NCT02099487

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2013

Typical duration for phase_2

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
7 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 31, 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
Last Updated

May 20, 2016

Status Verified

January 1, 2014

Enrollment Period

2.8 years

First QC Date

January 24, 2014

Last Update Submit

May 19, 2016

Conditions

Glioma

Keywords

HGG

Outcome Measures

Primary Outcomes (1)

  • PFS

    Progression free survival

    one year

Secondary Outcomes (1)

  • OS

    one year

Other Outcomes (2)

  • Toxicity

    one year

  • QoL

    one year

Study Arms (1)

Radiation

EXPERIMENTAL

To evaluate safety and feasibility of hypofractionated Intensity Modulated Radiotherapy

Radiation: Radiation

Interventions

RadiationRADIATION

hypofractionated IMRT

Radiation

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prior radiation therapy
  • Other primary cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICH Humanitas Cancer Center

Milan, Lombardy, 20090, Italy

Location

MeSH Terms

Conditions

Glioma

Interventions

Radiation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

  • Piera Navarria, MD

    Humanitas Cancer Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

January 24, 2014

First Posted

March 31, 2014

Study Start

July 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 20, 2016

Record last verified: 2014-01

Locations

IT(1)