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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00006734
Registration number
NCT00006734
Ethics application status
Date submitted
6/12/2000
Date registered
27/01/2003
Date last updated
3/08/2023
Titles & IDs
Public title
Comparison of Combination Chemotherapy Regimens in Treating Patients With Ewing's Sarcoma or Neuroectodermal Tumor
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Scientific title
Trial of Chemotherapy Intensification Through Compression in Ewing's Sarcoma and Related Tumors
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Secondary ID [1]
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COG-AEWS0031
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Secondary ID [2]
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AEWS0031
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sarcoma
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Condition category
Condition code
Cancer
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Sarcoma (also see 'Bone') - soft tissue
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Cancer
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Bone
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Cancer
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Children's - Other
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - filgrastim
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Drugs - etoposide
Treatment: Drugs - ifosfamide
Treatment: Drugs - vincristine sulfate
Experimental: Regimen A - Test the hypothesis that chemotherapy given every two weeks (Regimen B) will produce higher event-free survival. Treatment will occur in two phases: Induction and Continuation, with 14 cycles of chemotherapy in all. Induction consists of the first twelve weeks (four cycles on Regimen A. The cycles alternate between vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, MESNA and ifosfamide, etoposide, MESNA. G-CSF (Filgrastim) is given between chemotherapy doses. Local control (Surgery, Radiation Therapy, or a combination) will begin on Week 13 which will be after four cycles of chemotherapy.
Experimental: Regimen B - Conventional every-three-week chemotherapy for patients with Ewing sarcoma and related tumors. Treatment will occur in two phases: Induction and Continuation, with 14 cycles of chemotherapy in all. Induction consists of the first twelve weeks six cycles on Regimen B). The cycles alternate between vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, MESNA and ifosfamide etoposide MESNA. G-CSF (Filgrastim) is given between chemotherapy doses. Local control (surgery, Radiation Therapy, or a combination) will begin on Week 13, which will be after six cycles of chemotherapy.
Treatment: Other: filgrastim
Given IV
Treatment: Drugs: cyclophosphamide
Given IV
Treatment: Drugs: doxorubicin hydrochloride
Given IV
Treatment: Drugs: etoposide
Given IV
Treatment: Drugs: ifosfamide
Given IV
Treatment: Drugs: vincristine sulfate
Given IV
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Event-free survival
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Assessment method [1]
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Assessed using a two sided log rank test of 0.05.
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Timepoint [1]
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Time from study entry until disease progression, death without progression of disease, occurrence of a second malignant neoplasm or last follow-up, whichever comes first, assessed up to 5 years
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Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:
* Histologically confirmed localized Ewing's sarcoma or peripheral primitive neuroectodermal tumor (PNET) of the bone or soft tissues
* Diagnostic biopsy of primary tumor within 30 days of study
* Paraspinal or bony skull tumors of extradural origin allowed
* No intradural soft tissue tumors
* Askin's tumor of the chest wall allowed
* Chest wall tumors with ipsilateral pleural effusions or ipsilateral pleural-based secondary tumor nodules allowed
* No contralateral pleural effusions
* No metastatic disease or distant node involvement
* One pulmonary or pleural nodule greater than 1 cm in diameter OR more than 1 nodule greater than 0.5 cm in diameter are considered pulmonary metastasis
* Solitary lung nodules of 0.5-1 cm OR multiple nodules of 0.3-0.5 cm allowed unless biopsy positive for tumor
* Light microscopic appearance (hematoxylin and eosin stained) consistent with Ewing's sarcoma or peripheral PNET
* No immunohistochemical or ultrastructural evidence of rhabdomyosarcoma
* No esthesioneuroblastoma
* Clinically or pathologically involved regional lymph nodes allowed
* No CNS involvement
PATIENT CHARACTERISTICS:
Age:
* 50 and under at diagnosis
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
Renal:
* Creatinine normal for age
* Creatinine clearance or isotope glomerular filtration rate at least 75 mL/min
Cardiovascular:
* Shortening fraction at least 28% by echocardiography OR
* Ejection fraction at least 55% by radionuclide angiogram
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other prior malignancy except skin cancer diagnosed at least 5 years ago and currently in remission
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior immunotherapy for skin cancer
* No concurrent sargramostim (GM-CSF)
* No concurrent pegfilgrastim
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy
Surgery:
* Prior complete or partial excision of primary tumor allowed
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Minimum age
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Maximum age
50
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2001
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Date of last participant enrolment
Anticipated
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Date of last data collection
Anticipated
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Actual
30/06/2023
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Sample size
Target
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Accrual to date
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Final
587
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Sydney Children's Hospital - Randwick
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Children's Hospital at Westmead - Westmead
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Royal Children's Hospital - Brisbane
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Women's and Children's Hospital - North Adelaide
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Royal Children's Hospital - Parkville
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Princess Margaret Hospital for Children - Perth
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2031 - Randwick
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2145 - Westmead
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4029 - Brisbane
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5006 - North Adelaide
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3052 - Parkville
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6001 - Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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National Cancer Institute (NCI)
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SWOG Cancer Research Network
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Ethics approval
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Summary
Brief summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which chemotherapy regimen combined with radiation therapy and/or surgery is more effective in treating Ewing's sarcoma or primitive neuroectodermal tumor. PURPOSE: Randomized phase III trial to compare the effectiveness of different chemotherapy regimens combined with radiation therapy and/or surgery in treating patients who have Ewing's sarcoma or primitive neuroectodermal tumor.
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Trial website
https://clinicaltrials.gov/study/NCT00006734
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Trial related presentations / publications
van Doorninck JA, Ji L, Schaub B, Shimada H, Wing MR, Krailo MD, Lessnick SL, Marina N, Triche TJ, Sposto R, Womer RB, Lawlor ER. Current treatment protocols have eliminated the prognostic advantage of type 1 fusions in Ewing sarcoma: a report from the Children's Oncology Group. J Clin Oncol. 2010 Apr 20;28(12):1989-94. doi: 10.1200/JCO.2009.24.5845. Epub 2010 Mar 22. Womer RB, West DC, Krailo MD, Dickman PS, Pawel BR, Grier HE, Marcus K, Sailer S, Healey JH, Dormans JP, Weiss AR. Randomized controlled trial of interval-compressed chemotherapy for the treatment of localized Ewing sarcoma: a report from the Children's Oncology Group. J Clin Oncol. 2012 Nov 20;30(33):4148-54. doi: 10.1200/JCO.2011.41.5703. Epub 2012 Oct 22. Erratum In: J Clin Oncol. 2015 Mar 1;33(7):814. doi: 10.1200/JCO.2015.61.1491. Dosage error in article text. Borinstein SC, Barkauskas DA, Krailo M, Scher D, Scher L, Schlottmann S, Kallakury B, Dickman PS, Pawel BR, West DC, Womer RB, Toretsky JA. Investigation of the insulin-like growth factor-1 signaling pathway in localized Ewing sarcoma: a report from the Children's Oncology Group. Cancer. 2011 Nov 1;117(21):4966-76. doi: 10.1002/cncr.26112. Epub 2011 Apr 8. Womer RB, West DC, Krailo MD, et al.: Randomized comparison of every-two-week v. every-three-week chemotherapy in Ewing sarcoma family tumors (ESFT). [Abstract] J Clin Oncol 26 (Suppl 15): A-10504, 2008. Mora J, Castaneda A, Perez-Jaume S, Lopez-Pousa A, Maradiegue E, Valverde C, Martin-Broto J, Garcia Del Muro X, Cruz O, Cruz J, Martinez-Trufero J, Maurel J, Vaz MA, de Alava E, de Torres C. GEIS-21: a multicentric phase II study of intensive chemotherapy including gemcitabine and docetaxel for the treatment of Ewing sarcoma of children and adults: a report from the Spanish sarcoma group (GEIS). Br J Cancer. 2017 Sep 5;117(6):767-774. doi: 10.1038/bjc.2017.252. Epub 2017 Aug 8.
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Public notes
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Contacts
Principal investigator
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Richard B. Womer, MD
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Address
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Children's Hospital of Philadelphia
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Womer RB, West DC, Krailo MD, Dickman PS, Pawel BR...
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Journal
Borinstein SC, Barkauskas DA, Krailo M, Scher D, S...
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Journal
Womer RB, West DC, Krailo MD, et al.: Randomized c...
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Results not provided in
https://clinicaltrials.gov/study/NCT00006734
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