NCT02567539

Brief Summary

The study is aimed to evaluate efficacy and safety of re-irradiation for patients with recurrent high grade gliomas after other treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 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

May 27, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2015

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

7 years

First QC Date

September 28, 2015

Last Update Submit

September 14, 2022

Conditions

Recurrent High Grade Glioma

Outcome Measures

Primary Outcomes (2)

  • Progression free of participants

    4 years

  • Overall survival of participants

    4 years

Secondary Outcomes (2)

  • Incidence of radionecrosis

    3 months

  • Questionnaire assessment of neurocognitive function

    6 months

Study Arms (1)

Recurrent high grade glioma

EXPERIMENTAL

IMRT with or without radiosensitive therapy

Radiation: IMRT with or without radiosensitive therapyDrug: Radiosensitive therapy

Interventions

IMRT with or without radiosensitive therapyRADIATION

Re-irradiation with hypofractionated intensity modulated radiation therapy (IMRT), using VMAT RapidArc

Also known as: Hypofractionated Stereotactic Radiation
Recurrent high grade glioma
Radiosensitive therapyDRUG

Radiosensitive therapy with Temozolomide

Also known as: Chemotherapy
Recurrent high grade glioma

Eligibility Criteria

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

You may qualify if:

  • Age \> 18 years
  • Karnosky performance status (KPS) ≥70
  • Patients aged \>70 years with KPS ≥80
  • Histopathologically confirmed grade III-IV glioma
  • Estimated survival ≥ 3 months
  • Any Tumor volume
  • Unifocal tumor
  • Interval time from previous radiotherapy ≥ 6mesi
  • Normal liver, Kidney and bone marrow function
  • Written informed consent

You may not qualify if:

  • KPS \< 70
  • Multifocal tumor
  • Other primary cancer
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

Location

Related Publications (3)

  • Navarria P, Ascolese AM, Tomatis S, Reggiori G, Clerici E, Villa E, Maggi G, Bello L, Pessina F, Cozzi L, Scorsetti M. Hypofractionated Stereotactic Radiation Therapy in Recurrent High-Grade Glioma: A New Challenge. Cancer Res Treat. 2016 Jan;48(1):37-44. doi: 10.4143/crt.2014.259. Epub 2015 Feb 23.

    PMID: 25761491RESULT

  • Scorsetti M, Navarria P, Pessina F, Ascolese AM, D'Agostino G, Tomatis S, De Rose F, Villa E, Maggi G, Simonelli M, Clerici E, Soffietti R, Santoro A, Cozzi L, Bello L. Multimodality therapy approaches, local and systemic treatment, compared with chemotherapy alone in recurrent glioblastoma. BMC Cancer. 2015 Jun 30;15:486. doi: 10.1186/s12885-015-1488-2.

    PMID: 26118437RESULT

  • Navarria P, Pessina F, Clerici E, Bellu L, Franzese C, Franzini A, Simonelli M, Bello L, Santoro A, Politi LS, D'agostino GR, Casarotti A, Fernandes B, Torri V, Scorsetti M. Re-irradiation for recurrent high grade glioma (HGG) patients: Results of a single arm prospective phase 2 study. Radiother Oncol. 2022 Feb;167:89-96. doi: 10.1016/j.radonc.2021.12.019. Epub 2021 Dec 22.

    PMID: 34952000DERIVED

MeSH Terms

Conditions

Glioma

Interventions

Radiotherapy, Intensity-ModulatedDrug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Piera Navarria, MD

    Istituto Clinico Humanitas

    PRINCIPAL INVESTIGATOR

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
MD

Study Record Dates

First Submitted

September 28, 2015

First Posted

October 5, 2015

Study Start

May 27, 2015

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

September 15, 2022

Record last verified: 2022-09

Locations

IT(1)