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Pilot Trial of Dose-Volume Constraints for Reirradiation of Recurrent Brain Tumors

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ClinicalTrials.gov Identifier: NCT02698254
Recruitment Status : Recruiting
First Posted : March 3, 2016
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:

The goal of this clinical research study is to test the safety of repeat radiation for brain tumors that came back after the first course of radiation. Researchers also want to learn how repeat radiation affects your quality of life.

This is an investigational study. Radiation will be provided according to routine clinical standards using FDA-approved and commercially available methods. The use of a second course of radiation is investigational.

Up to 40 participants will be enrolled in this multicenter study. All will take part at MD Anderson.


Condition or disease Intervention/treatment Phase
Brain Cancer Radiation: Re-Irradiation Therapy (RRT) to Brain Behavioral: Questionnaires Not Applicable

Detailed Description:

In this study, you will be treated with radiation. The type of radiation used to treat you will be determined by your doctor.

Radiation Therapy:

If you are found to be eligible to take part in this study, the dose of radiation will be decided by your radiation oncologist, using guidelines developed for this study. The dose will depend on your age, the type of tumor, your previous radiation treatment, and the amount of time that has passed since your last course of radiation.

You will sign a separate consent form for radiation treatment that will describe how the radiation will be administered and its risks in more detail.

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. This should take about 15 minutes.

You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.

Study Visits:

At Months 1, 3, 5, 7, 9, 11, 13, 16, 19, 22, and 25 after radiation therapy:

  • You will have a physical exam.
  • You will have an MRI to check the status of the disease.
  • You will complete 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.

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 last study visit (about 25 months after your radiation).


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Trial of Dose-Volume Constraints for Reirradiation of Recurrent Brain Tumors
Actual Study Start Date : July 20, 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arms and Interventions
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Arm Intervention/treatment
Experimental: Re-Irradiation Therapy (RRT) to Brain - Children

Participants may receive up to 6 weeks of radiation therapy. Dose of radiation decided by participant's radiation oncologist.

Quality of life and symptom questionnaires completed at baseline, and at months 1, 3, 5, 7, 9, 11, 13, 16, 19, 22, and 25 after radiation therapy.

 Radiation: Re-Irradiation Therapy (RRT) to Brain
Participants may receive up to 6 weeks of radiation therapy. Dose of radiation decided by participant's radiation oncologist.
Other Name: XRT

Behavioral: Questionnaires
Quality of life and symptom questionnaires completed at baseline, and at months 1, 3, 5, 7, 9, 11, 13, 16, 19, 22, and 25 after radiation therapy.
Other Name: Surveys
Experimental: Re-Irradiation Therapy (RRT) to Brain - Adults

Participants may receive up to 6 weeks of radiation therapy. Dose of radiation decided by participant's radiation oncologist.

Quality of life and symptom questionnaires completed at baseline, and at months 1, 3, 5, 7, 9, 11, 13, 16, 19, 22, and 25 after radiation therapy.

 Radiation: Re-Irradiation Therapy (RRT) to Brain
Participants may receive up to 6 weeks of radiation therapy. Dose of radiation decided by participant's radiation oncologist.
Other Name: XRT

Behavioral: Questionnaires
Quality of life and symptom questionnaires completed at baseline, and at months 1, 3, 5, 7, 9, 11, 13, 16, 19, 22, and 25 after radiation therapy.
Other Name: Surveys


Outcome Measures
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Primary Outcome Measures :
  1. Highest Grade of Central Nervous System (CNS) Necrosis [ Time Frame: 6 months ]
    Primary outcome measured as the highest grade of CNS necrosis within 6 months after second course of radiation therapy (RT2). Radiographic evidence of CNS necrosis obtained from advanced brain tumor imaging (ABTI) at every followup and compared to baseline ABTI.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Previous pathologic confirmation of a tumor treated with radiation to the brain completed at least 6 months prior to the start of planned reirradiation, except for patients with tumors that are routinely diagnosed without biopsy, including germinoma and optic pathway glioma. Patients with a history of cranial irradiation for leukemia are eligible.
  2. Patient must have received one and only one previous course of radiation to the brain, delivered at 1.5 - 2.5 Gy/fraction, one fraction per day.
  3. Multidisciplinary evaluation of the patient must be performed with a consensus recommendation for reirradiation.
  4. Patient may not receive concurrent chemotherapy with reirradiation, other than temozolomide or bevacizumab given at the discretion of the treating neuro-oncologist.
  5. Patient must have imaging findings within the last 3 months consistent with recurrent disease in the brain. Pathologic diagnosis of recurrence is not required.
  6. Patient may undergo surgical resection prior to reirradiation.
  7. Dose-volume histogram data and cross-sectional imaging from previous radiation must be obtained. Electronic dosimetry records in DICOM format from previous radiation are strongly preferred.
  8. Signed informed consent by patient and/or parents or legal guardian.
  9. Lansky/Karnofsky Performance Status score of 50-100.

Exclusion Criteria:

  1. Patients with recurrent diffuse intrinsic pontine glioma (DIPG)
  2. Pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698254


Contacts
Contact: Susan L. McGovern, MD, PHD 713-563-2300

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: MD Anderson Health Information Specialist    877-632-6789      
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Susan L. McGovern, MD, PHD M.D. Anderson Cancer Center
More Information
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Additional Information:
University of Texas MD Anderson Cancer Center Website  This link exits the ClinicalTrials.gov site

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02698254     History of Changes
Other Study ID Numbers: 2015-0586
NCI-2016-00536 ( Registry Identifier: NCI CTRP )
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018

Keywords provided by M.D. Anderson Cancer Center:
Brain cancer
Recurrent brain tumor
Prior radiation treatment to brain
Radiation therapy
 XRT
Questionnaires
Surveys

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
 Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases