NCT02082119

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 10, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

October 12, 2020

Completed
Last Updated

October 12, 2020

Status Verified

September 1, 2020

Enrollment Period

2.8 years

First QC Date

December 13, 2013

Results QC Date

December 13, 2016

Last Update Submit

September 17, 2020

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (1)

  • Quality of Life (QoL) of Patients After Surgery, Concomitant Chemo-radiotherapy and Adjuvant Chemotherapy

    1 year

Study Arms (1)

High Grade Glioma

EXPERIMENTAL

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

Interventions

Hypofractionated IMRTRADIATION

Hypofractionated IMRT

High Grade Glioma

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prior radiation therapy
  • KPS ≤ 60
  • Age \> 70 years and KPS \< 70
  • Other primary cancer
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Clinico Humanitas

Milan, 20100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 22483738BACKGROUND

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Results Point of Contact

Title
Dr. Marta Scorsetti
Organization
Humanitas Cancer Center
marta.scorsetti@hunimed.eu
+390282248524

Study Officials

  • Piera Navarria, MD

    Humanitas Cancer Center

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Istituto Clinico Humanitas

Study Record Dates

First Submitted

December 13, 2013

First Posted

March 10, 2014

Study Start

July 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

October 12, 2020

Results First Posted

October 12, 2020

Record last verified: 2020-09

Locations

IT(1)