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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-02611 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| S12-01231 | |||
| CDR0000687639 | |||
| COG-AEWS1031 | |||
| AEWS1031 | Other Identifier | Children's Oncology Group | |
| AEWS1031 | Other Identifier | CTEP | |
| P30CA013330 | U.S. NIH Grant/Contract | View source | |
| U10CA098543 | U.S. NIH Grant/Contract | View source | |
| U10CA180830 | U.S. NIH Grant/Contract | View source | |
| U10CA180886 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial examined the outcome benefit to patients of adding a new chemotherapy drug combination to the established treatment approach for patients with extracranial Ewing sarcoma, that had not spread from the primary site to other places in the body. The trial randomly assigned patients at the time of study entry to receive established standard treatment with the following 5-drugs: vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide and etoposide. The outcome for patients receiving the standard 5-drug combination was compared to the outcome for patients who received the same 5-drugs with an additional drug, topotecan hydrochloride delivered in a novel combination with vincristine sulfate and cyclophosphamide.
PRIMARY OBJECTIVES:
l. Test the effect of the combination of vincristine (vincristine sulfate), cyclophosphamide, and topotecan (topotecan hydrochloride) (VTC) added to the standard 5-drug interval-compressed chemotherapy backbone on event-free and overall survival of children and young adults with Ewing sarcoma.
CORRELATIVE SCIENCE OBJECTIVES:
I. To evaluate initial volumetric tumor size as a prognostic factor for event free survival (EFS) in patients with localized Ewing tumors.
II. To evaluate histologic response as a prognostic factor for EFS in patients with localized Ewing tumors.
III. To continue evaluation of biologic markers both as related to prognosis and as eventual therapeutic targets via encouraging concurrent enrollment on a Ewing sarcoma specimen-collection study.
IV. To evaluate imaging response by fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) as a prognostic factor for EFS.
V. To evaluate the effects of the type of local therapy on EFS and overall survival.
VI. To evaluate the effect of local surgical margins in conjunction with histologic response on EFS in patients with localized Ewing tumors.
VII. To evaluate the effect of local therapy modality (surgery, radiotherapy, or a combination) as well as the type of surgical reconstruction on musculoskeletal complications.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A:
INDUCTION THERAPY: Patients receive vincristine sulfate intravenously (IV) on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV over 1-15 minutes (or as per institutional policies up to 60-minutes) on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11.
CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7, 8, 9, 10, 13, 14, 17, 18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 1 and 9.
ARM B:
INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-30 minutes on days 1-5 in weeks 1 and 9, and over 30-60 minutes on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm A; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11.
CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and over 30-60 minutes on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1- 2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9,13, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 13 and 19.
Patients could undergo surgery alone after recovery from week 12 chemotherapy if the primary tumor could be completely resected with negative margins and with reasonable functional result. Patients with inadequate margins after surgery were to receive radiotherapy in addition. Patients with lesions in surgically difficult sites such as the spine, skull, and periacetabular pelvis, patients with a poor response to induction chemotherapy, or those patients in whom surgery would result in unacceptable functional results were recommended to receive radiation and not surgery. Radiotherapy was to be administered during weeks 1-7 of consolidation therapy or after recovery from surgery for patients with positive margins. Patients who received planned pre-operative radiation and had positive surgical margins were to receive additional radiotherapy.
After completion of study therapy, patients are followed up every 3 months for 3 years and then every 6 months for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (combination chemotherapy) | Experimental | INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV over 1-15 minutes (or as per institutional policies up to 60-minutes) on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7, 8, 9, 10, 13, 14, 17, 18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 1 and 9. |
|
| Arm B (combination chemotherapy, topotecan hydrochloride) | Experimental | INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-30 minutes on days 1-5 in weeks 1 and 9, and over 30-60 minutes on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm A; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and over 30-60 minutes on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1- 2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9,13, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 13 and 19. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-Free Survival | Estimated 5-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact. | 5 years after enrollment |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Time from study enrollment to death or last patient contact. | 5 years after enrollment |
| Histological Response, in Terms of Event Free Survival After Local Control in Patients Who Received Local Control Therapy |
Inclusion Criteria:
Patients with newly diagnosed, biopsy confirmed, extracranial, non-metastatic Ewing sarcoma or primitive neuroectodermal tumor (PNET) of bone or soft tissue are eligible for this study; note:
Patient eligibility will be based on a diagnosis of Ewing sarcoma or PNET by institutional pathologist
No prior chemotherapy or radiation therapy is allowed; patients should only have had a biopsy of the primary tumor without an attempt at complete or partial resection; patients will still be eligible if unplanned excision was attempted or accomplished as long as adequate imaging was obtained prior to surgery
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70mL/min/1.73 m^2 or serum creatinine based on age/gender as follows:
Total bilirubin < 1.5 x upper limit of normal (ULN) for age
Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age
Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by radionuclide angiogram
Exclusion Criteria:
Patients must have no evidence of metastatic disease; metastatic disease are lesions which are discontinuous from the primary tumor, are not regional lymph nodes and do not share a body cavity with the primary tumor; if there is any doubt whether lesions are metastatic, a biopsy of those lesions should be taken
Skeletal lesions in adjacent bones (trans-articular)
Contralateral pleural effusion and contralateral pleural nodules
Distant lymph node involvement
Patients with pulmonary nodules are considered to have metastatic disease if the patient has:
Patients whose tumors arise in the dural and intra-dural soft tissues of the cranium and spine are not eligible
Patients with pathologic diagnoses other than Ewing sarcoma will be excluded
Patients diagnosed with Ewing Sarcoma as a second malignant neoplasm are not eligible if they have received chemotherapy or radiation for the treatment of their primary malignancy
Pregnant women will not be entered on this study; pregnancy tests must be obtained in female patients who are post-menarchal; lactating females may not participate unless they have agreed not to breastfeed their infants; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of the study treatment
All patients and/or their parents or legal guardians must sign a written informed consent
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
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| Name | Affiliation | Role |
|---|---|---|
| Patrick J Leavey | Children's Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | United States | ||
| University of Alabama at Birmingham Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34652968 | Derived | Leavey PJ, Laack NN, Krailo MD, Buxton A, Randall RL, DuBois SG, Reed DR, Grier HE, Hawkins DS, Pawel B, Nadel H, Womer RB, Letson GD, Bernstein M, Brown K, Maciej A, Chuba P, Ahmed AA, Indelicato DJ, Wang D, Marina N, Gorlick R, Janeway KA, Mascarenhas L. Phase III Trial Adding Vincristine-Topotecan-Cyclophosphamide to the Initial Treatment of Patients With Nonmetastatic Ewing Sarcoma: A Children's Oncology Group Report. J Clin Oncol. 2021 Dec 20;39(36):4029-4038. doi: 10.1200/JCO.21.00358. Epub 2021 Oct 15. |
| Label | URL |
|---|---|
| Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (Combination Chemotherapy) | INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV over 1-15 minutes (or as per institutional policies up to 60-minutes) on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7, 8, 9, 10, 13, 14, 17, 18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 1 and 9. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 4, 2016 |
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| Dexrazoxane | Drug |
|
|
| Doxorubicin Hydrochloride | Drug | Given IV |
|
|
| Etoposide | Drug | Given IV |
|
|
| Ifosfamide | Drug | Given IV |
|
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Topotecan Hydrochloride | Drug | Given IV |
|
|
| Vincristine Sulfate | Drug | Given IV |
|
|
Percent of viable tumor in the resected tumor specimen after the patient receives 2 cycles of induction chemotherapy. Patients will be classified into groups according to: (1) good risk - less than 10% viable tumor in the resection specimen; and (2) standard risk - 10% or more viable tumor in the resection specimen. Patients who receive radiation therapy to the primary tumor prior to tumor resection or whose tumor is resected prior to the start of systemic therapy are not evaluable for this outcome measure.
