Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000389229 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
OUTLINE: This is a multicenter study.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RT with chemotherapy + post-radiation chemotherapy | Experimental | Radiation therapy (RT) with concurrent chemotherapy + post-radiation chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| irinotecan hydrochloride | Drug |
| ||
| temozolomide |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed supratentorial glioblastoma multiforme by surgical biopsy or excision
No tumor foci below the tentorium or beyond the cranial vault
Study therapy must begin ≤ 5 weeks after surgery
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
No prior radiotherapy to the head or neck resulting in overlap of radiotherapy fields
Surgery
Other
No enzyme-inducing antiepileptic drugs within 14 days before the initiation of irinotecan
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Frank S. Lieberman, MD | University of Pittsburgh | Study Chair |
| Christina I. Tsien, MD | University of Michigan Rogel Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foundation for Cancer Research and Education | Phoenix | Arizona | 85013 | United States | ||
| Providence Saint Joseph Medical Center - Burbank |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| adjuvant therapy | Procedure |
|
| radiation therapy | Radiation |
|
| Burbank |
| California |
| 91505 |
| United States |
| Saint Agnes Medical Center | Fresno | California | 93720 | United States |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
| Providence Holy Cross Cancer Center | Mission Hills | California | 91346-9600 | United States |
| Pomona Valley Hospital Medical Center | Pomona | California | 91767 | United States |
| Radiological Associates of Sacramento Medical Group, Inc. | Sacramento | California | 95815 | United States |
| Yale Comprehensive Cancer Center at Yale University School of Medicine | New Haven | Connecticut | 06520-8032 | United States |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19718 | United States |
| University of Florida Shands Cancer Center | Gainesville | Florida | 32610 | United States |
| Baptist Cancer Institute - Jacksonville | Jacksonville | Florida | 32207 | United States |
| John B. Amos Community Cancer Center | Columbus | Georgia | 31904 | United States |
| Regional Radiation Oncology Center at Rome | Rome | Georgia | 30165 | United States |
| Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise | Idaho | 83706 | United States |
| Northwest Community Hospital | Arlington Heights | Illinois | 60005 | United States |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611-3013 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey | Illinois | 60426 | United States |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| St. Francis Hospital and Health Centers | Beech Grove | Indiana | 46107 | United States |
| Tulane Cancer Center | New Orleans | Louisiana | 70112 | United States |
| CCOP - Ochsner | New Orleans | Louisiana | 70121 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
| Regional Cancer Center at Singing River Hospital | Pascagoula | Mississippi | 39581 | United States |
| Cancer Institute of Cape Girardeau | Cape Girardeau | Missouri | 63703 | United States |
| CCOP - Cancer Research for the Ozarks | Springfield | Missouri | 65802 | United States |
| St. John's Regional Health Center | Springfield | Missouri | 65804 | United States |
| Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri | 65807 | United States |
| Siteman Cancer Center at Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Methodist Cancer Center at Methodist Hospital - Omaha | Omaha | Nebraska | 68114 | United States |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| Dartmouth - Hitchcock Concord | Concord | New Hampshire | 03301 | United States |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Cancer Institute of New Jersey at the Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| Cooper Cancer Institute | Camden | New Jersey | 08103 | United States |
| John F. Kennedy Medical Center | Edison | New Jersey | 08818 | United States |
| Monmouth Medical Center | Long Branch | New Jersey | 07740 | United States |
| Community Medical Center | Toms River | New Jersey | 08755 | United States |
| University of New Mexico Cancer Research and Treatment Center | Albuquerque | New Mexico | 87106 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Lipson Cancer and Blood Center at Rochester General Hospital | Rochester | New York | 14621 | United States |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Randolph Hospital | Asheboro | North Carolina | 27203 | United States |
| Mission Hospitals - Memorial Campus | Asheville | North Carolina | 28801 | United States |
| John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital | Eden | North Carolina | 27288 | United States |
| Wayne Radiation Oncology | Goldsboro | North Carolina | 27534 | United States |
| Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro | North Carolina | 27401 | United States |
| Annie Penn Cancer Center | Reidsville | North Carolina | 27320 | United States |
