NCT00003996|CompletedPhase 2

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

A Phase II Trial of Pre-irradiation Chemotherapy With BCNU, Cisplatin and Oral Etoposide Combined With Radiation Therapy in the Treatment of Grade 4 Astrocytoma (Glioblastoma)

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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3 other identifiers

NCCTG-987252NCI-2012-02308CDR0000067206

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJun 2004

StartedMay 1999

CompletionMay 2008

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started May 1999

Longer than P75 for phase_2

Geographic Reach

1 country

19 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

9 years study duration

Study Start

First participant enrolled

May 1, 1999

Completed

6 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2001

Completed

2.9 years until next milestone

First Posted

Study publicly available on registry

June 17, 2004

Completed

3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed

Last Updated

December 7, 2016

Status Verified

December 1, 2016

Enrollment Period

2.3 years

First QC Date

November 1, 1999

Last Update Submit

December 5, 2016

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastomaadult giant cell glioblastomaadult gliosarcoma

Outcome Measures

Primary Outcomes (1)

overall survival
Up to 10 years

Secondary Outcomes (1)

quality of life
Up to 10 years

Study Arms (1)

chemotherapy + carmustine + etoposide + cisplatin + radiation

EXPERIMENTAL

Patients receive pre-irradiation chemotherapy consisting of carmustine IV over 1 hour on days 1-3 and oral etoposide on days 1-21 and 29-49 immediately followed by cisplatin IV over 1-2 hours on days 1-3 and 29-31. Treatment repeats every 8 weeks for 2 courses. Patients receive concurrent cranial radiotherapy daily over 8 weeks during course 2. Patients then receive carmustine IV over 1-2 hours every 8 weeks for 4 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before the study, prior to each treatment course, every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years. Patients are followed every 4 months for 1 year, every 6 months for 4 years, annually for 5 years, and then for survival.

Drug: carmustineDrug: chemotherapyDrug: cisplatinDrug: etoposideRadiation: radiation therapy