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MRI Scans in Evaluating the Effects of Radiation Therapy and Chemotherapy in Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Glioma

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ClinicalTrials.gov Identifier: NCT00756106
Recruitment Status : Terminated (Funding ended)
First Posted : September 19, 2008
Results First Posted : April 21, 2020
Last Update Posted : May 13, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Elizabeth R. Gerstner, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Brain and Central Nervous System Tumors
Interventions Drug: temozolomide
Other: Imaging biomarker analysis
Radiation: Photon Radiation Therapy
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Temozolomide and Radiation Therapy
Hide Arm/Group Description

temozolomide: Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator.

Imaging biomarker analysis: MRI

Photon Radiation Therapy: Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions.

Period Title: Overall Study
Started 15
Completed 3
Not Completed 12
Arm/Group Title Temozolomide and Radiation Therapy
Hide Arm/Group Description

temozolomide: Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator.

Imaging biomarker analysis: MRI

Photon Radiation Therapy: Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions.

Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
One participant withdrew consent after baseline and was excluded from the analysis set
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 14 participants
60
(35 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
8
  57.1%
Male
6
  42.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
Karnofsky Performance Status   [1] 
Median (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 14 participants
90
(60 to 100)
[1]
Measure Description: The Karnofsky Performance Status is a measure of patients' general well-being and activities of daily living. The score ranges from 0 to 100, higher scores indicating a patient is better able to carry out daily activities.
1.Primary Outcome
Title Relative Cerebral Blood Volume as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy
Hide Description

Relative cerebral blood volume (rCBV) is the blood volume in the region of interest (ROI) divided by the blood volume in the symmetrical region on the other side of the normal brain (control region). CBV was assessed using spin-echo post-contrast T1-weighted images. Multiple images were used to assess each participant at every time-point and the median value for each participant was calculated by time-point. The data presented represent the average of those median values at each time-point. The baseline value was measured twice (representing baseline 1 and 2) to make sure that the value was reproducible and to account for any variation attributable to measurement variation.

CRT: Chemoradiotherapy Cx: The cycle number TMZ: temozolomide

Time Frame Baseline, weekly during treatment, monthly following treatment for up to six months
Hide Outcome Measure Data
Hide Analysis Population Description
One participant withdrew consent after baseline and was excluded from the analysis set. The number of patients evaluated decreased over time due to participants experiencing disease progression and discontinuing from the study
Arm/Group Title Temozolomide and Radiation Therapy
Hide Arm/Group Description:

temozolomide: Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator.

Imaging biomarker analysis: MRI

Photon Radiation Therapy: Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions.

Overall Number of Participants Analyzed 14
Mean (Full Range)
Unit of Measure: ratio
Baseline 1 Number Analyzed 14 participants
0.88
(0.50 to 1.47)
Baseline 2 Number Analyzed 14 participants
0.90
(0.36 to 1.77)
Week 1 CRT Number Analyzed 14 participants
0.95
(0.47 to 1.78)
Week 2 CRT Number Analyzed 14 participants
1.0
(0.63 to 1.68)
Week 3 CRT Number Analyzed 14 participants
0.88
(0.39 to 1.58)
Week 4 CRT Number Analyzed 14 participants
0.83
(0.43 to 1.24)
Week 5 CRT Number Analyzed 14 participants
0.86
(0.43 to 1.33)
Week 6 CRT Number Analyzed 14 participants
0.76
(0.41 to 1.21)
Pre-C1 TMZ Number Analyzed 14 participants
0.68
(0.48 to 1.04)
Pre-C2 TMZ Number Analyzed 9 participants
0.61
(0.45 to 0.83)
Pre-C3 TMZ Number Analyzed 8 participants
0.59
(0.37 to 0.82)
Pre-C4 TMZ Number Analyzed 6 participants
0.65
(0.38 to 0.87)
Pre-C5 TMZ Number Analyzed 5 participants
0.61
(0.39 to 0.8)
Pre-C6 TMZ Number Analyzed 4 participants
0.64
(0.18 to 1.30)
Post-TMZ Number Analyzed 3 participants
0.32
(0.09 to 0.56)
2.Primary Outcome
Title Relative Cerebral Blood Flow as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy
Hide Description

Relative cerebral blood flow (rCBF) is the blood flow rate (the volume of blood passing through the specified are over a specified period of time) in the region of interest (ROI) divided by the blood flow rate in the symmetrical region on the other side of the normal brain (control region). CBF was assessed using spin-echo post-contrast T1-weighted images. CBF was assessed using spin-echo post-contrast T1-weighted images. Multiple images were used to assess each participant at every time-point and the median value for each participant was calculated by time-point. The data presented represent the average of those median values at each time-point. The baseline value was measured twice (representing baseline 1 and 2) to make sure that the value was reproducible and to account for any variation attributable to measurement variation.

CRT: Chemoradiotherapy Cx: The cycle number TMZ: temozolomide

Time Frame Baseline, weekly during treatment, monthly following treatment for up to six months
Hide Outcome Measure Data
Hide Analysis Population Description
One participant withdrew consent after baseline and was excluded from the analysis set. The number of patients evaluated decreased over time due to participants experiencing disease progression and discontinuing from the study
Arm/Group Title Temozolomide and Radiation Therapy
Hide Arm/Group Description:

temozolomide: Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator.

Imaging biomarker analysis: MRI

Photon Radiation Therapy: Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions.

Overall Number of Participants Analyzed 14
Mean (Full Range)
Unit of Measure: ratio
Baseline 1 Number Analyzed 14 participants
0.83
(0.49 to 1.20)
Baseline 2 Number Analyzed 14 participants
0.86
(0.33 to 1.43)
Week 1 CRT Number Analyzed 14 participants
0.92
(0.59 to 1.37)
Week 2 CRT Number Analyzed 14 participants
0.94
(0.63 to 1.51)
Week 3 CRT Number Analyzed 14 participants
0.80
(0.46 to 1.38)
Week 4 CRT Number Analyzed 14 participants
0.79
(0.49 to 1.16)
Week 5 CRT Number Analyzed 14 participants
0.83
(0.48 to 1.30)
Week 6 CRT Number Analyzed 14 participants
0.73
(0.52 to 1.10)
Pre-C1 TMZ Number Analyzed 14 participants
0.63
(0.45 to 0.92)
Pre-C2 TMZ Number Analyzed 9 participants
0.59
(0.5 to 0.69)
Pre-C3 TMZ Number Analyzed 8 participants
0.60
(0.40 to 0.77)
Pre-C4 TMZ Number Analyzed 6 participants
0.60
(0.52 to 0.67)
Pre-C5 TMZ Number Analyzed 5 participants
0.52
(0.33 to 0.70)
Pre-C6 TMZ Number Analyzed 4 participants
0.47
(0.30 to 0.66)
Post-TMZ Number Analyzed 3 participants
0.37
(0.16 to 0.59)
3.Primary Outcome
Title Vessel Diameter as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy
Hide Description [Not Specified]
Time Frame Baseline, weekly during treatment, monthly following treatment for up to six months
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Temozolomide and Radiation Therapy
Hide Arm/Group Description:

temozolomide: Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator.

Imaging biomarker analysis: MRI

Photon Radiation Therapy: Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Primary Outcome
Title Mean Transit Time as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy
Hide Description Mean transit time (MTT) corresponds to the average time, in seconds, that red blood cells spend within a determinate volume of capillary circulation.
Time Frame Baseline, weekly during treatment, monthly following treatment for up to six months
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Temozolomide and Radiation Therapy
Hide Arm/Group Description:

temozolomide: Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator.

