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| ID | Type | Description | Link |
|---|---|---|---|
| COG-ACNS0221 | Other Identifier | Clinical Trials.gov | |
| CIRB-05016 | Other Identifier | Pediatric CIRB | |
| CDR0000445095 | Other Identifier | Clinical Trials.gov |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Specialized radiation therapy that delivers radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase II trial is studying how well radiation therapy works in treating young patients with gliomas.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients undergo reduced-field conformal radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline or 6 weeks after completion of study treatment and then at 2 and 5 years (closed as of 10/27/2010).
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (radiotherapy) | Experimental | Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiation therapy | Radiation | Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Marginal-failure Rate | Patients who do not recur as well as those with either central or distant recurrence would be treatment successes for this endpoint. Monitoring will be based on a Bayesian rule, with binomial likelihood and a Beta on the parameter p, the proportion of failures that are marginal failures. | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival Probability | To estimate the progression-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation. | 3 years |
| Event-free Survival Probability |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed* low-grade glioma, including any of the following:
Juvenile pilocytic astrocytoma (JPA) or pleomorphic JPA
Diffuse astrocytoma, including any of the following subtypes:
Low-grade oligoastrocytoma
Low-grade oligodendroglioma
Low-grade glioma not otherwise specified NOTE: *Patients with chiasmatic lesions who have contiguous extension of tumor into other regions of the visual pathway by CT scan or MRI are eligible without histopathologic confirmation; repeat biopsy required for patients with recurrent tumors that enhance but whose initial tumor did not
Measurable disease by radiography
Meets any of the following criteria:
Progressive nonresectable disease
Patients with a less than gross total resection are eligible provided they are symptomatic from their tumor OR the risk from neurologic impairment with progression is high enough to warrant immediate treatment
Has undergone biopsy only
Must have received ≥ 1 course of prior chemotherapy (for patients < 10 years of age)
No type-1 neurofibromatosis
No evidence of leptomeningeal dissemination
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Joel M. Cherlow, MD | Todd Cancer Institute at Long Beach Memorial Medical Center | Study Chair |
| Edward G. Shaw, MD | Wake Forest University Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Comprehensive Cancer Center | Birmingham | Alabama | 35294 | United States | ||
| Phoenix Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20381270 | Result | Ulin K, Urie MM, Cherlow JM. Results of a multi-institutional benchmark test for cranial CT/MR image registration. Int J Radiat Oncol Biol Phys. 2010 Aug 1;77(5):1584-9. doi: 10.1016/j.ijrobp.2009.10.017. Epub 2010 Apr 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reduced-field Conformal Radiation Therapy | Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity. radiation therapy: Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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To estimate the event-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation |
| 3 years |
| Overall Survival Probability | To estimate the overall survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation. | 3 years |
| Quality of Life (QOL) | QOL accessed using the Behavior Assessment System for Children (BASC), the Adaptive Behavior Assessment System (ABAS), the Behavior Rating Inventory of Executive Function (BRIEF), and the Symptom Checklist-90-R (SCL-90-R). | Up to 5 years |
| MIB-1 Labeling Index Using Immunohistochemical Techniques With the MIB-1 Antibody According to Established Methods | The MIB-1 labeling Index will be calculated as the percentage of tumor nuclei that are immunoreactive. | At baseline |
| Correlation MIB-1 Labeling Index With PFS | The primary methods of analysis will be via stratified Cox regression | Up to 10 years |
| Phoenix |
| Arizona |
| 85016-7710 |
| United States |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| Southern California Permanente Medical Group | Downey | California | 90027 | United States |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
| Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Long Beach | California | 90801 | United States |
| Childrens Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Los Angeles | California | 90048-1865 | United States |
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California | 90095-1781 | United States |
| Children's Hospital Central California | Madera | California | 93638-8762 | United States |
| Children's Hospital and Research Center Oakland | Oakland | California | 94609 | United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| University of California Davis Cancer Center | Sacramento | California | 95817 | United States |
