Trial Outcomes & Findings for Hypofractionated IMRT With Temozolomide for HGG (NCT NCT02082119)
NCT ID: NCT02082119
Last Updated: 2020-10-12
Results Overview
Progression free survival is defined by any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids; a significant increase in T2/FLAIR non-enhancing lesions on stable or increasing dose of corticosteroids compared with baseline scan or best response after initial of therapy, not due to comorbid events; the appearance of any new lesions; clear progression of non-measurable lesions; or definite clinical deterioration not attributable to another causes apart from the tumor, or to decrease in corticosteroid dose.
COMPLETED
NA
82 participants
1 year
2020-10-12
Participant Flow
Considering a time of enrollment of 2 years and a follow-up time of 2 years, 82 patients are evaluated from June 2013 to May 2015. Patients with newly diagnosed HGGs underwent hypofractionated IMRT in addition to chemotherapy, concomitant and adjuvant, after biopsy, subtotal or gross total surgical resection.
Participant milestones
| Measure |
High Grade Glioma
To evaluate safety and feasibility of hypofractionated IMRT in addition to chemotherapy, concomitant and adjuvant, in patients with newly diagnosed High Grade Glioma after biopsy.total dose of 60 Gy/ 4 Gy fraction/15 fractions (BED10 84 Gy) will prescribed to the PTV1; a total dose of 42 Gy/2.8 Gy fraction/15 fractions (BED10 53.76 Gy) will prescribed to PTV2 with SIB.
Hypofractionated IMRT: Hypofractionated IMRT
|
|---|---|
|
Overall Study
STARTED
|
82
|
|
Overall Study
COMPLETED
|
82
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hypofractionated IMRT With Temozolomide for HGG
Baseline characteristics by cohort
| Measure |
High Grade Glioma
n=82 Participants
To evaluate safety and feasibility of hypofractionated IMRT in addition to chemotherapy, concomitant and adjuvant, in patients with newly diagnosed High Grade Glioma after biopsy.total dose of 60 Gy/ 4 Gy fraction/15 fractions (BED10 84 Gy) will prescribed to the PTV1; a total dose of 42 Gy/2.8 Gy fraction/15 fractions (BED10 53.76 Gy) will prescribed to PTV2 with SIB.
Hypofractionated IMRT: Hypofractionated IMRT
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
82 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Patients with newly diagnosed high grade glioma were analysed.
Progression free survival is defined by any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids; a significant increase in T2/FLAIR non-enhancing lesions on stable or increasing dose of corticosteroids compared with baseline scan or best response after initial of therapy, not due to comorbid events; the appearance of any new lesions; clear progression of non-measurable lesions; or definite clinical deterioration not attributable to another causes apart from the tumor, or to decrease in corticosteroid dose.
Outcome measures
| Measure |
High Grade Glioma
n=82 Participants
To evaluate safety and feasibility of hypofractionated IMRT in addition to chemotherapy, concomitant and adjuvant, in patients with newly diagnosed High Grade Glioma after biopsy.total dose of 60 Gy/ 4 Gy fraction/15 fractions (BED10 84 Gy) will prescribed to the PTV1; a total dose of 42 Gy/2.8 Gy fraction/15 fractions (BED10 53.76 Gy) will prescribed to PTV2 with SIB.
Hypofractionated IMRT: Hypofractionated IMRT
|
|---|---|
|
Progression Free Survival (PFS)
|
82 Participants
|
SECONDARY outcome
Timeframe: 1 yearQuality of life (QoL) of patients after surgery, concomitant chemoradiotherapy and adjuvant chemotherapy is evaluated through neuropsychological examination using the Milano-Bicocca Battery (MIBIB). This battery investigated language, memory, apraxia, including visuo-constructional abilities, executive functions and spatial cognition.
Outcome measures
Outcome data not reported
Adverse Events
High Grade Glioma
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