Radiation Therapy, Temozolomide, and Irinotecan in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
NCT ID: NCT00099125
Last Updated: 2014-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
170 participants
INTERVENTIONAL
2004-11-30
2013-11-30
Brief Summary
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PURPOSE: This phase II trial is studying how well radiation therapy, temozolomide, and irinotecan work in treating patients with newly diagnosed glioblastoma multiforme.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RT with chemotherapy + post-radiation chemotherapy
Radiation therapy (RT) with concurrent chemotherapy + post-radiation chemotherapy
irinotecan hydrochloride
temozolomide
adjuvant therapy
radiation therapy
Interventions
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irinotecan hydrochloride
temozolomide
adjuvant therapy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed newly diagnosed supratentorial glioblastoma multiforme by surgical biopsy or excision
* No gliomas graded less than glioblastoma multiforme
* No recurrent malignant gliomas
* No tumor foci below the tentorium or beyond the cranial vault
* Study therapy must begin ≤ 5 weeks after surgery
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-1
Life expectancy
* At least 8 weeks
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10 g/dL\*
* Hematocrit ≥ 30%\* NOTE: \*Transfusion allowed
Hepatic
* Bilirubin ≤ 0.5 mg/dL
* ALT or AST ≤ 2 times upper limit of normal
Renal
* Creatinine ≤ 1.5 mg/dL
* BUN ≤ 25 mg/dL
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective double-barrier contraception during and for 2 months after study participation
* No AIDS
* No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or bladder
* No other major medical illness or psychiatric impairment that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent sargramostim (GM-CSF)
Chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* Concurrent steroid therapy allowed provided patient is on a stable or decreasing dose for at least 2 weeks before study entry
Radiotherapy
* No prior radiotherapy to the head or neck resulting in overlap of radiotherapy fields
* Prior radiotherapy for stage T1 glottic cancer allowed
Surgery
* See Disease Characteristics
* Recovered from prior surgery
Other
* No enzyme-inducing antiepileptic drugs within 14 days before the initiation of irinotecan
* Concurrent non-enzyme-inducing antiepileptic drugs allowed
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Frank S. Lieberman, MD
Role: STUDY_CHAIR
University of Pittsburgh
Christina I. Tsien, MD
Role: STUDY_CHAIR
University of Michigan Rogel Cancer Center
Locations
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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
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States
John B. Amos Community Cancer Center
Columbus, Georgia, United States
Regional Radiation Oncology Center at Rome
Rome, Georgia, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
Northwest Community Hospital
Arlington Heights, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States
St. Francis Hospital and Health Centers
Beech Grove, Indiana, United States
Tulane Cancer Center
New Orleans, Louisiana, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States
Cancer Institute of Cape Girardeau
Cape Girardeau, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. John's Regional Health Center
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Dartmouth - Hitchcock Concord
Concord, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cancer Institute of New Jersey at the Cooper University Hospital
Camden, New Jersey, United States
Cooper Cancer Institute
Camden, New Jersey, United States
John F. Kennedy Medical Center
Edison, New Jersey, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Community Medical Center
Toms River, New Jersey, United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Lipson Cancer and Blood Center at Rochester General Hospital
Rochester, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Randolph Hospital
Asheboro, North Carolina, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States
John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital
Eden, North Carolina, United States
Wayne Radiation Oncology
Goldsboro, North Carolina, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, United States
Annie Penn Cancer Center
Reidsville, North Carolina, United States
Akron City Hospital
Akron, Ohio, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States
Radiation Oncology Center
Alliance, Ohio, United States
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Grandview Hospital
Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States
Middletown Regional Hospital
Middletown, Ohio, United States
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
Salem, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States
Cancer Treatment Center
Wooster, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States
Legacy Mount Hood Medical Center
Glesham, Oregon, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, United States
Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center
Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Institute of Oncology at Vilnius University
Portland, Oregon, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
Allentown, Pennsylvania, United States
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
UPMC Cancer Center - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
UPMC McKeesport
McKeesport, Pennsylvania, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
UPMC St. Margaret
Pittsburgh, Pennsylvania, United States
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
UPMC - Shadyside
Pittsburgh, Pennsylvania, United States
UPMC - Passavant Hospital
Pittsburgh, Pennsylvania, United States
Cancer Center at St. Clair Memorial Hospital
Pittsburgh, Pennsylvania, United States
Reading Hospital and Medical Center
West Reading, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States
York Cancer Center at Wellspan Health
York, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Cottonwood Hospital Medical Center
Murray, Utah, United States
McKay-Dee Hospital Center
Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Dixie Regional Medical Center
St. George, Utah, United States
Green Mountain Oncology Group
Bennington, Vermont, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States
Community Cancer Center at Rutland Regional Medical Center
Rutland, Vermont, United States
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States
North Star Lodge Cancer Center
Yakima, Washington, United States
St. Vincent Hospital
Green Bay, Wisconsin, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Community Memorial Hospital
Menomonee Falls, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Countries
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References
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Lieberman FS, Tsien C, Berkey B, et al.: Phase II trial of concomitant low dose temozolomide with external beam radiation (EBRT) followed by 12 months of temozolomide and irinotecan for newly diagnosed glioblastoma (GBM): preliminary results of RTOG 04-20. [Abstract] J Clin Oncol 24 (Suppl 18): A-1510, 2006.
Other Identifiers
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CDR0000389229
Identifier Type: -
Identifier Source: secondary_id
RTOG-0420
Identifier Type: -
Identifier Source: org_study_id
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