| At the end of INDUCTION THERAPY (84 days) |
| SUVmax as Determined by Positron Emission Tomography (PET)-Determined Response at Enrollment | Patients will be classified into two groups according to SUVmax as: (1) study population median or greater; and (2) less than the study population median. | At study enrollment |
| SUVmax as Determined by Positron Emission Tomography (PET)-Determined Response After Induction | Patients will be classified into two groups according to SUVmax as: (1) study population median or greater; and (2) less than the study population median. Patients who receive radiation therapy to the primary tumor prior to the completion of 2 cycles of induction or who do not receive 2 cycles of induction chemotherapy are not evaluable for this outcome measure. | At the end of INDUCTION THERAPY (84 days) |
| Tumor Volume in Milliliters (ml) at Enrollment | Patients will be classified into two groups: (1) tumor volume 200 ml or greater and (2) tumor volume less than 200 ml. | At study enrollment |
| Radiological Response of Soft Tissue Component of Mass by Radiological Evaluation at the End of Induction Chemotherapy | Patients will be classified into two groups: (1) complete resolution of soft tissue mass; and (2) soft tissue mass present after induction chemotherapy. Patients who receive radiation therapy to the primary tumor prior to the completion of 2 cycles of induction, who do not receive 2 cycles of induction chemotherapy or who do not have soft tissue involvement detected at enrollment or at any time prior to the end of induction chemotherapy are not evaluable for this outcome measure. | At the end of INDUCTION THERAPY (84 days) |
| Type of Local Control Modality Used for Removal of Primary Tumor Site at Any Time up to the End of the First 6 Cycles of Consolidation Chemotherapy | Patients will be categorized into the following groups: (1) surgery as the local control modality; (2) radiation therapy as the local control modality; (3) surgery and radiation therapy as the local control modality; and (4) no local control modality administered to the primary tumor site. Patients who do not complete induction chemotherapy will not be evaluable for this outcome measure. | 126 days after enrollment |
| Occurrence of Grade 2 or Higher Musculoskeletal Event (ME), or Surgery Required to Treat a Complication of Local Therapy | Any National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 ME of grade 2 or greater or ME of any grade where surgery is required to treat a complication of local therapy. Patients who do not complete induction chemotherapy or do not have any local control modality administered to the primary tumor site will not be evaluable for this outcome measure. | 132 days after enrollment |
| Presence of Tumor at the Margin of Resection for Patients Who Have Surgery as the Only Local Control Modality | Patients will be categorized into the following groups: (1) tumor present at the margin of resection; and (2) no tumor present at the margin of resection. Patients who are not classified as having surgery as the only local control modality will not be evaluable for this outcome measure. | 126 days after enrollment |
| Birmingham |
| Alabama |
| 35233 |
| United States |
| USA Health Strada Patient Care Center | Mobile | Alabama | 36604 | United States |
| Providence Alaska Medical Center | Anchorage | Alaska | 99508 | United States |
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | United States |
| Banner University Medical Center - Tucson | Tucson | Arizona | 85719 | United States |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202-3591 | United States |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| Kaiser Permanente Downey Medical Center | Downey | California | 90242 | United States |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | United States |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
| Miller Children's and Women's Hospital Long Beach | Long Beach | California | 90806 | United States |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| Los Angeles General Medical Center | Los Angeles | California | 90033 | United States |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Mattel Children's Hospital UCLA | Los Angeles | California | 90095 | United States |
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
| Valley Children's Hospital | Madera | California | 93636 | United States |
| UCSF Benioff Children's Hospital Oakland | Oakland | California | 94609 | United States |
| Kaiser Permanente-Oakland | Oakland | California | 94611 | United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States |
| Lucile Packard Children's Hospital Stanford University | Palo Alto | California | 94304 | United States |
| Sutter Medical Center Sacramento | Sacramento | California | 95816 | United States |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| Rady Children's Hospital - San Diego | San Diego | California | 92123 | United States |
| UCSF Medical Center-Parnassus | San Francisco | California | 94143 | United States |
| UCSF Medical Center-Mission Bay | San Francisco | California | 94158 | United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver | Colorado | 80218 | United States |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| Yale University | New Haven | Connecticut | 06520 | United States |
