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

Phase 2

Completed

• Conditions: Brain and Central Nervous System Tumors
• Interventions: Drug: irinotecan hydrochloride; Drug: temozolomide; Procedure: adjuvant therapy; Radiation: radiation therapy

• Registration Number: NCT00099125
• Lead Sponsor: Radiation Therapy Oncology Group

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as temozolomide and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well radiation therapy, temozolomide, and irinotecan work in treating patients with newly diagnosed glioblastoma multiforme.

Detailed Description

OBJECTIVES:

* Compare overall survival of patients with newly diagnosed supratentorial glioblastoma multiforme treated with radiotherapy and temozolomide followed by temozolomide and irinotecan with historical controls from the RTOG database.

* Determine the short- and long-term toxicity of this regimen in these patients.

* Determine progression-free survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

* Chemoradiotherapy: Patients undergo radiotherapy once daily, 5 days a week, for 6 weeks. Concurrently with radiotherapy, patients receive oral temozolomide once daily, 7 days a week, for 6 weeks.

* Post-radiotherapy chemotherapy: Beginning 4-6 weeks after the completion of chemoradiotherapy, patients receive irinotecan IV on days 1 and 15 and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 157 patients will be accrued for this study within 11 months.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2004-12-08
• Study First Submitted QC: 2004-12-08
• Study First Posted: 2004-12-09
• Primary Completion: 2006-10
• Study Completion: 2013-11
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-23
• Last Update Posted: 2014-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RT with chemotherapy + post-radiation chemotherapy	adjuvant therapy	Radiation therapy (RT) with concurrent chemotherapy + post-radiation chemotherapy
RT with chemotherapy + post-radiation chemotherapy	temozolomide	Radiation therapy (RT) with concurrent chemotherapy + post-radiation chemotherapy
RT with chemotherapy + post-radiation chemotherapy	radiation therapy	Radiation therapy (RT) with concurrent chemotherapy + post-radiation chemotherapy
RT with chemotherapy + post-radiation chemotherapy	irinotecan hydrochloride	Radiation therapy (RT) with concurrent chemotherapy + post-radiation chemotherapy

Primary Outcome Measures

Name	Time	Method
Overall survival	From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	From randomization to date of progression, death, or last follow-up. Analysis occurs at the same time as the primary outcome analysis.

Trial Locations

Locations (118)

Foundation for Cancer Research and Education; 🇺🇸 Phoenix, Arizona, United States

Providence Saint Joseph Medical Center - Burbank; 🇺🇸 Burbank, California, United States

Saint Agnes Medical Center; 🇺🇸 Fresno, California, United States

Loma Linda University Cancer Institute at Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

Providence Holy Cross Cancer Center; 🇺🇸 Mission Hills, California, United States

Pomona Valley Hospital Medical Center; 🇺🇸 Pomona, California, United States

Radiological Associates of Sacramento Medical Group, Inc.; 🇺🇸 Sacramento, California, United States

Yale Comprehensive Cancer Center at Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

CCOP - Christiana Care Health Services; 🇺🇸 Newark, Delaware, United States

University of Florida Shands Cancer Center; 🇺🇸 Gainesville, Florida, United States

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