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Dose Escalated MRSI Guided Radiation Therapy in Glioblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02394665
Recruitment Status : Terminated (Lack of Accrual/Enrollment)
First Posted : March 20, 2015
Results First Posted : January 5, 2017
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
University of Miami

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Glioblastoma
Interventions Radiation: Intensity Modulated Radiation Therapy
Drug: Temozolomide
Behavioral: Functional Assessment of Cancer Therapy-Brain (FACT-Br)
Radiation: Stereotactic Radiosurgery Boost
Radiation: Simultaneous Integrated Boost
Device: 3D MRSI
Enrollment 1
Recruitment Details  
Pre-assignment Details Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.
Arm/Group Title No Treatment Group Assigned Group 1: SIB + IMRT Group 2: SRS Boost + IMRT
Hide Arm/Group Description For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
  • Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;
  • 3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
  • Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
  • Adjuvant Temozolomide Therapy for up to 12 cycles.

For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:

  • Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;
  • 3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
  • Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
  • Adjuvant Temozolomide Therapy for up to 12 cycles.
Period Title: Overall Study
Started 1 0 0
Completed 0 0 0
Not Completed 1 0 0
Reason Not Completed
Physician Decision             1             0             0
Arm/Group Title No Treatment Group Assigned Group 1: SIB + IMRT Group 2: SRS Boost + IMRT Total
Hide Arm/Group Description For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
  • Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;
  • 3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
  • Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
  • Adjuvant Temozolomide Therapy for up to 12 cycles.

For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:

  • Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;
  • 3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
  • Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
  • Adjuvant Temozolomide Therapy for up to 12 cycles.
Total of all reporting groups
Overall Number of Baseline Participants 1 0 0 1
Hide Baseline Analysis Population Description
Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 0 participants 1 participants
<=18 years
0
   0.0%
0 0
0
   0.0%
Between 18 and 65 years
0
   0.0%
0 0
0
   0.0%
>=65 years
1
 100.0%
0 0
1
 100.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 0 participants 1 participants
Female
0
   0.0%
0 0
0
   0.0%
Male
1
 100.0%
0 0
1
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 0 participants 0 participants 1 participants
1 1
1.Primary Outcome
Title Rate of Overall Survival (OS) in Study Patients
Hide Description The efficacy of 3D MRSI-guided, dose escalated radiation in newly diagnosed glioblastoma (GBM) patients as measured by overall survival (OS). Overall survival (OS) is defined as the time elapsed from the start of study treatment until death. Surviving patients (including patients lost to follow up) will be censored at the date of last contact.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.
Arm/Group Title No Treatment Group Assigned Group 1: SIB + IMRT Group 2: SRS Boost + IMRT
Hide Arm/Group Description:
For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
  • Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;
  • 3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
  • Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
  • Adjuvant Temozolomide Therapy for up to 12 cycles.

For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:

  • Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;
  • 3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
  • Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
  • Adjuvant Temozolomide Therapy for up to 12 cycles.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Rate of Progression-Free Survival (PFS) in Study Patients
Hide Description Rate of progression-free survival in study participants. Progression-free survival (PFS) is defined as the time elapsed from the start of study treatment to the date of documented progression events. For progression-free patients (without progression events), PFS will be censored at the last date of documented PF status.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.
Arm/Group Title No Treatment Group Assigned Group 1: SIB + IMRT Group 2: SRS Boost + IMRT
Hide Arm/Group Description:
For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
  • Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;
  • 3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
  • Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
  • Adjuvant Temozolomide Therapy for up to 12 cycles.

For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:

  • Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;
  • 3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
  • Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
  • Adjuvant Temozolomide Therapy for up to 12 cycles.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Rate of Grade 3 or Higher Toxicity as a a Consequence of Study Therapy.
Hide Description Rate of Grade 3 of Higher Toxicity in study participants as a consequence of study therapy.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.
Arm/Group Title No Treatment Group Assigned Group 1: SIB + IMRT Group 2: SRS Boost + IMRT
Hide Arm/Group Description:
For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
  • Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;
  • 3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
  • Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
  • Adjuvant Temozolomide Therapy for up to 12 cycles.

For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:

  • Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;
  • 3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
  • Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
  • Adjuvant Temozolomide Therapy for up to 12 cycles.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change in Quality of Life From Baseline in Study Participants
Hide Description Change in quality of life during radiation and across the longitudinal progression-free interval compared to baseline. Change of quality of life will be assessed and scored via the FACT-Br behavioral questionnaire.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.
Arm/Group Title No Treatment Group Assigned Group 1: SIB + IMRT Group 2: SRS Boost + IMRT
Hide Arm/Group Description:
For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
  • Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;
  • 3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
  • Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
  • Adjuvant Temozolomide Therapy for up to 12 cycles.

For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:

  • Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;
  • 3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
  • Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
  • Adjuvant Temozolomide Therapy for up to 12 cycles.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Patterns of Failure in Study Participants Post-Protocol Therapy
Hide Description Patterns of Failure will be assessed by determining the number of failures that arise in-field compared to the number that arise out-of-field. In-field failure will be defined as those where greater than 80% of the recurrence volume was encompassed by the 95% prescription isodose line. In addition, we will also describe failures by three types: unifocal, multifocal and diffuse (multicentric including leptomeningeal dissemination).
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.
Arm/Group Title No Treatment Group Assigned Group 1: SIB + IMRT Group 2: SRS Boost + IMRT
Hide Arm/Group Description:
For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
  • Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;
  • 3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
  • Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
  • Adjuvant Temozolomide Therapy for up to 12 cycles.

For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:

  • Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;
  • 3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
  • Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
  • Adjuvant Temozolomide Therapy for up to 12 cycles.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.
 
Arm/Group Title No Treatment Group Assigned Group 1: SIB + IMRT Group 2: SRS Boost + IMRT
Hide Arm/Group Description For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
  • Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;
  • 3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
  • Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
  • Adjuvant Temozolomide Therapy for up to 12 cycles.

For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:

  • Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;
  • 3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;
  • Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;
  • Adjuvant Temozolomide Therapy for up to 12 cycles.
All-Cause Mortality
No Treatment Group Assigned Group 1: SIB + IMRT Group 2: SRS Boost + IMRT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
No Treatment Group Assigned Group 1: SIB + IMRT Group 2: SRS Boost + IMRT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
No Treatment Group Assigned Group 1: SIB + IMRT Group 2: SRS Boost + IMRT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0   0/0 
Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.
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: Fazilat Ishkanian MD, PhD
Organization: University of Miami
Phone: 305-243-4200
EMail: f.ishkanian@med.miami.edu
Layout table for additonal information
Responsible Party: University of Miami
ClinicalTrials.gov Identifier: NCT02394665    
Other Study ID Numbers: 20140540
First Submitted: March 16, 2015
First Posted: March 20, 2015
Results First Submitted: November 8, 2016
Results First Posted: January 5, 2017
Last Update Posted: January 5, 2017