| Alfred I duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Broward Health Medical Center | Fort Lauderdale | Florida | 33316 | United States |
| Lee Memorial Health System | Fort Myers | Florida | 33901 | United States |
| Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida | 33908 | United States |
| UF Health Cancer Institute - Gainesville | Gainesville | Florida | 32610 | United States |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood | Florida | 33021 | United States |
| Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | 32207 | United States |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | United States |
| Miami Cancer Institute | Miami | Florida | 33176 | United States |
| AdventHealth Orlando | Orlando | Florida | 32803 | United States |
| Arnold Palmer Hospital for Children | Orlando | Florida | 32806 | United States |
| Nemours Children's Clinic - Orlando | Orlando | Florida | 32806 | United States |
| Orlando Health Cancer Institute | Orlando | Florida | 32806 | United States |
| Nemours Children's Hospital | Orlando | Florida | 32827 | United States |
| Nemours Children's Clinic - Pensacola | Pensacola | Florida | 32504 | United States |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida | 33607 | United States |
| Saint Mary's Medical Center | West Palm Beach | Florida | 33407 | United States |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital | Atlanta | Georgia | 30329 | United States |
| Augusta University Medical Center | Augusta | Georgia | 30912 | United States |
| Memorial Health University Medical Center | Savannah | Georgia | 31404 | United States |
| Straub Clinic and Hospital | Honolulu | Hawaii | 96813 | United States |
| University of Hawaii Cancer Center | Honolulu | Hawaii | 96813 | United States |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | United States |
| Tripler Army Medical Center | Honolulu | Hawaii | 96859 | United States |
| Saint Luke's Cancer Institute - Boise | Boise | Idaho | 83712 | United States |
| Lurie Children's Hospital-Chicago | Chicago | Illinois | 60611 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Illinois | Chicago | Illinois | 60612 | United States |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Advocate Children's Hospital-Oak Lawn | Oak Lawn | Illinois | 60453 | United States |
| Advocate Children's Hospital-Park Ridge | Park Ridge | Illinois | 60068 | United States |
| Advocate Lutheran General Hospital | Park Ridge | Illinois | 60068 | United States |
| Saint Jude Midwest Affiliate | Peoria | Illinois | 61637 | United States |
| Saint John's Hospital | Springfield | Illinois | 62702 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | United States |
| Springfield Memorial Hospital | Springfield | Illinois | 62781 | United States |
| Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| Ascension Saint Vincent Indianapolis Hospital | Indianapolis | Indiana | 46260 | United States |
| Blank Children's Hospital | Des Moines | Iowa | 50309 | United States |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | United States |
| Siouxland Regional Cancer Center | Sioux City | Iowa | 51101 | United States |
| Mercy Medical Center-Sioux City | Sioux City | Iowa | 51102 | United States |
| Saint Luke's Regional Medical Center | Sioux City | Iowa | 51104 | United States |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | United States |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | United States |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | United States |
| Children's Hospital New Orleans | New Orleans | Louisiana | 70118 | United States |
| Ochsner Medical Center Jefferson | New Orleans | Louisiana | 70121 | United States |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | United States |
| Maine Children's Cancer Program | Scarborough | Maine | 04074 | United States |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | United States |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | United States |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889-5600 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| UMass Memorial Medical Center - University Campus | Worcester | Massachusetts | 01655 | United States |
| C S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | United States |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Henry Ford Health Saint John Hospital | Detroit | Michigan | 48236 | United States |
| Michigan State University | East Lansing | Michigan | 48823 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| Corewell Health Children's | Royal Oak | Michigan | 48073 | United States |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | 55404 | United States |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| University of Missouri Children's Hospital | Columbia | Missouri | 65212 | United States |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | United States |
| Children's Hospital and Medical Center of Omaha | Omaha | Nebraska | 68114 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | United States |
| Sunrise Hospital and Medical Center | Las Vegas | Nevada | 89109 | United States |
