MedDataX Logo

Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma

NCT ID: NCT00283543

Last Updated: 2007-10-31

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2008-04-30

Brief Summary

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

To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and radiation with Temozolomide

Detailed Description

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

A phase II study of radiation with concomitant and then sequential Temozolomide in patients with newly diagnosed supratentorial malignant glioma who have undergone surgery with Gliadel wafer insertion. To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and limited field radiation therapy with concomitant Temozolomide followed by Temozolomide alone in patients undergoing initial surgery for newly diagnosed unifocal moderate to high grade glioma.

Conditions

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

Newly Diagnosed Supratentorial Malignant Glioma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Glioma Gliadel Wafer

Study Design

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

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

Gliadel Wafer

Intervention Type DRUG

Temozolomide

Intervention Type DRUG

Limited field radiation

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* MRI showing unilateral supratentorial cerebral tumor
* surgical tx within 4 weeks of baseline MRI
* KPS 60% or higher
* moderate to high grade malignant glioma

Exclusion Criteria

* prior cytoreductive surgery for moderate or high grade glioma
* prior CNS radiotherapy
* prior chemo for this glioma
* more than one focus of tumor or tumor crossing the midline per MRI
* life expectancy less than 12 months
* sensitivity to temozolomide, nitrosoureas, or Gliadel wafer
Minimum Eligible Age

18 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eisai Inc.

INDUSTRY

Sponsor Role collaborator

Kentuckiana Cancer Institute

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Renato V. LaRocca, MD

Role: STUDY_DIRECTOR

Kentuckiana Cancer Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kentuckiana Cancer Institute

Louisville, Kentucky, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

128-02

Identifier Type: -

Identifier Source: secondary_id

1068016

Identifier Type: -

Identifier Source: org_study_id