| Kaiser Permanente Medical Center - Oakland | Sacramento | California | 95825 | United States |
| Rady Children's Hospital - San Diego | San Diego | California | 92123-4282 | United States |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
| Children's Hospital Center for Cancer and Blood Disorders | Aurora | Colorado | 80045 | United States |
| Presbyterian - St. Luke's Medical Center | Denver | Colorado | 80218 | United States |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307-5001 | United States |
| Lee Cancer Care of Lee Memorial Health System | Fort Myers | Florida | 33901 | United States |
| Memorial Cancer Institute at Memorial Regional Hospital | Hollywood | Florida | 33021 | United States |
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida | 33136 | United States |
| Miami Children's Hospital | Miami | Florida | 33155 | United States |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando | Florida | 32803-1273 | United States |
| M.D. Anderson Cancer Center at Orlando | Orlando | Florida | 32806 | United States |
| Nemours Children's Clinic - Orlando | Orlando | Florida | 32806 | United States |
| Sacred Heart Cancer Center at Sacred Heart Hospital | Pensacola | Florida | 32504 | United States |
| All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa | Florida | 33607 | United States |
| Kaplan Cancer Center at St. Mary's Medical Center | West Palm Beach | Florida | 33407 | United States |
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | Atlanta | Georgia | 30322 | United States |
| MBCCOP - Medical College of Georgia Cancer Center | Augusta | Georgia | 30912-3730 | United States |
| Cancer Research Center of Hawaii | Honolulu | Hawaii | 96813 | United States |
| Mountain States Tumor Institute at St. Luke's Regional Medical Center | Boise | Idaho | 83712-6297 | United States |
| University of Illinois Cancer Center | Chicago | Illinois | 60612-7243 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Keyser Family Cancer Center at Advocate Hope Children's Hospital | Oak Lawn | Illinois | 60453 | United States |
| Advocate Lutheran General Cancer Care Center | Park Ridge | Illinois | 60068-1174 | United States |
| Saint Jude Midwest Affiliate | Peoria | Illinois | 61637 | United States |
| Simmons Cooper Cancer Institute | Springfield | Illinois | 62794-9677 | United States |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202-5289 | United States |
| St. Vincent Indianapolis Hospital | Indianapolis | Indiana | 46260 | United States |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242-1002 | United States |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky | 40536-0093 | United States |
| Kosair Children's Hospital | Louisville | Kentucky | 40232 | United States |
| Tulane Cancer Center Office of Clinical Research | Alexandria | Louisiana | 71315-3198 | United States |
| Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Baltimore | Maryland | 21215 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States |
| Butterworth Hospital at Spectrum Health | Grand Rapids | Michigan | 49503-2560 | United States |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | 48236 | United States |
| CCOP - Kalamazoo | Kalamazoo | Michigan | 49007-5381 | United States |
| Breslin Cancer Center at Ingham Regional Medical Center | Lansing | Michigan | 48910 | United States |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | 55404 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| University of Mississippi Cancer Clinic | Jackson | Mississippi | 39216-4505 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| Cardinal Glennon Children's Hospital | St Louis | Missouri | 63104 | United States |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St Louis | Missouri | 63110 | United States |
| CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | 89109-2306 | United States |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0002 | United States |
| Hackensack University Medical Center Cancer Center | Hackensack | New Jersey | 07601 | United States |
| Overlook Hospital | Morristown | New Jersey | 07962 | United States |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | United States |
| St. Joseph's Hospital and Medical Center | Paterson | New Jersey | 07503 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87131-5636 | United States |
| Maimonides Cancer Center at Maimonides Medical Center | Brooklyn | New York | 11219 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| NYU Cancer Institute at New York University Medical Center | New York | New York | 10016 | United States |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York | New York | 10032 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Stony Brook University Cancer Center | Stony Brook | New York | 11794-9446 | United States |
| SUNY Upstate Medical University Hospital | Syracuse | New York | 13210 | United States |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
