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Hypofractionated IMRT With Temozolomide for HGG

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ClinicalTrials.gov Identifier: NCT02082119
Recruitment Status : Completed
First Posted : March 10, 2014
Results First Posted : October 12, 2020
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Michele Tedeschi, Istituto Clinico Humanitas

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.


Condition or disease Intervention/treatment Phase
Glioma Radiation: Hypofractionated IMRT Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypofractionated IMRT (VMAT-RA) With Temozolomide for Patients With Newly Diagnosed High Grade Glioma (HGG)
Study Start Date : July 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Radiation: Hypofractionated IMRT
Hypofractionated IMRT




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 1 year ]
    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 :
  1. Quality of Life (QoL) of Patients After Surgery, Concomitant Chemo-radiotherapy and Adjuvant Chemotherapy [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082119


Locations
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Italy
Istituto Clinico Humanitas
Milan, Italy, 20100
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
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Study Director: Piera Navarria, MD Humanitas Cancer Center
Publications:
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Responsible Party: Michele Tedeschi, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT02082119    
Other Study ID Numbers: 1138
First Posted: March 10, 2014    Key Record Dates
Results First Posted: October 12, 2020
Last Update Posted: October 12, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue