

Before beginning radiation, you will have what is called a "simulation" to plan your radiation. During the simulation, you will be flat on your back on a computed tomography (CT) table and a soft plastic mask will be made to help hold your head still during treatment. This is the position you will be in when you receive radiation treatment. You will then have a CT scan, which will make computerized images to help plan your treatment.

At Month 2 (+/- 30 days):

  • You will have a physical exam, including measurement of your vital signs.
  • You will have an MRI to check the status of the disease.
  • You will be asked about any drugs you may be taking and side effects you may be having.
  • You will complete the thinking skills tests and the questionnaires about your quality of life and symptoms.

Length of Treatment:

You may receive up to 6 weeks of radiation therapy. You will no longer be able to receive radiation therapy if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your active participation on the study will be over after the follow-up visits.

Follow-Up:

At Month 4 (+/- 30 days) and then every 2 months for up to 2 years after radiation therapy:

  • You will have a physical exam, including measurement of your vital signs.
  • You will be asked about any side effects you may be having.
  • You will have an MRI to check the status of the disease.
  • You will complete the thinking skills tests and the questionnaires about your quality of life and symptoms.

Starting 2 years after radiation therapy, the study staff will continue checking your medical record to find out about your health status from then on.

This is an investigational study. IMRT is delivered using FDA-approved and commercially available methods. IMPT is investigational.

Up to 90 participants will be enrolled in this study. All will be enrolled at MD Anderson.

Conditions
Brain Cancer
Being tested
IMPT, IMRT, Cognitive Tests, Questionnaires
Keywords
Brain cancer, Glioblastoma, Glioblastoma Multiforme, GBM, Intensity Modulated Proton Radiotherapy, IMPT, Intensity Modulated Radiotherapy, IMRT, Radiotherapy, XRT, Cognitive tests, Thinking skills tests, Questionnaires, Surveys, Quality of life, QOL
Medical subject headings
Brain Neoplasms, Glioblastoma

What participants receive

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

  • IMPTRadiation

    Also called Radiotherapy, XRT

    IMPT treatments delivered as once daily fractions, 5 days per week Monday - Friday for 30 treatments.

  • IMRTRadiation

    Also called Radiotherapy, XRT

    IMRT treatments delivered as once daily fractions, 5 days per week Monday - Friday for 30 treatments.

  • Cognitive TestsBehavioural

    Also called Thinking skills tests

    Cognitive tests given at baseline, 4 months, then every 2 months for 2 years.

  • QuestionnairesBehavioural

    Also called Surveys

    Questionnaires about quality of life and symptoms given at baseline, 4 months, then every 2 months for 2 years.

Study groups in NCT01854554
Study groupRoleWhat they receive
Intensity Modulated Proton Radiotherapy (IMPT)ExperimentalIMPT treatments delivered as once daily fractions, 5 days per week Monday - Friday for 30 treatments.
Receives: Radiation: IMPT; Behavioral: Cognitive Tests; Behavioral: Questionnaires
Intensity Modulated Radiotherapy (IMRT)ExperimentalIMRT treatments delivered as once daily fractions, 5 days per week Monday - Friday for 30 treatments.
Receives: Radiation: IMRT; Behavioral: Cognitive Tests; Behavioral: Questionnaires

What is being measured

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

  1. Time to Cognitive Failure

    Time to cognitive failure on any of 6 primary variables from pre-specified cognitive tests (HVLT-R total recall, HVLT-R delayed recall, HVLT-R delayed recognition, TMT Part A or Part B, COWA) with failure defined as a decline that meets or exceeds the reliable change index (RCI) for each cognitive test variable. A cumulative incidence approach used to estimate median time to cognitive failure in order to account for the competing risks of disease progression and death.

    Measured: baseline, 4 months, then every 2 months for 2 years

Secondary outcomes (3)

  1. Overall Survival

    Overall survival time is defined as time from registration/randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

  2. Progression Free Survival (PFS)

    Measured from date of registration to date of first observation of progressive disease, symptomatic deterioration or death due to any cause. Participants last known to be alive and progression-free are censored at date of last contact.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

  3. Number of Participants Experienced Adverse Events by Maximum Grade (Grade 2 or Higher)

    The adverse severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.0).

    Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL

    Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL

    Grade 4 Life-threatening consequences; urgent intervention indicated.

    Count of participants experiencing adverse events. Should a participant experience multiple adverse events at different grades, the patient is counted only once at the highest grade.

    Measured: 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 posted15 May 2013 (estimated)
  2. Study start17 May 2013
  3. Primary completion13 Oct 2021
  4. Study completion13 Oct 2021

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01854554
Sponsor's protocol ID
2013-0097
Other IDs
NCI-2013-01089
Status last verified
Dec 2023
First submitted
13 May 2013
Last updated
2 Jan 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IMPT, IMRT and Cognitive Tests in people with Brain Cancer, run by M.D. Anderson 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 7 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: finished, as of the sponsor's last update on 2 Jan 2024. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time to Cognitive Failure (time frame: baseline, 4 months, then every 2 months for 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 NCT01854554.

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 2 Jan 2024.

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