scholarly journals Effects of zoledronic acid versus clodronic acid on skeletal morbidity in patients with newly diagnosed multiple myeloma (MRC Myeloma IX): secondary outcomes from a randomised controlled trial

2011 ◽  
Vol 12 (8) ◽  
pp. 743-752 ◽  
Author(s):  
Gareth J Morgan ◽  
J Anthony Child ◽  
Walter M Gregory ◽  
Alex J Szubert ◽  
Kim Cocks ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Zoledronic Acid ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Newly Diagnosed ◽  
Clodronic Acid ◽  
Acid Versus ◽  
Secondary Outcomes ◽  
Randomised Controlled

scholarly journals International Randomised Controlled Trial for the Treatment of Newly Diagnosed Ewing Sarcoma Family of Tumours – EURO EWING 2012 Protocol

2019 ◽  
Author(s):  
Jennifer Anne Birmingham ◽  
Veronica Moroz ◽  
Perrine Marec-Berard ◽  
Nathalie Gaspar ◽  
Valerie Laurence ◽  
...  
Keyword(s):  
Zoledronic Acid ◽  
Randomised Controlled Trial ◽  
Local Control ◽  
Ewing Sarcoma ◽  
Actinomycin D ◽  
Controlled Trial ◽  
Primary Tumour ◽  
Newly Diagnosed ◽  
Consolidation Chemotherapy ◽  
Randomised Controlled

Abstract Background Despite multiple randomised trials in newly diagnosed Ewing sarcoma family of tumours (ESFT), over many years, and involving many international co-operative groups, the outcomes for all stages of disease have plateaued. Internationally, the standard treatment of ESFT is not defined, and there is a need to add new agents other than conventional chemotherapy to improve outcomes. This trial will compare two different induction/consolidation chemotherapy regimens vincristine, ifosfamide, doxorubicin and etoposide (VIDE) induction and vincristine, actinomycin D, ifosfamide or cyclophosphamide, or Busulfan and Mephalan (VAI/VAC/BuMel) consolidation compared with vincristine, doxorubicin, cyclophosphamide, ifosfamide and etoposide (VDC/IE) induction and ifosfamide and etoposide, vincristine and cyclophosphamide, vincristine, actinomycin D and ifosfamide, or Busulfan and Mephalan (IE/VC/VAI/ BuMel) consolidation- randomisation 1 (R1). A second randomisation (R2) will determine whether the addition of zoledronic acid to consolidation chemotherapy, as assigned at R1, is associated with improved clinical outcome. Methods EURO EWING 2012 is an international, multicentre, phase III, open-label randomised controlled trial. There are two randomisations: R1 and R2. Patients are randomised at two different time points, at entry to the trial (R1) and following local control therapy (R2). The primary outcome measure is event-free survival. The secondary outcome measures include overall survival, adverse events and toxicity, histological response of the primary tumour, response of the primary tumour, regional lymph nodes and/or metastases, and achievement of local control at the end of treatment. Discussion This study will establish which is the "standard regimen" of chemotherapy, taking into account both clinical outcomes and toxicity. This will form the chemotherapy backbone for future interventional studies where we may want to add new targeted agents. It will also determine the role of zoledronic acid, in conjunction with the separate EE2008 trial. Any trial in ESFT needs to take into account the rarity of the tumour and that international co-operation is needed to provide answers in a timely manner. Trial registration Registered with EudraCT number 2012-002107-17 on 26th February 2012. Registered with ISRCTN number 54540667 on 4th November 2013.

scholarly journals International Randomised Controlled Trial for the Treatment of Newly Diagnosed Ewing Sarcoma Family of Tumours – EURO EWING 2012

2019 ◽  
Author(s):  
Jennifer Anne Birmingham ◽  
Veronica Moroz ◽  
Perrine Marec-Berard ◽  
Nathalie Gaspar ◽  
Valerie Laurence ◽  
...  
Keyword(s):  
Zoledronic Acid ◽  
Randomised Controlled Trial ◽  
Local Control ◽  
Ewing Sarcoma ◽  
Actinomycin D ◽  
Controlled Trial ◽  
Primary Tumour ◽  
Newly Diagnosed ◽  
Consolidation Chemotherapy ◽  
Randomised Controlled

Abstract Abstract Background Despite multiple randomised trials in newly diagnosed Ewing sarcoma family of tumours (ESFT), over many years, and involving many international co-operative groups, the outcomes for all stages of disease have plateaued. Internationally, the standard treatment of ESFT is not defined, and there is a need to add new agents other than conventional chemotherapy to improve outcomes. This trial will compare two different induction/consolidation chemotherapy regimens vincristine, ifosfamide, doxorubicin and etoposide (VIDE) induction and vincristine, actinomycin D, ifosfamide or cyclophosphamide, or Busulfan and Mephalan (VAI/VAC/BuMel) consolidation compared with vincristine, doxorubicin, cyclophosphamide, ifosfamide and etoposide (VDC/IE) induction and ifosfamide and etoposide, vincristine and cyclophosphamide, vincristine, actinomycin D and ifosfamide, or Busulfan and Mephalan (IE/VC/VAI/ BuMel) consolidation- randomisation 1 (R1). A second randomisation (R2) will determine whether the addition of zoledronic acid to consolidation chemotherapy, as assigned at R1, is associated with improved clinical outcome. Methods EURO EWING 2012 is an international, multicentre, phase III, open-label randomised controlled trial. There are two randomisations: R1 and R2. Patients are randomised at two different time points, at entry to the trial (R1) and following local control therapy (R2). The primary outcome measure is event-free survival. The secondary outcome measures include overall survival, adverse events and toxicity, histological response of the primary tumour, response of the primary tumour, regional lymph nodes and/or metastases, and achievement of local control at the end of treatment. Discussion This study will establish which is the "standard regimen" of chemotherapy, taking into account both clinical outcomes and toxicity. This will form the chemotherapy backbone for future interventional studies where we may want to add new targeted agents. It will also determine the role of zoledronic acid, in conjunction with the separate EE2008 trial. Any trial in ESFT needs to take into account the rarity of the tumour and that international co-operation is needed to provide answers in a timely manner. Trial registration Registered with EudraCT number 2012-002107-17 on 26th February 2012. Registered with ISRCTN number 54540667 on 4th November 2013.

scholarly journals Effectiveness of home or hospital initiation of treatment at diagnosis for children with type 1 diabetes (DECIDE trial): a multicentre individually randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e032317 ◽  
Author(s):  
John W Gregory ◽  
Julia Townson ◽  
Sue Channon ◽  
David Cohen ◽  
Mirella Longo ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Newly Diagnosed ◽  
Home Based ◽  
Secondary Outcomes ◽  
Randomised Controlled ◽  
At Home

ObjectiveTo determine whether, in children with newly diagnosed type 1 diabetes who were not acutely unwell, management at home for initiation of insulin treatment and education of the child and family, would result in improved clinical and psychological outcomes at 2 years postdiagnosis.DesignA multicentre randomised controlled trial (January 2008/October 2013).SettingEight paediatric diabetes centres in England, Wales and Northern Ireland.Participants203 clinically well children aged under 17 years, with newly diagnosed type 1 diabetes and their carers.InterventionManagement of the initiation period from diagnosis at home, for a minimum of 3 days, to include at least six supervised injections and delivery of pragmatic educational care.Main outcome measuresPrimary outcome was glycosylated haemoglobin (HbA1c) concentration at 24 months postdiagnosis. Secondary outcomes included coping, anxiety, quality of life and use of NHS resources.Results203 children, newly diagnosed, were randomised to commence management at home (n=101) or in hospital (n=102). At the 24 month primary end point, there was one withdrawal and a follow-up rate of 194/202 (96%). Mean HbA1c in the home treatment arm was 72.1 mmol/mol and in the hospital treated arm 72.6 mmol/mol. There was a negligible difference between the mean HbA1c levels in the two arms adjusted for baseline (1.01, 95% CI 0.93 to 1.09). There were mostly no differences in secondary outcomes at 24 months, apart from better child self-esteem in the home-arm. No home-arm children were admitted to hospital during initiation and there were no adverse events at that time. The number of investigations was higher in hospital patients during the follow-up period. There were no differences in insulin regimens between the two arms.ConclusionsThere is no evidence of a difference between home-based and hospital-based initiation of care in children newly diagnosed with type 1 diabetes across relevant outcomes.Trial registration numberISRCTN78114042.

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