Spectroscopic MRI-Guided Radiation Therapy Planning in Glioblastoma
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|ClinicalTrials.gov Identifier: NCT03137888|
Recruitment Status : Active, not recruiting
First Posted : May 3, 2017
Last Update Posted : July 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Gliosarcoma||Radiation: Dose-Escalated Radiation Therapy Procedure: Spectroscopic Magnetic Resonance Imaging Drug: Temozolomide||Phase 2|
I. To determine the feasibility of using spectroscopic MRI (sMRI) to guide dose-escalated radiation therapy (RT) for newly-diagnosed glioblastoma (GBM)s.
II. To determine the safety of using sMRI to guide dose-escalated RT for newly-diagnosed GBMs.
I. To determine whether the progression free survival at 1 year with sMRI-guided, dose-escalated RT is improved for newly-diagnosed GBMs.
I. To determine whether sMRI-guided, dose-escalated RT increases the overall survival of patients with newly diagnosed GBMs.
II. To determine whether sMRI data obtained after initiation of therapy (at 2 weeks after RT/TMZ start and prior to cycle 1 and 5 of adjuvant temozolomide [TMZ]) will provide early evidence of GBM progression not seen on standard MRIs.
III. To determine whether performance on neurocognitive and quality-of-life (QOL) assessments in newly-diagnosed GBM patients treated with sMRI-guided, dose-escalated RT differ from historical controls.
Patients undergo sMRI-guided radiation therapy daily for the first 5 days of every week (Monday - Friday) over 6 weeks. Patients also receive standard of care temozolomide orally (PO) daily during radiation therapy for up to 42 days.
After completion of study treatment, patients are followed up every 3 months for up to 2 years and then periodically.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Spectroscopic MRI-Guided, Dose-Escalated Radiation Therapy for Newly-Diagnosed Glioblastoma|
|Actual Study Start Date :||September 20, 2017|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
Experimental: sMRI-Guided RT with TMZ
Patients undergo spectroscopic magnetic resonance imaging-guided dose-escalated radiation therapy daily for the first 5 days of every week (Monday - Friday) over 6 weeks. Patients also receive standard of care temozolomide PO daily during radiation therapy for up to 42 days.
Radiation: Dose-Escalated Radiation Therapy
Undergo sMRI-guided radiation therapy, dose painted to maximum of 75 Gy over six weeks
Procedure: Spectroscopic Magnetic Resonance Imaging
Patients will undergo sMRI scans within a 14 day window prior to starting treatment
- Feasibility as assessed by successful co-registration of sMRI-based treatment volumes with clinical images into the radiation treatment execution platform [ Time Frame: Up to 2 years after completion of therapy ]Feasibility of this approach will be determined by whether treatment volumes based on sMRI can be co-registered with clinical images and transferred into the radiation treatment execution platform in a seamless manner, so that sMRI information can be efficiently applied to the patient treatment.
- Incidence of adverse event assessed by Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 2 years after completion of therapy ]The safety of sMRI to guide dose-escalated RT will be confirmed by assessing toxicity potentially attributable to the RT.
- Progression free survival (PFS) [ Time Frame: From the time of surgical resection to the time of either radiographic progression or death, whichever occurs first, assessed at 1 year ]PFS actuarial curves will be assessed and compared to historical controls, and will particularly interested in comparing the 1-year PFS rate which, based on the control arm (receiving standard dose RT with TMZ) of recent GBM trials, is approximately 30% in historical cohorts.
- Early evidence of GBM progression assessed by sMRI [ Time Frame: At 2 weeks after start of therapy ]Changes in sMRI parameters over time will be assessed to determine whether they will be able to predict development of recurrence.
- Neurocognitive performance: Hopkins Verbal Learning Test [ Time Frame: Up to 2 years after completion of therapy ]Neurocognitive performance will be assessed by the Hopkins Verbal Learning Test - Revised.
- Neurocognitive performance: Controlled Oral Word Association Test [ Time Frame: Up to 2 years after completion of therapy ]Neurocognitive performance will be assessed by the Controlled Oral Word Association Test (COWAT) from the Multilingual Aphasia Examination.
- Overall survival (OS) [ Time Frame: From the time of surgical resection to the time of death, assessed up to 1 year ]The OS actuarial curve and 1-year OS rate will be assessed and compared to historical controls.
- Quality of life (QOL): European Organization for Research and Treatment of Cancer [ Time Frame: Up to 2 years after completion of therapy ]QOL will be assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30/Brain Cancer Module-20.
- Quality of life (QOL): MD Anderson [ Time Frame: Up to 2 years after completion of therapy ]QOL will be assessed by the MD Anderson Symptom Inventory Brain Tumor Module.
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): NCT03137888
|United States, Florida|
|University of Miami Miller School of Medicine-Sylvester Cancer Center|
|Miami, Florida, United States, 33136|
|United States, Georgia|
|Emory University/Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|United States, Maryland|
|Johns Hopkins University/Sidney Kimmel Cancer Center|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Hui-Kuo Shu, MD, PhD||Emory University/Winship Cancer Institute|