Trial Outcomes & Findings for Dose Escalated MRSI Guided Radiation Therapy in Glioblastoma (NCT NCT02394665)
NCT ID: NCT02394665
Last Updated: 2017-01-05
Results Overview
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.
TERMINATED
PHASE2
1 participants
Up to 2 years
2017-01-05
Participant Flow
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 Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.
Participant milestones
| Measure |
No Treatment Group Assigned
For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
|
Group 1: SIB + IMRT
* 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.
|
Group 2: SRS Boost + IMRT
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 Study
STARTED
|
1
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
No Treatment Group Assigned
For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
|
Group 1: SIB + IMRT
* 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.
|
Group 2: SRS Boost + IMRT
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 Study
Physician Decision
|
1
|
0
|
0
|
Baseline Characteristics
Dose Escalated MRSI Guided Radiation Therapy in Glioblastoma
Baseline characteristics by cohort
| Measure |
No Treatment Group Assigned
n=1 Participants
For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
|
Group 1: SIB + IMRT
* 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.
|
Group 2: SRS Boost + IMRT
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
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Gender
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Gender
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
—
|
1 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: 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.
Rate of Grade 3 of Higher Toxicity in study participants as a consequence of study therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: 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.
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).
Outcome measures
Outcome data not reported
Adverse Events
No Treatment Group Assigned
Group 1: SIB + IMRT
Group 2: SRS Boost + IMRT
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place