Imaging biomarker analysis: MRI

Photon Radiation Therapy: Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Primary Outcome
Title Permeability-surface Area Product Before, During, and After Chemoradiotherapy
Hide Description

Permeability-surface Area Product (Ktrans). Ktrans reflects the efflux rate of contrast from blood plasma into the tissue extravascular extracellular space (EES). Ktrans was assessed using post-contrast T1-weighted images. Multiple images were used to assess each participant at every time-point and the median value for each participant was calculated by time-point. The data presented represent the average of those median values at each time-point.

CRT: Chemoradiotherapy Cx: The cycle number TMZ: temozolomide

Time Frame Baseline, weekly during treatment, monthly following treatment for up to six months
Hide Outcome Measure Data
Hide Analysis Population Description
One participant withdrew consent after baseline and was excluded from the analysis set. The number of patients evaluated decreased over time due to participants experiencing disease progression and discontinuing from the study
Arm/Group Title Temozolomide and Radiation Therapy
Hide Arm/Group Description:

temozolomide: Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator.

Imaging biomarker analysis: MRI

Photon Radiation Therapy: Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions.

Overall Number of Participants Analyzed 14
Mean (Full Range)
Unit of Measure: min ^-1
Baseline 1 Number Analyzed 14 participants
0.053
(0.015 to .138)
Baseline 2 Number Analyzed 14 participants
0.039
(0.012 to 0.075)
Week 1 CRT Number Analyzed 14 participants
0.055
(0.021 to 0.128)
Week 2 CRT Number Analyzed 14 participants
0.048
(0.018 to 0.105)
Week 3 CRT Number Analyzed 14 participants
0.055
(0.014 to 0.100)
Week 4 CRT Number Analyzed 14 participants
0.053
(0.010 to 0.107)
Week 5 CRT Number Analyzed 14 participants
0.058
(0.009 to 0.154)
Week 6 CRT Number Analyzed 14 participants
0.059
(0.016 to 0.127)
Pre-C1 TMZ Number Analyzed 14 participants
0.063
(0.012 to 0.152)
Pre-C2 TMZ Number Analyzed 9 participants
0.042
(0.007 to 0.068)
Pre-C3 TMZ Number Analyzed 8 participants
0.050
(0.025 to 0.106)
Pre-C4 TMZ Number Analyzed 6 participants
0.058
(0.014 to 0.139)
Pre-C5 TMZ Number Analyzed 5 participants
0.056
(0.004 to 0.137)
Pre-C6 TMZ Number Analyzed 4 participants
0.060
(0.008 to 0.121)
Post-TMZ Number Analyzed 3 participants
0.032
(0.010 to 0.054)
6.Primary Outcome
Title Apparent Diffusion Coefficient Before, During, and After Chemoradiotherapy
Hide Description

Apparent diffusion coefficient (ADC) is a measure of the magnitude of diffusion (of water molecules) within tissue. ADC was assessed using post-contrast T1-weighted images. Multiple images were used to assess each participant at every time-point and the median value for each participant was calculated by time-point. The data presented represent the average of those median values at each time-point.

CRT: Chemoradiotherapy Cx: The cycle number TMZ: temozolomide

Time Frame Baseline, weekly during treatment, monthly following treatment for up to six months
Hide Outcome Measure Data
Hide Analysis Population Description
One participant withdrew consent after baseline and was excluded from the analysis set. The number of patients evaluated decreased over time due to participants experiencing disease progression and discontinuing from the study
Arm/Group Title Temozolomide and Radiation Therapy
Hide Arm/Group Description:

temozolomide: Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator.

Imaging biomarker analysis: MRI

Photon Radiation Therapy: Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions.

Overall Number of Participants Analyzed 14
Mean (Full Range)
Unit of Measure: mm2/s
Baseline 1 Number Analyzed 14 participants
0.00110
(0.00078 to 0.00169)
Baseline 2 Number Analyzed 14 participants
0.00113
(0.00078 to 0.00209)
Week 1 CRT Number Analyzed 14 participants
0.00106
(0.00073 to 0.00145)
Week 2 CRT Number Analyzed 14 participants
0.00110
(0.00092 to 0.00136)
Week 3 CRT Number Analyzed 14 participants
0.00118
(0.00090 to 0.00156)
Week 4 CRT Number Analyzed 14 participants
0.00122
(0.00097 to 0.00154)
Week 5 CRT Number Analyzed 14 participants
0.00125
(0.00103 to 0.00158)
Week 6 CRT Number Analyzed 14 participants
0.00125
(0.00098 to 0.00154)
Pre-C1 TMZ Number Analyzed 14 participants
0.00132
(0.00107 to 0.00173)
Pre-C2 TMZ Number Analyzed 9 participants
0.00127
(0.00101 to 0.00155)
Pre-C3 TMZ Number Analyzed 8 participants
0.00108
(0.00043 to 0.00128)
Pre-C4 TMZ Number Analyzed 6 participants
0.00133
(0.00112 to 0.00151)
Pre-C5 TMZ Number Analyzed 5 participants
0.00148
(0.00069 to 0.00257)
Pre-C6 TMZ Number Analyzed 4 participants
0.00179
(0.00140 to 0.00258)
Post-TMZ Number Analyzed 3 participants
0.00140
(0.00005 to 0.00275)
7.Primary Outcome
Title Tensor Fractional Anisotropy Before, During, and After Chemoradiotherapy
Hide Description Fractional anisotropy (FA) is a measure of the directionality of the molecular motion of water.
Time Frame Baseline, weekly during treatment, monthly following treatment for up to six months
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Temozolomide and Radiation Therapy
Hide Arm/Group Description:

temozolomide: Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator.

Imaging biomarker analysis: MRI

Photon Radiation Therapy: Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Primary Outcome
Title Relative Regional Concentrations of Choline, N-acetyl-asparate, and Myoinositol as Measured by Magnetic Resonance Spectroscopy Before, During, and After Chemoradiotherapy to Interrogate Cell Membrane Turnover, Neuronal Integrity, and Glial Reactions
Hide Description [Not Specified]
Time Frame Baseline, weekly during treatment, monthly following treatment for up to six months
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Temozolomide and Radiation Therapy
Hide Arm/Group Description:

temozolomide: Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator.

Imaging biomarker analysis: MRI

Photon Radiation Therapy: Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Primary Outcome
Title Affects of a Short Period of 100% Oxygen Inhalation on Imaging of Tumor and Surrounding Tissue Regions of Interest, Specifically Cerebral Blood Volume Changes in Each Area as Compared to Room Air
Hide Description [Not Specified]
Time Frame Baseline, weekly during treatment, monthly following treatment for up to six months
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Temozolomide and Radiation Therapy
Hide Arm/Group Description:

temozolomide: Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator.

Imaging biomarker analysis: MRI

Photon Radiation Therapy: Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data were not collected
Adverse Event Reporting Description Adverse event data were not collected as a part of this study
 
Arm/Group Title Temozolomide and Radiation Therapy
Hide Arm/Group Description

temozolomide: Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator.

Imaging biomarker analysis: MRI

Photon Radiation Therapy: Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions.

All-Cause Mortality
Temozolomide and Radiation Therapy
Affected / at Risk (%)
Total   0/0 
Hide Serious Adverse Events
Temozolomide and Radiation Therapy
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Temozolomide and Radiation Therapy
Affected / at Risk (%)
Total   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Elizabeth Gerstner
Organization: Massachusetts General Hospital
EMail: EGERSTNER@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Elizabeth R. Gerstner, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00756106    
Other Study ID Numbers: 07-292
First Submitted: September 18, 2008
First Posted: September 19, 2008
Results First Submitted: March 23, 2020
Results First Posted: April 21, 2020
Last Update Posted: May 13, 2020