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Mathematical Model-Adapted Radiation In Glioblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03557372
Recruitment Status : Active, not recruiting
First Posted : June 15, 2018
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Shyam Tanguturi, MD, Dana-Farber Cancer Institute

Brief Summary:

This research study is studying a new schedule of radiation therapy for recurrent glioblastoma as a possible treatment for this diagnosis. This radiation schedule is based on a new model for radiation resistance in glioblastoma.

The name of the radiation schedule involved in this study is:

- Re-irradiation for glioblastoma using a novel Mathematical Model-Adapted Radiation Fractionation Schedule


Condition or disease Intervention/treatment Phase
Recurrent Glioblastoma Radiation: Mathematical Model-Adapted Radiation Fractionation Schedule Not Applicable

Detailed Description:

This research study is a Feasibility Study, which means that this is the first time that investigators are examining this new radiation schedule for recurrent glioblastoma.

  • The FDA (the U.S. Food and Drug Administration) has approved radiation therapy as a treatment option for your disease.
  • This is the first time that this particular radiation schedule will be tested in humans. There many other studies which have tested different radiation schedules in glioblastoma.

In this research study, investigators are adapting a standard two-week schedule of radiation commonly used for recurrent glioblastoma using a mathematical model. This study uses the same total dose of radiation as standard treatments but breaks up the dose into different amounts daily to maximize tumor kill. investigators have used a new mathematical model to create this schedule of radiation. This model was created to better represent how glioblastoma cells can escape the damaging effects of radiation. Based on the results of several laboratory studies, it is possible that this model may result in improved outcomes compared to standard radiation schedules.

The primary question of this study is to see whether participants can complete this new radiation schedule at the scheduled times. In addition, investigators will follow participants to ensure that this treatment is safe. If this treatment proves feasible, investigators hope to compare this treatment directly with standard radiation schedules for newly diagnosed and recurrent glioblastoma.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mathematical Model-Adapted Radiation Fractionation Schedule for Patients With Recurrent Glioblastoma (MARS-Glio)
Actual Study Start Date : November 12, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mathematical Model-Adapted Radiation
Mathematical Model-Adapted Radiation Fractionation Schedule
Radiation: Mathematical Model-Adapted Radiation Fractionation Schedule
  • Re-irradiation with 35 Gy delivered over 2 weeks, based upon reference dosing of 35 Gy in 10 Fractions over 2 weeks
  • Radiation therapy is delivered on Monday-Friday during standard clinic hours in our department. Each treatment may take 20-40 minutes.
  • Treatment will be once daily for the first 7 days of treatment and then three-times daily for the last three days of treatment.




Primary Outcome Measures :
  1. Number of Participants to complete Model Adapted Radiations Fractionation scheduled [ Time Frame: 10 Days ]
    Feasibility is defined as successful completion of radiation therapy for at least 13 of 14 patients. Successful completion of radiotherapy is defined as receipt of all scheduled fractions of daily radiotherapy within 24 hours of once daily fractions and within 1 hour of three-times daily fractions.


Secondary Outcome Measures :
  1. Quality of Life (MD Anderson Symptom Inventory Brain Tumor) [ Time Frame: Baseline and 4 weeks after Completion of Reirradiation ]
    MDASI-BT index. 22 questions about different symptoms rated on a scale from 1 to 10, 1 being "not present" and 10 being "as bad as you can imagine," plus 5 questions about the impact of symptoms on quality of life on a scale from 1 to 10, 1 being "doesn't interfere" and 10 being "completely interferes." Subscales are not combined.

  2. Quality of Life (MD Anderson Symptom Inventory Brain Tumor) [ Time Frame: 6 months ]
    MDASI-BT index. 22 questions about different symptoms rated on a scale from 1 to 10, 1 being "not present" and 10 being "as bad as you can imagine," plus 5 questions about the impact of symptoms on quality of life on a scale from 1 to 10, 1 being "doesn't interfere" and 10 being "completely interferes." Subscales are not combined.

  3. Incidence of radiation necrosis [ Time Frame: 6 months ]
    Kaplan-Meier plot, Cox regression

  4. Time to development of radiation necrosis [ Time Frame: 6 months ]
    Kaplan-Meier plot, Cox regression

  5. Incidence of seizures [ Time Frame: 6 months ]
    Kaplan-Meier plot, Cox regression

  6. Time to the development of seizures [ Time Frame: 6 months ]
    Kaplan-Meier plot, Cox regression

  7. Overall Survival [ Time Frame: 6 months ]
    Kaplan-Meier plot, Cox regression

  8. Karnofsky Performance Status [ Time Frame: 6 months ]
    Longitudinal regression

  9. Incidence of Grade 3+ Acute or Delayed CNS toxicity [ Time Frame: 6 Months ]
    CTCAEv5.0; Exact binomial distribution with 95% confidence intervals

  10. Time to the development of Grade 3+ acute or delayed CNS toxicity [ Time Frame: 6 Months ]
    CTCAEv5.0

  11. Progression-free survival [ Time Frame: 6 Months ]
    Kaplan-Meier plot, Cox regression

  12. Local recurrence [ Time Frame: 6 Months ]
    Kaplan-Meier plot

  13. Incidence of salvage craniotomy [ Time Frame: 6 Months ]
    Kaplan-Meier plot, Cox regression

  14. Time to salvage craniotomy [ Time Frame: 6 Months ]
    Kaplan-Meier plot, Cox regression

  15. Incidence of additional systemic treatments after reirradiation [ Time Frame: 6 Months ]
    Kaplan-Meier plot, Cox regression

  16. Time to additional systemic treatments after reirradiation [ Time Frame: 6 Months ]
    Kaplan-Meier plot, Cox regression

  17. Tumor Volumes [ Time Frame: 6 Months ]
    Based on the intended radiation administration times and actual radiation administration times) will be compared to the measured tumor volumes obtained from the MRI data that will be collected for the RANO response criteria using residual sum of squares



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have recurrent glioblastoma (WHO Grade IV), as defined on brain imaging with CT or MRI, after prior receipt of definitive therapy including neurosurgical biopsy or resection and radiation therapy with or without systemic therapy.
  • Participants must be deemed appropriate candidates for re-irradiation
  • Histopathologic confirmation of disease as part of routine clinical care is required either at the time of initial diagnosis and/or at the time of recurrent disease. There is no requirement for central pathologic review.
  • Age ≥ 18 years at the time of enrollment
  • Karnofsky Performance Status (KPS) of at least 70
  • Exclusion Criteria
  • Participants who have received more than one prior course of radiotherapy to the local site of progressive disease
  • Participants who have received prior radiotherapy to the local site of progressive disease within < 3 months of the anticipated start of re-irradiation
  • Participants with recurrent tumor extensively abutting or involving the optic structures or brainstem, as assessed by the treating radiation oncologist
  • Participants without a definable tumor cavity on MRI or CT obtained at study enrollment
  • Participants receiving concurrent cytotoxic chemotherapy (i.e. temozolomide, CCNU, vincristine, procarbazine) or concurrent immunotherapy (i.e. pembrolizumab, nivolumab); however, participants may receive sequential chemotherapy before or after radiation without limitation. Participants may receive concurrent corticosteroid and/or anti-angiogenic therapy (i.e. bevacizumab) if clinically indicated.

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): NCT03557372


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Shyam Tanguturi, MD Brigham and Women's Hospital

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Responsible Party: Shyam Tanguturi, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03557372    
Other Study ID Numbers: 18-105
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Shyam Tanguturi, MD, Dana-Farber Cancer Institute:
Recurrent glioblastoma
Radiation Therapy
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue