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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00134030
Registration number
NCT00134030
Ethics application status
Date submitted
22/08/2005
Date registered
24/08/2005
Date last updated
7/06/2023
Titles & IDs
Public title
Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma
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Scientific title
A Randomized Trial of the European and American Osteosarcoma Study Group to Optimize Treatment Strategies for Resectable Osteosarcoma Based on Histological Response to Pre-operative Chemotherapy
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Secondary ID [1]
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NCI-2009-01066
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Secondary ID [2]
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AOST0331/ EURAMOS-1
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Universal Trial Number (UTN)
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Trial acronym
EURAMOS-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Localized Osteosarcoma
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Metastatic Osteosarcoma
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Condition category
Condition code
Cancer
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Bone
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Cancer
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Sarcoma (also see 'Bone') - soft tissue
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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: Drugs - Cisplatin
Treatment: Drugs - Doxorubicin Hydrochloride
Treatment: Drugs - Etoposide
Treatment: Drugs - Ifosfamide
Treatment: Drugs - Methotrexate
Treatment: Other - Peginterferon Alfa-2b
Other interventions - Quality-of-Life Assessment
Other interventions - Questionnaire Administration
Treatment: Surgery - Therapeutic Conventional Surgery
Active comparator: Maintenance therapy group 1 arm I - Patients receive doxorubicin IV continuously over 48 hours on days 1-2 in weeks 12, 17, 22, and 26 and cisplatin IV over 4 hours on days 1 and 2 in weeks 12 and 17. Patients also receive high-dose MTX IV over 4 hours on day 1 in weeks 15, 16, 20, 21, 24, 25, 28, and 29.
Experimental: Maintenance therapy group 1 arm II - Patients receive doxorubicin, cisplatin, and high-dose MTX as in arm I. Patients than receive PEG-interferon alfa-2b subcutaneously once daily on day 1 in weeks 30-104.
Active comparator: Maintenance therapy group 2 arm I - Patients receive doxorubicin, cisplatin, and high-dose MTX as in group 1 arm I.
Experimental: Maintenance therapy group 2 arm II - Patients receive doxorubicin IV continuously over 48 hours on days 1-2 in weeks 12, 20, 28, and 36 and cisplatin IV over 4 hours on days 1 and 2 in weeks 12 and 28. Patients also receive high-dose MTX IV over 4 hours on day 1 in weeks 15, 19, 23, 27, 31, 35, 39, and 40. Patients receive ifosfamide IV over 4 hours on days 1-5 in weeks 16, 24, and 32 and on days 1-3 in weeks 20 and 36 and etoposide IV over 1 hour on days 1-5 in weeks 16, 24, and 32.
Treatment: Drugs: Cisplatin
Given IV
Treatment: Drugs: Doxorubicin Hydrochloride
Given IV
Treatment: Drugs: Etoposide
Given IV
Treatment: Drugs: Ifosfamide
Given IV
Treatment: Drugs: Methotrexate
Given IV
Treatment: Other: Peginterferon Alfa-2b
Given subcutaneously
Other interventions: Quality-of-Life Assessment
Ancillary studies
Other interventions: Questionnaire Administration
Ancillary studies
Treatment: Surgery: Therapeutic Conventional Surgery
Undergo amputation or limb salvage surgery
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Intervention code [1]
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Treatment: Drugs
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Treatment: Other
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Other interventions
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Intervention code [4]
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Treatment: Surgery
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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 (EFS)
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Assessment method [1]
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EFS is defined as time from randomisation to the first of: death, detection of local recurrence or metastasis, progression of metastatic disease, or detection of a secondary malignancy.
EFS will be assessed using the logrank test and expressed using hazard ratios with appropriate confidence intervals. Follow up per participant will be assessed for up to 10 years. The 3 year EFS is provided as a summary.
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Timepoint [1]
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From date of randomization to date of the event.
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Secondary outcome [1]
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Percentage of Patients With Overall Survival
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Assessment method [1]
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Overall survival is time from randomization until death from any cause.
Will be assessed using the logrank test and expressed using hazard ratios with appropriate confidence intervals. Participants will be assessed for up to 10 years. 5 year overall survival is provided as a summary.
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Timepoint [1]
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From date of randomization to date of death.
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Secondary outcome [2]
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Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0
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Assessment method [2]
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Percentages of patients experiencing grade 3 and 4 adverse events. These will be compared using chi-square tests or Fisher's exact tests where appropriate.
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Timepoint [2]
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Adverse events are assessed for up to 10 years per participant.
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Eligibility
Key inclusion criteria
* Histologically confirmed high-grade osteosarcoma, including second malignancies
* Localized or metastatic disease
* The primary tumor must be located in the limbs or axial skeleton, including any of the following sites*:
* Long bone of upper limb
* Short bone of upper limb
* Long bone of lower limb
* Short bone of lower limb
* Vertebral column
* Ribs, sternum, clavicle, or scapula
* Pelvic bones, sacrum, or coccyx
* Tumor (primary, metastatic, or both) resectable OR is expected to become resectable after neoadjuvant induction chemotherapy
* Suitable for neoadjuvant chemotherapy
* Performance status - Lansky 50-100% (for patients under 16 years of age)
* Performance status - Karnofsky 50-100%*
* Performance status - WHO or ECOG 0-2*
* Platelet count = 100,000/mm³
* Neutrophil count = 1,500/mm³
* WBC = 3,000/mm³
* Bilirubin = 1.5 times upper limit of normal
* Creatinine clearance = 70 mL/min
* Creatinine based on age as follows:
* No greater than 1.0 mg/dL (for patients 5 to 10 years of age)
* No greater than 1.2 mg/dL (for patients 11 to 15 years of age)
* No greater than 1.5 mg/dL (for patients over 15 years of age)
* Ejection fraction = 50% by radionuclide angiogram
* Shortening fraction = 28% by echocardiogram
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known HIV positivity
* No prior chemotherapy for any disease
* Prior radiotherapy for another malignancy allowed
* No prior treatment for osteosarcoma
* No patients with any of the following:
* Craniofacial osteosarcoma
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Minimum age
5
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Maximum age
40
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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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Type of endpoint/s
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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
14/11/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
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Actual
30/09/2022
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Sample size
Target
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Accrual to date
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Final
1334
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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John Hunter Children's Hospital - Newcastle
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The Children's Hospital at Westmead - Westmead
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Westmead Hospital - Westmead
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Royal Brisbane and Women's Hospital - Herston
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Royal Children's Hospital-Brisbane - Herston
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Queensland Children's Hospital - South Brisbane
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Women's and Children's Hospital-Adelaide - North Adelaide
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Royal Children's Hospital - Parkville
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Recruitment hospital [9]
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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2310 - Newcastle
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2145 - Westmead
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4029 - Herston
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4101 - South Brisbane
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5006 - North Adelaide
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3052 - Parkville
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Recruitment postcode(s) [7]
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6008 - Perth
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Recruitment outside Australia
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Alabama
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Geneva
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Lausanne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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National Cancer Institute (NCI)
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Other
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University College, London
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Medical Research Council
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Ethics approval
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Summary
Brief summary
This randomized phase III trial is studying combination chemotherapy followed by surgery and two different combination chemotherapy regimens with or without PEG-interferon alfa-2b to compare how well they work in treating patients with osteosarcoma. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Biological therapies, such as PEG-interferon alfa-2b, may interfere with the growth of tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so it can be removed. Giving combination chemotherapy together with PEG-interferon alfa-2b after surgery may kill any remaining tumor cells. It is not yet known whether giving combination therapy together with PEG-interferon alfa-2b is more effective than two different combination chemotherapy regimens alone after surgery in treating osteosarcoma.
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Trial website
https://clinicaltrials.gov/study/NCT00134030
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Trial related presentations / publications
Hazewinkel AD, Lancia C, Anninga J, van de Sande M, Whelan J, Gelderblom H, Fiocco M. Disease progression in osteosarcoma: a multistate model for the EURAMOS-1 (European and American Osteosarcoma Study) randomised clinical trial. BMJ Open. 2022 Mar 4;12(3):e053083. doi: 10.1136/bmjopen-2021-053083. Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. Marina NM, Smeland S, Bielack SS, Bernstein M, Jovic G, Krailo MD, Hook JM, Arndt C, van den Berg H, Brennan B, Brichard B, Brown KLB, Butterfass-Bahloul T, Calaminus G, Daldrup-Link HE, Eriksson M, Gebhardt MC, Gelderblom H, Gerss J, Goldsby R, Goorin A, Gorlick R, Grier HE, Hale JP, Hall KS, Hardes J, Hawkins DS, Helmke K, Hogendoorn PCW, Isakoff MS, Janeway KA, Jurgens H, Kager L, Kuhne T, Lau CC, Leavey PJ, Lessnick SL, Mascarenhas L, Meyers PA, Mottl H, Nathrath M, Papai Z, Randall RL, Reichardt P, Renard M, Safwat AA, Schwartz CL, Stevens MCG, Strauss SJ, Teot L, Werner M, Sydes MR, Whelan JS. Comparison of MAPIE versus MAP in patients with a poor response to preoperative chemotherapy for newly diagnosed high-grade osteosarcoma (EURAMOS-1): an open-label, international, randomised controlled trial. Lancet Oncol. 2016 Oct;17(10):1396-1408. doi: 10.1016/S1470-2045(16)30214-5. Epub 2016 Aug 25. Whelan JS, Bielack SS, Marina N, Smeland S, Jovic G, Hook JM, Krailo M, Anninga J, Butterfass-Bahloul T, Bohling T, Calaminus G, Capra M, Deffenbaugh C, Dhooge C, Eriksson M, Flanagan AM, Gelderblom H, Goorin A, Gorlick R, Gosheger G, Grimer RJ, Hall KS, Helmke K, Hogendoorn PC, Jundt G, Kager L, Kuehne T, Lau CC, Letson GD, Meyer J, Meyers PA, Morris C, Mottl H, Nadel H, Nagarajan R, Randall RL, Schomberg P, Schwarz R, Teot LA, Sydes MR, Bernstein M; EURAMOS collaborators. EURAMOS-1, an international randomised study for osteosarcoma: results from pre-randomisation treatment. Ann Oncol. 2015 Feb;26(2):407-14. doi: 10.1093/annonc/mdu526. Epub 2014 Nov 24.
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Public notes
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Contacts
Principal investigator
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Neyssa M Marina
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Children's Oncology Group
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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
Type
Other Details
Attachment
Study protocol
Study Protocol, Statistical Analysis Plan, and Inf...
[
More Details
]
https://cdn.clinicaltrials.gov/large-docs/30/NCT00134030/Prot_SAP_ICF_000.pdf
Statistical analysis plan
Study Protocol, Statistical Analysis Plan, and Inf...
[
More Details
]
https://cdn.clinicaltrials.gov/large-docs/30/NCT00134030/Prot_SAP_ICF_000.pdf
Informed consent form
Study Protocol, Statistical Analysis Plan, and Inf...
[
More Details
]
https://cdn.clinicaltrials.gov/large-docs/30/NCT00134030/Prot_SAP_ICF_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00134030
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