| Nevada Cancer Research Foundation NCORP | Las Vegas | Nevada | 89120 | United States |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas | Nevada | 89135 | United States |
| Summerlin Hospital Medical Center | Las Vegas | Nevada | 89144 | United States |
| Saint Mary's Regional Medical Center | Reno | Nevada | 89503 | United States |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| Saint Peter's University Hospital | New Brunswick | New Jersey | 08901 | United States |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08903 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| Saint Joseph's Regional Medical Center | Paterson | New Jersey | 07503 | United States |
| Overlook Hospital | Summit | New Jersey | 07902 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park | New York | 11040 | United States |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | United States |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | United States |
| New York Medical College | Valhalla | New York | 10595 | United States |
| Mission Hospital | Asheville | North Carolina | 28801 | United States |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | United States |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | 28204 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Sanford Broadway Medical Center | Fargo | North Dakota | 58122 | United States |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Rainbow Babies and Childrens Hospital | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Dayton Children's Hospital | Dayton | Ohio | 45404 | United States |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital | Toledo | Ohio | 43606 | United States |
| Mercy Children's Hospital | Toledo | Ohio | 43608 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Natalie Warren Bryant Cancer Center at Saint Francis | Tulsa | Oklahoma | 74136 | United States |
| Providence Saint Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Legacy Emanuel Children's Hospital | Portland | Oregon | 97227 | United States |
| Legacy Emanuel Hospital and Health Center | Portland | Oregon | 97227 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania | 18017 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Penn State Children's Hospital | Hershey | Pennsylvania | 17033 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Saint Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Prisma Health Richland Hospital | Columbia | South Carolina | 29203 | United States |
| BI-LO Charities Children's Cancer Center | Greenville | South Carolina | 29605 | United States |
| Greenville Cancer Treatment Center | Greenville | South Carolina | 29605 | United States |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | United States |
| T C Thompson Children's Hospital | Chattanooga | Tennessee | 37403 | United States |
| East Tennessee Childrens Hospital | Knoxville | Tennessee | 37916 | United States |
| Saint Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | 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 |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | United States |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | United States |
| El Paso Children's Hospital | El Paso | Texas | 79905 | United States |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | United States |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas | 77030 | United States |
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Covenant Children's Hospital | Lubbock | Texas | 79410 | United States |
| Children's Hospital of San Antonio | San Antonio | Texas | 78207 | United States |
| Methodist Children's Hospital of South Texas | San Antonio | Texas | 78229 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Scott and White Memorial Hospital | Temple | Texas | 76508 | United States |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | United States |
| University of Vermont and State Agricultural College | Burlington | Vermont | 05405 | United States |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | United States |
| Naval Medical Center - Portsmouth | Portsmouth | Virginia | 23708-2197 | United States |
| VCU Massey Comprehensive Cancer Center | Richmond | Virginia | 23298 | United States |
| Carilion Children's | Roanoke | Virginia | 24014 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| University of Washington Medical Center - Montlake | Seattle | Washington | 98195 | United States |
| Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | 99204 | United States |
| Mary Bridge Children's Hospital and Health Center | Tacoma | Washington | 98405 | United States |
| Madigan Army Medical Center | Tacoma | Washington | 98431 | United States |
| United Hospital Center | Bridgeport | West Virginia | 26330 | United States |
| West Virginia University Charleston Division | Charleston | West Virginia | 25304 | United States |
| West Virginia University Healthcare | Morgantown | West Virginia | 26506 | United States |
| Camden Clark Medical Center | Parkersburg | West Virginia | 26101 | United States |
| Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | 54301 | United States |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | United States |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| John Hunter Children's Hospital | Hunter Regional Mail Centre | New South Wales | 2310 | Australia |
