Hypofractionated Imrt (Vmat-Ra) For Elderly Patients With... | NCT02099487

Studies
Hypofractionated Imrt (Vmat-Ra) For Elderly Patients With Newly Diagnosed High Grade Glioma

NCT02099487

Sponsor

Istituto Clinico Humanitas

Status

Completed

Last Update Posted

May 20, 2016Estimated

Enrollment

20Actual

Phase

Phase 2

Conditions

Glioma

Interventions

Radiation

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Jan 24, 2014

First Submission Date that Met QC Criteria

Mar 25, 2014

First Posted Date

Mar 31, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2016

Last Update Posted Date

May 20, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To assess the effect of IMRT using VMAT rapidarc approach, followed by adjuvant temozolomide on survival and quality of life in elderly, poor performance status patients with newly diagnosed HGG.

Detailed Description

Investigators designed this study with the aim to assess the effect of IMRT using VMAT rapidarc approach, followed by adjuvant temozolomide on survival and quality of life in elderly, poor performance status patients with newly diagnosed HGG. The potential advantage of this approach is deliver a more selective irradiation to tumor's target with reducing the dose to normal brain and to allow the delivery of a higher dose, optimizing the therapeutic window.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Radiation	Experimental	To evaluate safety and feasibility of hypofractionated Intensity Modulated Radiotherapy	Radiation: Radiation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiation	Radiation	hypofractionated IMRT	Radiation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PFS	Progression free survival	one year

Secondary Outcomes

Measure	Description	Time Frame
OS	Overall Survival	one year

Other Outcomes

Measure	Description	Time Frame
Toxicity	Incidence of hematologic and non hematologic severe toxicities (grade III/ IV) will evaluate using NCI-CTCA scale. Late toxicity will evaluate using CTCA 4.2	one year
QoL	Quality of Life

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged ≥ 70 years
Karnosky performance status (KPS) ≤60
Histologically confirmed HGG after tumor biopsy
- GBM
- Anaplastic Astrocytoma
- Anaplastic Oligoastrocytoma
- Anaplastic Oligodendroglioma without IDH1 mutation and no codeletion 1p19q
Estimated survival ≥ 3 months.
Normal liver, Kidney and bone marrow function
Written informed consent

Exclusion criteria:

Prior radiation therapy
Other primary cancer

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Piera Navarria, MD	Humanitas Cancer Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ICH Humanitas Cancer Center		Milan	Lombardy	20090	Italy

Condition Browse Module

MeSH Terms

ID	Term
D005910	Glioma

Ancestor Terms

ID	Term
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided