Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003996
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme
Detailed Description:
OBJECTIVES I Evaluate the efficacy of carmustine cisplatin and etoposide administered prior to and during radiotherapy in patients with newly diagnosed high grade glioblastoma multiforme II Assess the toxicities of this treatment regimen in this patient population III Assess fatigue depression and excessive daytime somnolence in terms of incidence duration and relation to age tumor type tumor site cancer therapy and symptoms in this patient population IV Evaluate the quality of life of these patients
OUTLINE 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
OUTLINE 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000067206 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02308 | REGISTRY | None | None |