| Sydney Children's Hospital | Randwick | New South Wales | 2031 | Australia |
| The Children's Hospital at Westmead | Westmead | New South Wales | 2145 | Australia |
| Royal Brisbane and Women's Hospital | Herston | Queensland | 4029 | Australia |
| Royal Children's Hospital-Brisbane | Herston | Queensland | 4029 | Australia |
| Queensland Children's Hospital | South Brisbane | Queensland | 4101 | Australia |
| Women's and Children's Hospital-Adelaide | North Adelaide | South Australia | 5006 | Australia |
| Princess Margaret Hospital for Children | Perth | Western Australia | 6008 | Australia |
| Alberta Children's Hospital | Calgary | Alberta | T3B 6A8 | Canada |
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| British Columbia Children's Hospital | Vancouver | British Columbia | V6H 3V4 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Janeway Child Health 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 |
| Kingston Health Sciences Centre | Kingston | Ontario | K7L 2V7 | Canada |
| Children's Hospital | 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 |
| The Montreal Children's Hospital of the MUHC | Montreal | Quebec | H3H 1P3 | Canada |
| Centre Hospitalier Universitaire Sainte-Justine | Montreal | Quebec | H3T 1C5 | Canada |
| Allan Blair Cancer Centre | Regina | Saskatchewan | S4T 7T1 | Canada |
| Saskatoon Cancer Centre | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) | Québec | G1V 4G2 | Canada |
| Starship Children's Hospital | Grafton | Auckland | 1145 | New Zealand |
| Christchurch Hospital | Christchurch | 8011 | New Zealand |
| San Jorge Children's Hospital | San Juan | 00912 | Puerto Rico |
| King Faisal Specialist Hospital and Research Centre | Riyadh | 11211 | Saudi Arabia |
Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive |
| FG001 | Arm B (Combination Chemotherapy, Topotecan Hydrochloride) | INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-30 minutes on days 1-5 in weeks 1 and 9, and over 30-60 minutes on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm A; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and over 30-60 minutes on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1- 2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9,13, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 13 and 19. |
|
| Received Therapy |
|
| COMPLETED | Completion of planned therapy with no event observed: disease progression, second malignant neoplasm (SMN), death regardless of cause |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (Combination Chemotherapy) | INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV over 1-15 minutes (or as per institutional policies up to 60-minutes) on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7, 8, 9, 10, 13, 14, 17, 18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 1 and 9. |
| BG001 | Arm B (Combination Chemotherapy, Topotecan Hydrochloride) | INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-30 minutes on days 1-5 in weeks 1 and 9, and over 30-60 minutes on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm A; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and over 30-60 minutes on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1- 2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9,13, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 13 and 19. |
| BG002 | Total | Total of all reporting groups |
| 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 |
| ||||||||||||||||||
| Region of Enrollment | 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 | Event-Free Survival | Estimated 5-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact. | Only eligible patients are considered in the calculation of this outcome measure. | Posted | Number | 95% Confidence Interval | Percent Probability | 5 years after enrollment |
|
|
| ||||||||||||||||||||||||||||
| Other Pre-specified | Overall Survival | Time from study enrollment to death or last patient contact. | Not Posted | 5 years after enrollment | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Histological Response, in Terms of Event Free Survival After Local Control in Patients Who Received Local Control Therapy | Percent of viable tumor in the resected tumor specimen after the patient receives 2 cycles of induction chemotherapy. Patients will be classified into groups according to: (1) good risk - less than 10% viable tumor in the resection specimen; and (2) standard risk - 10% or more viable tumor in the resection specimen. Patients who receive radiation therapy to the primary tumor prior to tumor resection or whose tumor is resected prior to the start of systemic therapy are not evaluable for this outcome measure. | Not Posted | At the end of INDUCTION THERAPY (84 days) | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | SUVmax as Determined by Positron Emission Tomography (PET)-Determined Response at Enrollment | Patients will be classified into two groups according to SUVmax as: (1) study population median or greater; and (2) less than the study population median. | Not Posted | At study enrollment | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | SUVmax as Determined by Positron Emission Tomography (PET)-Determined Response After Induction | Patients will be classified into two groups according to SUVmax as: (1) study population median or greater; and (2) less than the study population median. Patients who receive radiation therapy to the primary tumor prior to the completion of 2 cycles of induction or who do not receive 2 cycles of induction chemotherapy are not evaluable for this outcome measure. | Not Posted | At the end of INDUCTION THERAPY (84 days) | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Tumor Volume in Milliliters (ml) at Enrollment | Patients will be classified into two groups: (1) tumor volume 200 ml or greater and (2) tumor volume less than 200 ml. | Not Posted | At study enrollment | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Radiological Response of Soft Tissue Component of Mass by Radiological Evaluation at the End of Induction Chemotherapy | Patients will be classified into two groups: (1) complete resolution of soft tissue mass; and (2) soft tissue mass present after induction chemotherapy. Patients who receive radiation therapy to the primary tumor prior to the completion of 2 cycles of induction, who do not receive 2 cycles of induction chemotherapy or who do not have soft tissue involvement detected at enrollment or at any time prior to the end of induction chemotherapy are not evaluable for this outcome measure. | Not Posted | At the end of INDUCTION THERAPY (84 days) | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Type of Local Control Modality Used for Removal of Primary Tumor Site at Any Time up to the End of the First 6 Cycles of Consolidation Chemotherapy | Patients will be categorized into the following groups: (1) surgery as the local control modality; (2) radiation therapy as the local control modality; (3) surgery and radiation therapy as the local control modality; and (4) no local control modality administered to the primary tumor site. Patients who do not complete induction chemotherapy will not be evaluable for this outcome measure. | Not Posted | 126 days after enrollment | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Occurrence of Grade 2 or Higher Musculoskeletal Event (ME), or Surgery Required to Treat a Complication of Local Therapy | Any National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 ME of grade 2 or greater or ME of any grade where surgery is required to treat a complication of local therapy. Patients who do not complete induction chemotherapy or do not have any local control modality administered to the primary tumor site will not be evaluable for this outcome measure. | Not Posted | 132 days after enrollment | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Presence of Tumor at the Margin of Resection for Patients Who Have Surgery as the Only Local Control Modality | Patients will be categorized into the following groups: (1) tumor present at the margin of resection; and (2) no tumor present at the margin of resection. Patients who are not classified as having surgery as the only local control modality will not be evaluable for this outcome measure. | Not Posted | 126 days after enrollment | Participants |
Up to 6 months post-treatment planned as 252 days; All-Cause Mortality: up to 9 years
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
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 | Arm A (Combination Chemotherapy) | INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV over 1-15 minutes (or as per institutional policies up to 60-minutes) on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7, 8, 9, 10, 13, 14, 17, 18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 1 and 9. | 51 | 308 | 8 | 308 | 105 | 308 |
| EG001 | Arm B (Combination Chemotherapy, Topotecan Hydrochloride) | INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-30 minutes on days 1-5 in weeks 1 and 9, and over 30-60 minutes on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm A; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and over 30-60 minutes on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1- 2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9,13, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 13 and 19. | 42 | 318 | 11 | 318 | 91 | 318 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Heart failure | Cardiac disorders | Systematic Assessment |
| ||
| Left ventricular systolic dysfunction | Cardiac disorders | Systematic Assessment |
| ||
| Right ventricular dysfunction | Cardiac disorders | Systematic Assessment |
| ||
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Ascites | Gastrointestinal disorders | Systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Stomach pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Typhlitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hepatic failure | Hepatobiliary disorders | Systematic Assessment |
| ||
| Portal hypertension | Hepatobiliary disorders | Systematic Assessment |
| ||
| Allergic reaction | Immune system disorders | Systematic Assessment |
| ||
| Enterocolitis infectious | Infections and infestations | Systematic Assessment |
| ||
| Infections and infestations - Other, specify | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Soft tissue infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Injury, poisoning and procedural complications - Other, specify | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Blood bilirubin increased | Investigations | Systematic Assessment |
| ||
| INR increased | Investigations | Systematic Assessment |
| ||
| Lymphocyte count decreased | Investigations | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| White blood cell decreased | Investigations | Systematic Assessment |
| ||
| Soft tissue necrosis lower limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Leukemia secondary to oncology chemotherapy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Capillary leak syndrome | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Bone marrow hypocellular | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Left ventricular systolic dysfunction | Cardiac disorders | Systematic Assessment |
| ||
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Anal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cecal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Esophageal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Esophagitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | Systematic Assessment |
| ||
| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Rectal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Gait disturbance | General disorders | Systematic Assessment |
| ||
| Infusion site extravasation | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Bile duct stenosis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Portal hypertension | Hepatobiliary disorders | Systematic Assessment |
| ||
| Anorectal infection | Infections and infestations | Systematic Assessment |
| ||
| Bone infection | Infections and infestations | Systematic Assessment |
| ||
| Catheter related infection | Infections and infestations | Systematic Assessment |
| ||
| Device related infection | Infections and infestations | Systematic Assessment |
| ||
| Endocarditis infective | Infections and infestations | Systematic Assessment |
| ||
| Infections and infestations - Other, specify | Infections and infestations | Systematic Assessment |
| ||
| Lung infection | Infections and infestations | Systematic Assessment |
| ||
| Mucosal infection | Infections and infestations | Systematic Assessment |
| ||
| Otitis media | Infections and infestations | Systematic Assessment |
| ||
| Pelvic infection | Infections and infestations | Systematic Assessment |
| ||
| Pleural infection | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Skin infection | Infections and infestations | Systematic Assessment |
| ||
| Soft tissue infection | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Wound infection | Infections and infestations | Systematic Assessment |
| ||
| Dermatitis radiation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Intraoperative neurological injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Radiation recall reaction (dermatologic) | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Blood bilirubin increased | Investigations | Systematic Assessment |
| ||
| Lymphocyte count decreased | Investigations | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| Weight loss | Investigations | Systematic Assessment |
| ||
| White blood cell decreased | Investigations | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Chest wall pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Joint effusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle weakness right-sided | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal deformity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myositis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pelvic soft tissue necrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Soft tissue necrosis lower limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Trismus | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Peripheral motor neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Psychosis | Psychiatric disorders | Systematic Assessment |
| ||
| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
| ||
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | Systematic Assessment |
| ||
| Pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Perineal pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Tracheal mucositis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin ulceration | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Thromboembolic event | Vascular disorders | Systematic Assessment |
|
Must obtain prior sponsor approval
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Results Reporting Coordinator | Children's Oncology Group | 6264470064 | resultsreportingcoordinator@childrensoncologygroup.org |
| Feb 19, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D064730 | Dexrazoxane |
| D011929 | Razoxane |
| D004317 | Doxorubicin |
| D005047 | Etoposide |
| D007069 | Ifosfamide |
| D019772 | Topotecan |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D054659 | Diketopiperazines |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D010078 | Oxazines |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Australia |
|
| Canada |
|
| New Zealand |
|
| Saudi Arabia |
|