Hypofractionated IMRT With Temozolomide for HGG

• Sponsor: Istituto Clinico Humanitas (Other)
• Overall Status: Completed
• CT.gov ID: NCT02082119
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arm: 1
• Duration (Months): 34
• Patients Per Site Per Month: 2.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glioma	Radiation: Hypofractionated IMRT	N/A

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

Study Design

• Study Type: Interventional
• 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: Jul 1, 2013
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival (PFS) [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituto Clinico Humanitas	Milan		Italy	20100

Sponsors and Collaborators

• Istituto Clinico Humanitas

Investigators

• Study Director: Piera Navarria, MD, Humanitas Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Michele Tedeschi, Istituto Clinico Humanitas, Istituto Clinico Humanitas
• ClinicalTrials.gov Identifier: NCT02082119
• Other Study ID Numbers: 1138
• First Posted: Mar 10, 2014
• Last Update Posted: Oct 12, 2020
• Last Verified: Sep 1, 2020

• Additional relevant MeSH terms: Glioma

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	High Grade Glioma
Arm/Group 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. Hypofractionated IMRT: Hypofractionated IMRT
Period Title: Overall Study
STARTED	82
COMPLETED	82
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	High Grade Glioma
Arm/Group 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. Hypofractionated IMRT: Hypofractionated IMRT
Overall Participants	82
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	60 73.2%
>=65 years	22 26.8%
Sex: Female, Male (Count of Participants)
Female	30 36.6%
Male	52 63.4%
Region of Enrollment (participants) [Number]
Italy	82 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients with newly diagnosed high grade glioma were analysed.

Arm/Group Title	High Grade Glioma
Arm/Group 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. Hypofractionated IMRT: Hypofractionated IMRT
Measure Participants	82
Count of Participants [Participants]	82 100%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	High Grade Glioma
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 1 sided
	Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	High Grade Glioma
Arm/Group 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. Hypofractionated IMRT: Hypofractionated IMRT
All Cause Mortality
	High Grade Glioma
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	High Grade Glioma
	Affected / at Risk (%)	# Events
Total	0/82 (0%)
Other (Not Including Serious) Adverse Events
	High Grade Glioma
	Affected / at Risk (%)	# Events
Total	0/82 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.