Hypofractionated IMRT With Temozolomide for HGG
Primary Purpose
Glioma
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Hypofractionated IMRT
Sponsored by
About this trial
This is an interventional treatment trial for Glioma
Eligibility Criteria
Inclusion Criteria:
- Age 18 to 70 years
- Karnosky performance status (KPS) ≥60
- Patients aged >70 years with KPS ≥80
- Histopathologically confirmed of HGG
- Estimated survival ≥ 3 months.
- Multifocal tumor
- Normal liver, Kidney and bone marrow function
- Written informed consent
Exclusion Criteria:
- Prior radiation therapy
- KPS ≤ 60
- Age > 70 years and KPS < 70
- Other primary cancer
- Pregnant women
Sites / Locations
- Istituto Clinico Humanitas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
High Grade Glioma
Arm Description
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.
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS)
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.
Secondary Outcome Measures
Quality of Life (QoL) of Patients After Surgery, Concomitant Chemo-radiotherapy and Adjuvant Chemotherapy
Quality 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.
Full Information
NCT ID
NCT02082119
First Posted
December 13, 2013
Last Updated
September 17, 2020
Sponsor
Istituto Clinico Humanitas
1. Study Identification
Unique Protocol Identification Number
NCT02082119
Brief Title
Hypofractionated IMRT With Temozolomide for HGG
Official Title
Hypofractionated IMRT (VMAT-RA) With Temozolomide for Patients With Newly Diagnosed High Grade Glioma (HGG)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Clinico Humanitas
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate safety and feasibility of hypofractionated IMRT in addition to chemotherapy, concomitant and adjuvant, in patients with newly diagnosed HGGs after surgery.
Primary endpoint: progression free survival (PFS), Overall Survival (OS) and Toxicity.
Secondary endpoint: to evaluate Quality of life (QoL) of patients after surgery, concomitant chemoradiotherapy and adjuvant chemotherapy through neuropsychological examination.
Detailed Description
We designed a study of a hypofractionated intensity modulated radiation therapy (IMRT), using VMAT RapidArc approach. The potential advantage of this approach is to deliver a more selective irradiation to tumor's target with reducing dose to normal brain and to allow to deliver a higher dose, optimizing the therapeutic window
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Grade Glioma
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated IMRT
Intervention Description
Hypofractionated IMRT
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Quality of Life (QoL) of Patients After Surgery, Concomitant Chemo-radiotherapy and Adjuvant Chemotherapy
Description
Quality 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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 to 70 years
Karnosky performance status (KPS) ≥60
Patients aged >70 years with KPS ≥80
Histopathologically confirmed of HGG
Estimated survival ≥ 3 months.
Multifocal tumor
Normal liver, Kidney and bone marrow function
Written informed consent
Exclusion Criteria:
Prior radiation therapy
KPS ≤ 60
Age > 70 years and KPS < 70
Other primary cancer
Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piera Navarria, MD
Organizational Affiliation
Humanitas Cancer Center
Official's Role
Study Director
Facility Information:
Facility Name
Istituto Clinico Humanitas
City
Milan
ZIP/Postal Code
20100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
22483738
Citation
Reddy K, Damek D, Gaspar LE, Ney D, Waziri A, Lillehei K, Stuhr K, Kavanagh BD, Chen C. Phase II trial of hypofractionated IMRT with temozolomide for patients with newly diagnosed glioblastoma multiforme. Int J Radiat Oncol Biol Phys. 2012 Nov 1;84(3):655-60. doi: 10.1016/j.ijrobp.2012.01.035. Epub 2012 Apr 5.
Results Reference
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Hypofractionated IMRT With Temozolomide for HGG
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