| Akron City Hospital | Akron | Ohio | 44304 | United States |
| McDowell Cancer Center at Akron General Medical Center | Akron | Ohio | 44307 | United States |
| Radiation Oncology Center | Alliance | Ohio | 44601 | United States |
| Aultman Hospital Cancer Center at Aultman Health Foundation | Canton | Ohio | 44710 | United States |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio | 45267 | United States |
| CCOP - Columbus | Columbus | Ohio | 43215 | United States |
| Grandview Hospital | Dayton | Ohio | 45405 | United States |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| Veterans Affairs Medical Center - Dayton | Dayton | Ohio | 45428 | United States |
| Charles F. Kettering Memorial Hospital | Kettering | Ohio | 45429 | United States |
| Middletown Regional Hospital | Middletown | Ohio | 45044 | United States |
| Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | Salem | Ohio | 44460 | United States |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | 45373 | United States |
| Cancer Treatment Center | Wooster | Ohio | 44691 | United States |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | 45385 | United States |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma | 74136 | United States |
| Legacy Mount Hood Medical Center | Glesham | Oregon | 97030 | United States |
| Providence Milwaukie Hospital | Milwaukie | Oregon | 97222 | United States |
| Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center | Portland | Oregon | 97210 | United States |
| Providence Cancer Center at Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| CCOP - Columbia River Oncology Program | Portland | Oregon | 97225 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Institute of Oncology at Vilnius University | Portland | Oregon | 97227 | United States |
| Legacy Meridian Park Hospital | Tualatin | Oregon | 97062 | United States |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital | Allentown | Pennsylvania | 18105 | United States |
| St. Luke's Hospital Cancer Center | Bethlehem | Pennsylvania | 18015 | United States |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | United States |
| UPMC Cancer Center - Arnold Palmer Pavilion | Greensburg | Pennsylvania | 15601 | United States |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| UPMC McKeesport | McKeesport | Pennsylvania | 15132 | United States |
| Paoli Memorial Hospital | Paoli | Pennsylvania | 19301 | United States |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107 | United States |
| Albert Einstein Cancer Center | Philadelphia | Pennsylvania | 19141 | United States |
| Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15213 | United States |
| UPMC Cancer Center at Magee-Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| UPMC Cancer Center at UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | United States |
| UPMC St. Margaret | Pittsburgh | Pennsylvania | 15215 | United States |
| Mercy Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15219 | United States |
| UPMC - Shadyside | Pittsburgh | Pennsylvania | 15232 | United States |
| UPMC - Passavant Hospital | Pittsburgh | Pennsylvania | 15237 | United States |
| Cancer Center at St. Clair Memorial Hospital | Pittsburgh | Pennsylvania | 15243 | United States |
| Reading Hospital and Medical Center | West Reading | Pennsylvania | 19612 | United States |
| CCOP - MainLine Health | Wynnewood | Pennsylvania | 19096 | United States |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| York Cancer Center at Wellspan Health | York | Pennsylvania | 17405 | United States |
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29304 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | United States |
| Cottonwood Hospital Medical Center | Murray | Utah | 84107 | United States |
| McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Utah Valley Regional Medical Center - Provo | Provo | Utah | 84603 | United States |
| Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah | 84106 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Dixie Regional Medical Center | St. George | Utah | 84770 | United States |
| Green Mountain Oncology Group | Bennington | Vermont | 05201 | United States |
| Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | 05401 | United States |
| Community Cancer Center at Rutland Regional Medical Center | Rutland | Vermont | 05701 | United States |
| Massey Cancer Center at Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| CCOP - Virginia Mason Research Center | Seattle | Washington | 98101 | United States |
| Southwest Washington Medical Center Cancer Center | Vancouver | Washington | 98668 | United States |
| North Star Lodge Cancer Center | Yakima | Washington | 98902 | United States |
| St. Vincent Hospital | Green Bay | Wisconsin | 54301 | United States |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | 53792 | United States |
| Community Memorial Hospital | Menomonee Falls | Wisconsin | 53051 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| D000077204 | Temozolomide |
| D017024 | Chemotherapy, Adjuvant |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
Not provided
Not provided