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Biologically-based Target Volumes to Treat Newly Diagnosed Glioblastoma

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ClinicalTrials.gov Identifier: NCT03506139
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
Holden Comprehensive Cancer Center
Information provided by (Responsible Party):
John M. Buatti, University of Iowa

Tracking Information
First Submitted Date  ICMJE April 12, 2018
First Posted Date  ICMJE April 23, 2018
Last Update Posted Date July 24, 2019
Actual Study Start Date  ICMJE May 15, 2019
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03506139 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
  • 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.
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biologically-based Target Volumes to Treat Newly Diagnosed Glioblastoma
Official Title  ICMJE Phase II Study of High Dose Radiotherapy and Concurrent Temozolomide Using Biologically-based Target Volume Definition in Patients With Newly Diagnosed Glioblastoma
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Glioblastoma
  • Glioblastoma Multiforme
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Radiation Therapy
External beam radiation therapy delivered to target volume.
Intervention: Radiation: External beam radiation therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 20, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2026
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Heather Brown, RN, BAN (319) 384-7912 heather-brown@uiowa.edu
Contact: Sandy Vollstedt, RN, BSN (319) 353-7143 sandy-vollstedt@uiowa.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03506139
Other Study ID Numbers  ICMJE 201801819
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Upon request
Access Criteria: Email study contacts with request
Responsible Party John M. Buatti, University of Iowa
Study Sponsor  ICMJE John M. Buatti
Collaborators  ICMJE Holden Comprehensive Cancer Center
Investigators  ICMJE
Principal Investigator: John M. Buatti, MD University of Iowa
PRS Account University of Iowa
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP