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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000257664 | Other Identifier | Clinical Trials.gov | |
| COG-ACNS0122 | Other Identifier | Children's Oncology Group |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it is no longer present by conventional imaging and tumor markers from serum and cerebrospinal fluid. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Combining different types of therapy may kill more tumor cells.
PURPOSE: This Phase II trial is studying how well neoadjuvant chemotherapy with or without surgery and with or without high dose chemotherapy and peripheral stem cell transplantation, can increase response rates prior to radiation therapy and increase progression free and overall surviving patients with newly diagnosed intracranial germ cell tumors.
OBJECTIVES:
OUTLINE:
Induction chemotherapy:
Patients undergo re-evaluation. Patients with a complete response (CR) go directly to radiotherapy. Approximately 3 weeks after completion of induction chemotherapy, all patients with less than a CR are encouraged to undergo second-look surgery.
After second-look surgery, patients with a CR or a partial response (PR) go directly to radiotherapy. Patients with less than a PR undergo consolidation chemotherapy with peripheral blood stem cell rescue (PBSC) followed by radiotherapy.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 80-100 patients will be accrued for this study within 36-42 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation Therapy (CR from Induction) | Experimental | Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Response to Induction Chemotherapy | A patient who achieves a complete or partial response, defined a reduction of at least 65% in tumor size after induction chemotherapy will be considered to have experienced response. | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Probability of Event-free Survival (EFS) | Event-free Survival was defined as time from study entry to death from any cause, disease progression or recurrence, or second malignant neoplasm. Event-free survival was estimated by KM estimate. | At 3 years from study entry |
| Progression-free Survival (PFS) |
Not provided
DISEASE CHARACTERISTICS:
One of the following diagnoses:
Histologically confirmed intracranial non-germinomatous germ cell tumor (NGGCT) of 1 of the following types:
Histologically confirmed germinoma with elevation of serum/CSF beta human chorionic gonadotropin (HCG) levels greater than 50 mIU/mL or any serum/CSF alpha-fetoprotein (AFP) levels greater than 10 ng/ml or above institutional norm
Histologically unconfirmed pineal and/or suprasellar tumors with serum/CSF beta HCG levels greater than 50 mIU/mL or AFP levels greater than 10 ng/ml or above institutional norm
Patients with normal AFP and beta HCG < 50 mIU/mL without histologic diagnosis of a NGGCT or patients with pure germinoma without elevation of tumor marker are ineligible
Initial diagnosis within the past 31 days
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Stewart Goldman, MD | Ann & Robert H Lurie Children's Hospital of Chicago | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Birmingham | Alabama | 35294 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31545689 | Derived | Fangusaro J, Wu S, MacDonald S, Murphy E, Shaw D, Bartels U, Khatua S, Souweidane M, Lu HM, Morris D, Panigrahy A, Onar-Thomas A, Fouladi M, Gajjar A, Dhall G. Phase II Trial of Response-Based Radiation Therapy for Patients With Localized CNS Nongerminomatous Germ Cell Tumors: A Children's Oncology Group Study. J Clin Oncol. 2019 Dec 1;37(34):3283-3290. doi: 10.1200/JCO.19.00701. Epub 2019 Sep 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiation Therapy (CR From Induction) | Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy. carboplatin: Given IV etoposide: Given IV ifosfamide: Given IV radiation therapy: craniospinal irradiation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| etoposide | Drug | Given IV |
|
|
| ifosfamide | Drug | Given IV |
|
|
| thiotepa | Drug | Given IV |
|
|
| adjuvant therapy | Procedure |
|
| conventional surgery | Procedure |
|
| neoadjuvant therapy | Procedure |
|
| peripheral blood stem cell transplantation | Procedure |
|
| radiation therapy | Radiation | craniospinal irradiation |
|
|
Progression-free Survival was defined as time from study entry to disease progression or recurrence. Deaths that are clearly unrelated to disease progression, and second neoplasms are censored in this analysis. Progression -free survival was estimated by KM estimate. |
| At 3 years from study entry |
| Overall Survival (OS) | Overall Survival was defined as time from study entry to death from any cause. Overall survival was estimated by KM estimate. | At 3 years from study entry |
| Number of Patients Experiencing Toxic Death | Toxic death, defined as death predominantly attributable to treatment-related causes. | During chemotherapy (up to 18 weeks) |
| Occurrence of Non-hematological Grade 4 Toxicity Occurrence of Nonhematological Grade 4 Toxicity | The number of patients who experienced non-hematological grade 4 toxicities anytime during chemotherapy. | During chemotherapy(up to 18 weeks) |
| Phoenix Children's Hospital |
| 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 | 90242-2814 | 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 |
| 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 |
| Sutter Cancer Center | Sacramento | California | 95816 | 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 |
| Stanford Cancer Center | Stanford | California | 94305-5824 | United States |
| Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Farmington | Connecticut | 06360-2875 | United States |
| Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010-2970 | United States |
| Lee Cancer Care of Lee Memorial Health System | Fort Myers | Florida | 33901 | United States |
| University of Florida Shands Cancer Center | Gainesville | Florida | 32610-0232 | 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 |
| 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 |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | United States |
| MBCCOP - Medical College of Georgia Cancer Center | Augusta | Georgia | 30912-3730 | United States |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Advocate Lutheran General Cancer Care Center | Park Ridge | Illinois | 60068-1174 | 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 |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas | 66160-7357 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
| Floating Hospital for Children at Tufts - New England Medical Center | Boston | Massachusetts | 02111 | United States |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | 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 |
| 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 |
| Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | 55455 | 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 |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St Louis | Missouri | 63110 | United States |
| Hackensack University Medical Center Cancer Center | Hackensack | New Jersey | 07601 | United States |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | 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 |
| 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 |
| 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 |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina | 28232-2861 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Akron Children's Hospital | Akron | Ohio | 44308-1062 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205-2696 | United States |
| Children's Medical Center - Dayton | Dayton | Ohio | 45404-1815 | United States |
| Oklahoma University Cancer Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Oregon Health and Science University Cancer Institute | Portland | Oregon | 97239-3098 | United States |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104-9786 | United States |
| St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134-1095 | United States |
| Children's Hospital of Pittsburgh | 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 |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | 57117-5039 | United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | 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 |
| 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 |
| Primary Children's Medical Center | Salt Lake City | Utah | 84113-1100 | United States |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507-1971 | United States |
| West Virginia University Health Sciences Center - Charleston | Charleston | West Virginia | 25302 | United States |
| St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54307-3508 | United States |
| Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin | 54449 | United States |
| Midwest Children's Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Royal Children's Hospital | Brisbane | Queensland | 4029 | Australia |
| Royal Children's Hospital | Parkville | Victoria | 3052 | 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 |
| Janeway Children's Health and Rehabilitation Centre | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario | L8N 3Z5 | Canada |
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Montreal Children's Hospital at McGill University Health Center | Montreal | Quebec | H3H 1P3 | 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 | New Zealand |
| Swiss Pediatric Oncology Group Bern | Bern | 3010 | Switzerland |
| Swiss Pediatric Oncology Group Geneva | Geneva | 1205 | Switzerland |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Radiation Therapy (CR From Induction) | Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy. carboplatin: Given IV etoposide: Given IV ifosfamide: Given IV radiation therapy: craniospinal irradiation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | 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 | Response to Induction Chemotherapy | A patient who achieves a complete or partial response, defined a reduction of at least 65% in tumor size after induction chemotherapy will be considered to have experienced response. | Of the 102 eligible patients, 85 completed induction chemotherapy with sufficient data to assess response. Central review response assessment is used. | Posted | Count of Participants | Participants | 18 weeks |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | The Probability of Event-free Survival (EFS) | Event-free Survival was defined as time from study entry to death from any cause, disease progression or recurrence, or second malignant neoplasm. Event-free survival was estimated by KM estimate. | Two ineligible patients were excluded. A total of 102 eligible patients were analyzed. | Posted | Number | 95% Confidence Interval | Probability | At 3 years from study entry |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | Progression-free Survival was defined as time from study entry to disease progression or recurrence. Deaths that are clearly unrelated to disease progression, and second neoplasms are censored in this analysis. Progression -free survival was estimated by KM estimate. | Two ineligible patients were excluded. A total of 102 eligible patients were analyzed. one patient died without the disease progression reported. But the death was due to the disease. The death was counted as "event" when progression-free survival (PFS) was calculated. So EFS and PFS at 3 years were same. | Posted | Number | 95% Confidence Interval | Probability | At 3 years from study entry |
| ||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall Survival was defined as time from study entry to death from any cause. Overall survival was estimated by KM estimate. | Two ineligible patients were excluded. A total of 102 eligible patients were analyzed. | Posted | Number | 95% Confidence Interval | Probability | At 3 years from study entry |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Experiencing Toxic Death | Toxic death, defined as death predominantly attributable to treatment-related causes. | A total of 102 eligible patients treated with induction chemotherapy were included. | Posted | Count of Participants | Participants | During chemotherapy (up to 18 weeks) |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Occurrence of Non-hematological Grade 4 Toxicity Occurrence of Nonhematological Grade 4 Toxicity | The number of patients who experienced non-hematological grade 4 toxicities anytime during chemotherapy. | A total of 102 eligible patients treated with induction chemotherapy were included. | Posted | Number | 95% Confidence Interval | participants | During chemotherapy(up to 18 weeks) |
|
|
Not provided
104 patients enrolled, 2 are ineligible and not included in adverse event reporting. Therefore, adverse events participants reported is 102.
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 | Radiation Therapy (CR From Induction) | Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy. carboplatin: Given IV etoposide: Given IV ifosfamide: Given IV radiation therapy: craniospinal irradiation | 8 | 102 | 70 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Lymphocyte count decreased | Investigations |
| |||
| Neutrophil count decreased | Investigations |
| |||
| Platelet count decreased | Investigations |
| |||
| White blood cell decreased | Investigations |
| |||
| Hyperkalemia | Metabolism and nutrition disorders |
| |||
| Hypernatremia | Metabolism and nutrition disorders |
| |||
| Hypokalemia | Metabolism and nutrition disorders |
| |||
| Hypophosphatemia | Metabolism and nutrition disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Seizure | Nervous system disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders |
| |||
| Febrile neutropenia | Blood and lymphatic system disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Infections and infestations - Other, specify | Infections and infestations |
| |||
| Alanine aminotransferase increased | Investigations |
| |||
| Aspartate aminotransferase increased | Investigations |
| |||
| Lymphocyte count decreased | Investigations |
| |||
| Neutrophil count decreased | Investigations |
| |||
| Platelet count decreased | Investigations |
| |||
| White blood cell decreased | Investigations |
| |||
| Hyperglycemia | Metabolism and nutrition disorders |
| |||
| Hyperkalemia | Metabolism and nutrition disorders |
| |||
| Hypermagnesemia | Metabolism and nutrition disorders |
| |||
| Hypernatremia | Metabolism and nutrition disorders |
| |||
| Hypoalbuminemia | Metabolism and nutrition disorders |
| |||
| Hypocalcemia | Metabolism and nutrition disorders |
| |||
| Hypokalemia | Metabolism and nutrition disorders |
| |||
| Hypomagnesemia | Metabolism and nutrition disorders |
| |||
| Hyponatremia | Metabolism and nutrition disorders |
| |||
| Hypophosphatemia | Metabolism and nutrition disorders |
| |||
| Headache | Nervous system disorders |
|
Must obtain prior Sponsor approval.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Results Reporting Coordinator | Children's Oncology Group | 352-273-0558 | Resultsreportingcoordinator@childrensoncologygroup.org |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D013724 | Teratoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D005047 | Etoposide |
| C061400 | etoposide phosphate |
| D007069 | Ifosfamide |
| D013852 | Thiotepa |
| D017024 | Chemotherapy, Adjuvant |
| D020360 | Neoadjuvant Therapy |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D011878 | Radiotherapy |
| D061888 | Craniospinal Irradiation |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Unknown or Not Reported |
|
| Australia |
|
| New Zealand |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|