| New York Medical College | Valhalla | New York | 10595 | United States |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599-7295 | United States |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina | 28232-2861 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
| Akron Children's Hospital | Akron | Ohio | 44308-1062 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
| Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106-5000 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205-2696 | United States |
| Dayton Children's - Dayton | Dayton | Ohio | 45404-1815 | United States |
| Medical University of Ohio Cancer Center | Toledo | Ohio | 43614 | United States |
| Tod Children's Hospital | Youngstown | Ohio | 44501 | United States |
| Oklahoma University Cancer Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Legacy Emanuel Hospital and Health Center and Children's Hospital | Portland | Oregon | 97227 | United States |
| Knight Cancer Institute at Oregon Health and Science University | Portland | Oregon | 97239-3098 | United States |
| Penn State Children's Hospital | Hershey | Pennsylvania | 17033-0850 | United States |
| St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134-1095 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| Rhode Island Hospital Comprehensive Cancer Center | Providence | Rhode Island | 02903 | United States |
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Palmetto Health South Carolina Cancer Center | Columbia | South Carolina | 29203 | United States |
| Greenville Hospital Cancer Center | Greenville | South Carolina | 29605 | United States |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | 57117-5039 | United States |
| East Tennessee Children's Hospital | Knoxville | Tennessee | 37901 | United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| Texas Tech University Health Sciences Center School of Medicine - Amarillo | Amarillo | Texas | 79106 | United States |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | United States |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | 75390 | United States |
| Cook Children's Medical Center - Fort Worth | Fort Worth | Texas | 76104 | United States |
| M. D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
| Covenant Children's Hospital | Lubbock | Texas | 79410 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78207 | United States |
| Methodist Children's Hospital of South Texas | San Antonio | Texas | 78229-3993 | United States |
| CCOP - Scott and White Hospital | Temple | Texas | 76508 | United States |
| Primary Children's Medical Center | Salt Lake City | Utah | 84113-1100 | United States |
| Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | 05401 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042-3300 | United States |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507-1971 | United States |
| Carilion Medical Center for Children at Roanoke Community Hospital | Roanoke | Virginia | 24014 | United States |
| Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington | 98105 | United States |
| Providence Cancer Center at Sacred Heart Medical Center | Spokane | Washington | 99220-2555 | United States |
| West Virginia University Health Sciences Center - Charleston | Charleston | West Virginia | 25302 | United States |
| Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | Huntington | West Virginia | 25701 | United States |
| Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown | West Virginia | 26506 | United States |
| St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54307-3508 | United States |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin | 53792-6164 | United States |
| Midwest Children's Cancer Center at Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Royal Children's Hospital | Brisbane | Queensland | 4029 | Australia |
| Princess Margaret Hospital for Children | Perth | Western Australia | 6001 | Australia |
| Children's & Women's Hospital of British Columbia | Vancouver | British Columbia | V6H 3V4 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| IWK Health Centre | Halifax | Nova Scotia | B3J 3G9 | Canada |
| McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario | L8N 3Z5 | Canada |
| Children's Hospital of Western Ontario | London | Ontario | N6A 5W9 | Canada |
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Hopital Sainte Justine | Montreal | Quebec | H3T 1C5 | Canada |
| Saskatoon Cancer Centre at the University of Saskatchewan | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Centre Hospitalier Universitaire de Quebec | Québec | G1V 4G2 | Canada |
| Starship Children's Health | Auckland | 1 | New Zealand |
| Christchurch Hospital | Christchurch | 8140 | New Zealand |
| Wellington Children's Hospital | Wellington | 6002 | New Zealand |
| San Jorge Children's Hospital | Santurce | 00912 | Puerto Rico |
| Swiss Pediatric Oncology Group Geneva | Geneva | 1205 | Switzerland |
| Swiss Pediatric Oncology Group Lausanne | Lausanne | 1011 | Switzerland |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Reduced-field Conformal Radiation Therapy | Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity. radiation therapy: Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Median | Full Range | Years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Marginal-failure Rate | Patients who do not recur as well as those with either central or distant recurrence would be treatment successes for this endpoint. Monitoring will be based on a Bayesian rule, with binomial likelihood and a Beta on the parameter p, the proportion of failures that are marginal failures. | All evaluable patients were included in this analysis (n = 84). One eligible patient was deemed to be not evaluable due to progression during treatment, and was excluded from the analysis per protocol. | Posted | Number | percentage of failure rate | Up to 5 years |
|
|
| ||||||||||||||||||||||||||
| Secondary | Progression-free Survival Probability | To estimate the progression-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation. | All eligible patients were included in the analysis, per protocol. | Posted | Number | 95% Confidence Interval | Percentage 3-year PFS rate | 3 years |
|
| ||||||||||||||||||||||||||
| Secondary | Event-free Survival Probability | To estimate the event-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation | All eligible patients were included in the analysis, per protocol. | Posted | Number | 95% Confidence Interval | Percentage 3-year EFS rate | 3 years |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival Probability | To estimate the overall survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation. | All eligible patients were included in the analysis, per protocol. | Posted | Number | 95% Confidence Interval | Percentage 3-year OS rate | 3 years |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life (QOL) | QOL accessed using the Behavior Assessment System for Children (BASC), the Adaptive Behavior Assessment System (ABAS), the Behavior Rating Inventory of Executive Function (BRIEF), and the Symptom Checklist-90-R (SCL-90-R). | The QOL assessments were removed from the protocol as part of Amendment #1A (as of 10/27/2010) due to extremely low compliance. No QOL data were available for statistical analysis. | Posted | Up to 5 years |
|
| |||||||||||||||||||||||||||||
| Secondary | MIB-1 Labeling Index Using Immunohistochemical Techniques With the MIB-1 Antibody According to Established Methods | The MIB-1 labeling Index will be calculated as the percentage of tumor nuclei that are immunoreactive. | All eligible patients with MIB-1 labeling index available. | Posted | Number | 95% Confidence Interval | percentage of tumor nuclei | At baseline |
|
| ||||||||||||||||||||||||||
| Secondary | Correlation MIB-1 Labeling Index With PFS | The primary methods of analysis will be via stratified Cox regression | All eligible patients with MIB-1 data available were included in this analysis. Per protocol, patients were stratified by age and tumor location. Based on a predefined cutoff, patients were categorized as MIB high or low (high: >= 2; low: < 2). The hazard ratio below is for patients with MIB high (low is the reference level). | Posted | Number | 95% Confidence Interval | Hazard ratio | Up to 10 years |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reduced-field Conformal Radiation Therapy | Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity. radiation therapy: Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT | 5 | 85 | 5 | 85 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Periorbital edema | Eye disorders |
| |||
| Anemia | Blood and lymphatic system disorders |
| |||
| Hypernatremia | Metabolism and nutrition disorders |
| |||
| Hypokalemia | Metabolism and nutrition disorders |
| |||
| Hyponatremia | Metabolism and nutrition disorders |
| |||
| Back pain | Musculoskeletal and connective tissue disorders |
| |||
| Abducens nerve disorder | Nervous system disorders |
| |||
| Encephalopathy | Nervous system disorders |
| |||
| Hydrocephalus | Nervous system disorders |
| |||
| Nervous system disorders - Other, specify | Nervous system disorders |
| |||
| Neuralgia | Nervous system disorders |
| |||
| Oculomotor nerve disorder | Nervous system disorders |
| |||
| Peripheral sensory neuropathy | Nervous system disorders |
| |||
| Tremor | Nervous system disorders |
| |||
| Trigeminal nerve disorder | Nervous system disorders |
| |||
| Depression | Psychiatric disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders |
|
Must obtain prior Sponsor approval.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Results Reporting Coordinator | Children's Oncology Group | 626-447-0064 | resultsreportingcoordinator@childrensoncologygroup.org |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009837 | Oligodendroglioma |
| D001254 | Astrocytoma |
| D020339 | Optic Nerve Glioma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| 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 |
| D019574 | Optic Nerve Neoplasms |
| D003390 | Cranial Nerve Neoplasms |
| D010524 | Peripheral Nervous System Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009901 | Optic Nerve Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D020266 | Radiotherapy, Conformal |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D011881 | Radiotherapy, Computer-Assisted |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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