A Phase III Study of Re-Irradiation in Recurrent Glioblastoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators hope to improve overall median survival of patients with recurrent Glioblastoma by investigating continuous low-dose daily Temozolomide plus or minus five treatments of re-irradiation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase II Trial of Low-Dose Whole Brain Radiotherapy With Concurrent Temozolomide and Adjuvant Temozolomide in Patients With Newly-Diagnosed Glioblastoma Multiforme

NCT01822275

Histologically Proven Diagnosis of Glioblastoma or Gliosarcoma (WHO Grade IV)

TERMINATED PHASE2

Metronomic Temozolamide in Patients With Recurrent Glioblastoma

NCT01308632

Glioblastoma

UNKNOWN PHASE2/PHASE3

Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma

NCT00304031

Brain and Central Nervous System Tumors

COMPLETED PHASE3

Temsirolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

NCT00316849

Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma

COMPLETED PHASE1

Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma

NCT00005951

Brain and Central Nervous System Tumors

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a stratified study for patients with recurrent intracranial glioblastoma or gliosarcoma previously treated with concurrent chemoradiation presenting radiographic progression or recurrence of tumour. Patients are stratified by extent of resection, time to re-irradiation and re-irradiation volume.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Recurrent Glioblastoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TMZ plus concurrent re-irradiation

Group Type EXPERIMENTAL

TMZ plus concurrent re-irradiation

Intervention Type DRUG

Temozolomide

Intervention Type DRUG

low-dose temozolomide daily for one year

TMZ alone

Group Type EXPERIMENTAL

TMZ plus concurrent re-irradiation

Intervention Type DRUG

Temozolomide

Intervention Type DRUG

low-dose temozolomide daily for one year

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TMZ plus concurrent re-irradiation

Intervention Type DRUG

Temozolomide

low-dose temozolomide daily for one year

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Temedol Temedol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* histologically-proven intracranial glioblastoma or gliosarcoma previously treated with concurrent chemoradiation
* radiographic evidence of tumour progression or recurrence
* 18 years or older
* ECOG 0 - 2
* signed informed consent form

Exclusion Criteria

* tumour progression or recurrence within 3 months of initial concurrent chemoradiation
* 6 or more cycles of TMZ administered following chemoradiation at initial diagnosis
* more than one prior course of salvage chemo for recurrent disease
* prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for greater or equal to 3 years
* prior head or neck RT except for T1 glottic cancer

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No