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A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma

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ClinicalTrials.gov Identifier: NCT02805179
Recruitment Status : Active, not recruiting
First Posted : June 17, 2016
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Study Description
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Brief Summary:
This is a study to determine the safety and effectiveness of high-dose radiation therapy (RT) with concurrent temozolomide in patients with newly diagnosed glioblastoma.

Condition or disease Intervention/treatment Phase
Glioma Radiation: High Dose Radiation Drug: Temozolomide Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of High Dose Radiotherapy and Concurrent Temozolomide Using Biologically-Based Target Volume Definition in Patients With Newly Diagnosed Glioblastoma
Actual Study Start Date : September 22, 2016
Actual Primary Completion Date : February 6, 2020
Estimated Study Completion Date : February 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: High Dose Chemoradiation
Patients will receive high dose radiation based in part on advanced imaging, and concurrent temozolomide. Four weeks after the completion of chemoradiation, patients will receive adjuvant temozolomide.
 Radiation: High Dose Radiation
Radiation will be delivered once daily for a total of 30 fractions, five days per week.

Drug: Temozolomide
Patients will receive concurrent temozolomide (75 mg/m^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival at 12 months [ Time Frame: 12 months after completion of chemoradiation ]
    Number of patients alive at 12 months after completion of chemoradiation


Secondary Outcome Measures :
  1. Number of patients alive without progression at 12 months [ Time Frame: 12 months after completion of chemoradiation ]
    Time from study enrollment until disease progression per standard response assessment in neuro-oncology (RANO) criteria or death from any cause, up to 12 months after completion of chemoradiation.

  2. Average change in tumor volume from baseline to mid-treatment (Week 4) [ Time Frame: Baseline to Week 4 ]
    Tumor volume will be measured by diffusion MRI before treatment start and at mid-treatment. The difference in tumor volume (Week-4 volume minus Week-0 volume) for each patient will be determined and then averaged.

  3. Progression Free Survival [ Time Frame: Up to 2 years after completion of chemoradiation ]
    Number of patients alive without progression at 2 years after completion of chemoradiation.

  4. Overall Survival at 2 years [ Time Frame: At 2 years after completion of chemoradiation ]
    Number of patients alive at 2 years after completion of chemoradiation.


Eligibility Criteria
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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:

  • Newly diagnosed histologically-confirmed supratentorial World Health Organization (WHO) grade IV gliomas including glioblastoma multiforme and gliosarcoma
  • Age 18 or older
  • Karnofsky performance status (a measure to quantify general well being and activities of daily life; scale ranges from 0 to 100 where 100 is perfect health) of greater than or equal to 70
  • Life expectancy of at least 12 weeks
  • Adequate bone marrow reserve (hemoglobin greater than or equal to 10, absolute neutrophil count greater than or equal to 1500, platelets greater than or equal to 100,000); acceptable liver function (total bilirubin less than or equal to 2.0 mg/dl, ALT (Alanine Aminotransferase)/AST (Aspartate Aminotransferase) less than or equal to 5 times the normal range); acceptable renal function (serum creatinine less than or equal to 2.0 mg/dl). Eligibility level for hemoglobin may be reached by transfusion.
  • Maximal contiguous volume of tumor based on high b-value diffusion MRI < 1/3 volume of brain
  • Patients must be registered within 6 weeks of most recent resection.
  • Patients must have signed a study-specific informed consent.

Exclusion Criteria:

  • Recurrent glioma, or tumor involving the brainstem or cerebellum. Prior low-grade glioma without prior RT, now with malignant progression are eligible.
  • Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment is not permitted. Prior chemotherapy for a different cancer is allowable, except for Temozolomide or Bevacizumab.
  • Evidence of cerebrospinal fluid dissemination (positive cerebrospinal fluid cytology for malignancy or MRI findings consistent with CSF dissemination)
  • Evidence of severe concurrent disease requiring treatment
  • Prior invasive malignancy (except non-melanoma skin cancer) unless disease-free for a minimum of 3 years (for example, carcinoma in situ of breast, oral cavity or cervix are all permissible)
  • Patients unable to undergo Magnetic Resonance Imaging exams (MRI) (i.e. patients with non-compatible devices such as cardiac pacemakers, other implanted electronic devices, metallic prostheses, or ferromagnetic prostheses (e.g. pins in artificial joints and surgical pins/clips) or unable to receive gadolinium for MRI, as per the standard UM Department of Radiology MRI screening criteria)
  • Patients treated with previous cranial or head/neck radiotherapy leading to radiation field overlap
  • Females of child-bearing potential must have a negative pregnancy test within 14 days prior to registration. Patients with reproductive potential must agree to use an effective contraceptive method during treatment.
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): NCT02805179


Locations
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United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Investigators
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Principal Investigator: Michelle Kim, M.D. University of Michigan Rogel Cancer Center
More Information
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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT02805179    
Other Study ID Numbers: UMCC 2012.006
HUM00113549 ( Other Identifier: University of Michigan )
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
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
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents