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Biologically-based Target Volumes to Treat Newly Diagnosed Glioblastoma

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ClinicalTrials.gov Identifier: NCT03506139
Recruitment Status : Not yet recruiting
First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Collaborator:
Holden Comprehensive Cancer Center
Information provided by (Responsible Party):
John M. Buatti, University of Iowa

Brief Summary:
This clinical trial increases radiation to areas of the brain considered to be at risk for cancer. The at-risk areas are identified by a biological MRI scan. The study will look at side effects of the radiation and overall survival.

Condition or disease Intervention/treatment Phase
Glioblastoma Glioblastoma Multiforme Radiation: External beam radiation therapy Phase 2

Detailed Description:

This study evaluates if increasing radiation dose to at-risk areas impacts overall survival without causing a decrease in quality of life or an increase in radiation side effects.

Standard radiation dose for glioblastoma (GBM) is 60 Gray in 30 fractions, with patients receiving 1 fraction per day, Monday through Friday.

This trial will use a total of 75 Gray in 30 fractions, with participants receiving 1 fraction per day, Monday through Friday. Participants will still receive the standard chemotherapy (temozolomide) at the standard dose (75 mg/m2, once daily, 7 days a week).

This study also uses a different imaging technique to identify the tumor target and the tissues at risk. Normal imaging techniques will be used to define the standard target volume and will receive the standard radiation dose (60 Gray). A special MRI sequence will identify at risk areas based on diffusion and perfusion abnormalities. This area will receive the higher radiation dose (75 Gray).

Participants will also be asked to complete quality of life questionnaires and neurocognitive evaluations at specific time points. This is to identify any side effects from the higher radiation dose. Preliminary work done at University of Michigan suggests a lack of side effects from the higher dose of radiation.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Group treated to 75 Gray of radiation to at-risk target
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
Estimated Study Start Date : April 30, 2018
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Radiation Therapy
External beam radiation therapy delivered to target volume.
Radiation: External beam radiation therapy
Radiotherapy to 75 Gy Radiation delivered 1 fraction / day, Monday through Friday, for a total of 30 fractions
Other Names:
  • radiotherapy
  • radiation



Primary Outcome Measures :
  1. Overall survival [ Time Frame: 12 months after completing radiation therapy ]
    Estimate 12-month overall survival of GBM patients treated with 75 Gray of radiation based on advanced MRI planning, with concurrent temozolomide.


Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: Every 2 months, for up to 60 months after completing radiation therapy, until progression or death from any cause ]
    Estimate progression-free survival (PFS) in GBM patients treated with 75 Gray of radiation based on advanced MRI planning, with concurrent temozolomide.

  2. Identifying tissue at risk of recurrence [ Time Frame: 12 months after completing radiation therapy ]
    Assess the ability of pre-treatment and mid-treatment advanced MRI to determine areas at high risk of recurrence

  3. Distinguish progression from pseudoprogression [ Time Frame: 12 months after completing radiation therapy ]
    Assess the ability of post-treatment advanced MRI to distinguish progression from pseudoprogression

  4. Adverse events related to treatment [ Time Frame: Weekly during radiation therapy, every 2 months post-radiation therapy for 7 months, then 13 & 19 months post-radiation ]
    Provide descriptive data regarding health-related quality of life (QOL), symptoms and neurocognitive function



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

Inclusion Criteria:

  • Ability to understand and willingness to provide informed consent
  • Newly diagnosed, histologically-confirmed supratentorial WHO grade IV gliomas including glioblastoma (all variants) and gliosarcoma.
  • Patients must be 18 years of age or older.≥
  • Karnofsky performance status ≥ 70
  • Minimal life expectancy of 12 weeks.
  • Maximal contiguous volume of tumor based on high b-value diffusion MRI and perfusion MRI < 1/3 volume of brain
  • Patients must be treated within 6 weeks of most recent resection

Within 21 days of radiation fraction 1, the following blood test parameters must be met:

  • Hemoglobin ≥ 10 g/dL (transfusion is acceptable)
  • absolute neutrophils ≥ 1500/mm3
  • platelet count ≥ 100,000/mm3
  • total bilirubin ≤ 2 x upper limit of normal (ULN) (unless elevated bilirubin is related to Gilbert syndrome)
  • ALT and AST ≤ 5 x ULN
  • serum creatinine ≤ 2.0 mg/dL

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 if interval since last treatment cycle completion is >3 years.
  • Evidence of CSF dissemination (positive CSF cytology for malignancy or MRI findings consistent with CSF dissemination).
  • Multifocal disease (>1 lobe of involvement) of discontiguous, contrast enhancing disease as seen on conventional MRI
  • Evidence of severe concurrent disease requiring treatment
  • Known active malignancy as determined by treating medical and radiation oncologist
  • Patients unable to undergo MRI exams
  • Patients treated with previous cranial or head/neck radiotherapy leading to significant radiation field overlap.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring inpatient hospitalization or delay treatment, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or compromise subject safety.
  • Pregnant women are excluded from this study because ionizing radiation is a known teratogen, and temozolomide is a Class D agent with the potential for teratogenic or abortifacient effects.
  • Nursing mothers declining to discontinue breastfeeding are excluded because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with temozolomide.
  • Patients with reproductive potential declining to use an effective contraceptive method during treatment are excluded from this study.

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): NCT03506139


Contacts
Contact: Heather Brown, RN, BAN (319) 384-7912 heather-brown@uiowa.edu
Contact: Sandy Vollstedt, RN, BSN (319) 353-7143 sandy-vollstedt@uiowa.edu

Sponsors and Collaborators
John M. Buatti
Holden Comprehensive Cancer Center
Investigators
Principal Investigator: John M. Buatti, MD The University of Iowa

Publications:
Responsible Party: John M. Buatti, Professor & Chair, Department of Radiation Oncology, University of Iowa
ClinicalTrials.gov Identifier: NCT03506139     History of Changes
Other Study ID Numbers: 201801819
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified Individual participant data will be shared with a signed usage agreement. Additionally, a contract will be required between University of Iowa and the receiving institution.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Upon request
Access Criteria: Email study contacts with request
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by John M. Buatti, University of Iowa:
Radiotherapy
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue