LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted/resubmitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12618001825246
Ethics application status
Approved
Date submitted
26/10/2018
Date registered
9/11/2018
Date last updated
23/10/2019
Date data sharing statement initially provided
9/11/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
rEECur: Chemotherapy for the treatment of recurrent and primary refractory Ewing sarcoma
Query!
Scientific title
International Randomised Controlled Trial of Chemotherapy for the Treatment of Recurrent and Primary Refractory Ewing Sarcoma
Query!
Secondary ID [1]
296438
0
RG_13-277
Query!
Secondary ID [2]
296479
0
ISRCTN36453794
Query!
Secondary ID [3]
296480
0
EudraCT Number: 2014-000259-99
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Ewing Sarcoma
310203
0
Query!
Condition category
Condition code
Cancer
308947
308947
0
0
Query!
Children's - Other
Query!
Cancer
308994
308994
0
0
Query!
Bone
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
A comparison of four widely used chemotherapy regimens for the treatment of Ewing sarcoma, a type of bone cancer, to see which is most effective and/or has the fewest side effects.
The study will be analysed in two phases (Phase II/Phase III) with the least effective treatment regimens being dropped after the 1st interim analysis/2nd interim analysis.
Topotecan and Cyclophosphamide (TC): 6 cycles of 21 days, additional cycles at clinician's discretion.
IV Infusion of Topotecan 0.75mg/m2 and Cyclophosphamide 250mg/m2 on day 1, 2, 3, 4, 5
Irinotecan and Temozolomide (IT): 6 cycles of 21 days, additional cycles at clinician's discretion.
IV infusion of Irinotecan 50mg/m2 on days 1, 2, 3, 4, 5
Temozolomide 100mg/m2 orally on days 1, 2, 3, 4, 5
Gemcitabine and Docetaxel (GD): 6 cycles of 21 days, additional cycles at clinician's discretion.
IV infusion of Gemcitabine 900mg/m2 on days 1, 8.
IV infusion of Docetaxal 8mg/m2 on day 8.
Please note - GD Arm closed in November 2018.
High dose Ifosfamide (IFOS): 4 cycles of 21 days.
IV infusion of Ifosfamide 3g/m2 on days 1, 2, 3, 4, 5
Query!
Intervention code [1]
312762
0
Treatment: Drugs
Query!
Comparator / control treatment
Participants will be randomised to one of four chemotherapy regimens in order to identify the best one for use in future treatment. All four arms are currently used as standard of care treatment options for relapsed/refractory Ewing sarcoma and will therefore be part of a four way comparison.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
307906
0
Phase II: Objective response as measured by RECIST criteria after four cycles of trial treatment.
Query!
Timepoint [1]
307906
0
The main assessment time point for the phase II study will be at baseline and after 4 cycles of chemotherapy. Additional imaging will be performed after 2 and 6 cycles of chemotherapy.
Query!
Primary outcome [2]
308002
0
Phase III: Event-free survival which is defined as the time from randomisation until the first event (progression, recurrence following response, secondary malignancy or death).
Query!
Timepoint [2]
308002
0
The outcome measure of the phase III study will be event free survival. It will be assessed at every clinic visit. The frequency and timing of clinic visits is not specified in the protocol since international practice varies.
Query!
Secondary outcome [1]
353296
0
Progression-free survival (PFS)
Query!
Timepoint [1]
353296
0
PFS will be assessed at every clinic visit
Query!
Secondary outcome [2]
353625
0
Overall survival (OS)
Query!
Timepoint [2]
353625
0
OS will be assessed at every clinic visit.
Query!
Secondary outcome [3]
353626
0
Quality of Life (QoL) QoL sub-study is designed to assess the patient's well-being during chemotherapy using a questionnaire at three specified timepoints (baseline, after 2 and 4 cycles of chemotherapy). PedsQL 4.0 and EORTC-QLQ30 Version 3.0 will be used and presented to patients and parents/guardians as applicable.
Query!
Timepoint [3]
353626
0
QoL will be assessed at baseline and after 2 and 4 cycles of chemotherapy
Query!
Secondary outcome [4]
353627
0
Adverse events and toxicity, defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Query!
Timepoint [4]
353627
0
Adverse events and toxicity will be assessed prior to the start of the next chemotherapy cycle and after the last chemotherapy cycle for cycles 1-4 (Ifosfamide regimen) and cycles 1-6 (other chemotherapy regimens)
Query!
Secondary outcome [5]
353628
0
Days spent in hospital.
The number and proportion of days in hospital will be presented for each arm and overall. Standard statistical tests will be performed to compare the arms.
Sites will provide the numerical value for days spent in hospital during each cycle in the Case Report Form.
Query!
Timepoint [5]
353628
0
Days spent in hospital following each cycle will be assessed prior to the start of the next chemotherapy cycle and after the last chemotherapy cycle for cycles 1-4 (Ifosfamide regimen) and cycles 1-6 (other chemotherapy regimens)
Query!
Eligibility
Key inclusion criteria
1. Histologically confirmed Ewing sarcoma.
2. Disease recurrence or progression after completion of first line treatment OR
Refractory disease, defined by progression during first line treatment or within 12 weeks of its completion. Disease progression will be based on Response Evaluation Criteria In Solid Tumors (RECIST). The appearance of new bone lesions on bone scan will require confirmation with cross-sectional imaging.
3. Soft tissue disease component evaluable by cross-sectional imaging. Patients with bone disease without a measurable soft tissue component or bone marrow disease only will be eligible for the study but will not contribute to the phase II primary outcome measure.
4. Age greater than or equal to 4 years and less than or equal to 50 years.
5. Patient assessed as medically fit to receive cytotoxic chemotherapy.
6. Documented negative pregnancy test for female patients of childbearing potential.
7. Patient agrees to use effective contraception during therapy and for 12 months after last trial treatment (female and male), where applicable.
8. Written informed consent from the patient and/or legal guardian
Query!
Minimum age
4
Years
Query!
Query!
Maximum age
50
Years
Query!
Query!
Gender
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Bone marrow infiltration resulting in absolute neutrophil count (ANC) less than 1.0 x 10^9/l or platelets less than 75 x 10^9/l
2. Cytotoxic chemotherapy or other investigational medicinal product (IMP) within previous two weeks.
3. Myeloablative therapy within previous eight weeks.
4.Radiotherapy to target lesion within previous six weeks.
5.Pregnant or breastfeeding women.
6.Follow-up not possible due to social, geographic or psychological reasons.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2 / Phase 3
Query!
Type of endpoint(s)
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
25/11/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
400
Query!
Accrual to date
333
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Query!
Recruitment hospital [1]
12279
0
The Chris O’Brien Lifehouse - Camperdown
Query!
Recruitment hospital [2]
12280
0
Princess Alexandra Hospital - Woolloongabba
Query!
Recruitment hospital [3]
12281
0
Peter MacCallum Cancer Centre - Melbourne
Query!
Recruitment hospital [4]
12282
0
Prince of Wales Hospital - Randwick
Query!
Recruitment hospital [5]
12283
0
The Royal Adelaide Hospital - Adelaide
Query!
Recruitment hospital [6]
12284
0
The Children's Hospital at Westmead - Westmead
Query!
Recruitment hospital [7]
12285
0
John Hunter Children's Hospital - New Lambton
Query!
Recruitment hospital [8]
12287
0
Monash Children’s Hospital - Clayton
Query!
Recruitment hospital [9]
12288
0
Perth Children's Hospital - Nedlands
Query!
Recruitment hospital [10]
12289
0
The Royal Childrens Hospital - Parkville
Query!
Recruitment hospital [11]
12290
0
Sydney Children's Hospital - Randwick
Query!
Recruitment hospital [12]
12291
0
Womens and Childrens Hospital - North Adelaide
Query!
Recruitment hospital [13]
15032
0
Queensland Children's Hospital - South Brisbane
Query!
Recruitment hospital [14]
15033
0
Sir Charles Gairdner Hospital - Nedlands
Query!
Recruitment postcode(s) [1]
24470
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
24471
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [3]
24472
0
3000 - Melbourne
Query!
Recruitment postcode(s) [4]
24473
0
2031 - Randwick
Query!
Recruitment postcode(s) [5]
24474
0
5000 - Adelaide
Query!
Recruitment postcode(s) [6]
24475
0
2145 - Westmead
Query!
Recruitment postcode(s) [7]
24476
0
2305 - New Lambton
Query!
Recruitment postcode(s) [8]
24478
0
3168 - Clayton
Query!
Recruitment postcode(s) [9]
24479
0
6009 - Nedlands
Query!
Recruitment postcode(s) [10]
24480
0
3052 - Parkville
Query!
Recruitment postcode(s) [11]
24481
0
5006 - North Adelaide
Query!
Recruitment outside Australia
Country [1]
20957
0
United Kingdom
Query!
State/province [1]
20957
0
Query!
Country [2]
20958
0
Spain
Query!
State/province [2]
20958
0
Query!
Country [3]
20959
0
Italy
Query!
State/province [3]
20959
0
Query!
Country [4]
20960
0
Norway
Query!
State/province [4]
20960
0
Query!
Country [5]
20961
0
Finland
Query!
State/province [5]
20961
0
Query!
Country [6]
20962
0
Denmark
Query!
State/province [6]
20962
0
Query!
Country [7]
20963
0
Sweden
Query!
State/province [7]
20963
0
Query!
Country [8]
20964
0
France
Query!
State/province [8]
20964
0
Query!
Country [9]
20965
0
Hungary
Query!
State/province [9]
20965
0
Query!
Country [10]
20966
0
Belgium
Query!
State/province [10]
20966
0
Query!
Country [11]
20967
0
Netherlands
Query!
State/province [11]
20967
0
Query!
Country [12]
20968
0
Czech Republic
Query!
State/province [12]
20968
0
Query!
Country [13]
20969
0
Poland
Query!
State/province [13]
20969
0
Query!
Country [14]
20970
0
Germany
Query!
State/province [14]
20970
0
Query!
Country [15]
20971
0
Switzerland
Query!
State/province [15]
20971
0
Query!
Country [16]
20972
0
New Zealand
Query!
State/province [16]
20972
0
Query!
Funding & Sponsors
Funding source category [1]
301037
0
Charities/Societies/Foundations
Query!
Name [1]
301037
0
Canteen - Australian Young Cancer Patient Clinical Trials Initiative
Query!
Address [1]
301037
0
161 Flemington Road North Melbourne VIC 3051
Query!
Country [1]
301037
0
Australia
Query!
Primary sponsor type
University
Query!
Name
University of Birmingham
Query!
Address
Cancer Research Clinical Trials Unit
Vincent Drive
Edgbaston
Birmingham B15 2TT
United Kingdom
Query!
Country
United Kingdom
Query!
Secondary sponsor category [1]
300632
0
Other Collaborative groups
Query!
Name [1]
300632
0
Australian and New Zealand Children's Haematology Oncology Group
Query!
Address [1]
300632
0
Hudson Institute of Medical Research
27-31 Wright Street
Clayton VIC 3168
Query!
Country [1]
300632
0
Australia
Query!
Other collaborator category [1]
280411
0
Other Collaborative groups
Query!
Name [1]
280411
0
Australasian Sarcoma Study Group
Query!
Address [1]
280411
0
Peter MacCallum Cancer Centre
Level 1 305 Grattan Street
Melbourne VIC 3000
Query!
Country [1]
280411
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
301791
0
Hunter New England Human Research Ethics Committee
Query!
Ethics committee address [1]
301791
0
Locked Bag No 1
New Lambton NSW 2305
Query!
Ethics committee country [1]
301791
0
Australia
Query!
Date submitted for ethics approval [1]
301791
0
30/06/2017
Query!
Approval date [1]
301791
0
17/01/2018
Query!
Ethics approval number [1]
301791
0
HREC/18/HNE/5
Query!
Ethics committee name [2]
301792
0
Child and Adolescent Health Service Human Research Ethics Committee
Query!
Ethics committee address [2]
301792
0
Perth Children's Hospital
15 Hospital Avenue
Nedlands Western Australia 6009
Query!
Ethics committee country [2]
301792
0
Australia
Query!
Date submitted for ethics approval [2]
301792
0
Query!
Approval date [2]
301792
0
11/09/2017
Query!
Ethics approval number [2]
301792
0
RGS0000000480
Query!
Summary
Brief summary
The purpose of this study is to determine which of the most commonly used chemotherapy used in recurrent and primary refractory Ewing sarcoma is most beneficial.
Who is it for?
You may be eligible for this study if you are aged 4-50 years old and have been diagnosed with relapsed or refractory Ewing sarcoma.
Study details
Participants in this trial will be randomly allocated to one of four different treatment groups. These groups include:
Before treatment starts the following routine tests will be performed:
Physical check-up including measuring height and weight
Blood tests +/- urine tests
Assessment of kidney function called a GFR.
Scans (which may include CT, PET-CT, MRI, bone scan, x-ray). The doctor will decide which type of scans needed depending on where the tumour is located.
A quality of life questionnaire will also be completed before treatment commences.
During trial treatment
While you are having chemotherapy treatment you will be carefully monitored using the same routine tests that would be used if you were having chemotherapy but were not in the trial. These routine tests will include blood +/- urine tests, scans and GFR. These tests are to ensure that you are fit to continue chemotherapy. In addition if you have had a PET-CT scan before treatment, you will have another PET-CT scan after 4 cycles of chemotherapy.
You will be asked to complete two more quality of life questionnaires, one on completion of cycle 2 and one on completion of cycle 4.
All four of the treatments in this study are those which are currently used routinely for treatment of Ewing sarcoma.
It is hoped that this research will help to determine which of the treatments is most effective in improving overall survival, side effects, tumour shrinkage, quality of life and days spent in hospital.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
88118
0
Dr Martin McCabe
Query!
Address
88118
0
The Christie Hospital
Wilmslow Road
Manchester M20 4BX
United Kingdom
Query!
Country
88118
0
United Kingdom
Query!
Phone
88118
0
+44 0 161 446 3954
Query!
Fax
88118
0
Query!
Email
88118
0
reecur@trials.bham.ac.uk
Query!
Contact person for public queries
Name
88119
0
A/Prof Marianne Phillips
Query!
Address
88119
0
Haematology and Oncology
Perth Children's Hospital
15 Hospital Ave
Nedlands Western Australia 6009
Query!
Country
88119
0
Australia
Query!
Phone
88119
0
+61 8 6456 2222
Query!
Fax
88119
0
Query!
Email
88119
0
SCHN-REECUR@health.nsw.gov.au
Query!
Contact person for scientific queries
Name
88120
0
A/Prof Marianne Phillips
Query!
Address
88120
0
Haematology and Oncology
Perth Children's Hospital
15 Hospital Ave
Nedlands Western Australia 6009
Query!
Country
88120
0
Australia
Query!
Phone
88120
0
+61 8 6456 2222
Query!
Fax
88120
0
Query!
Email
88120
0
SCHN-REECUR@health.nsw.gov.au
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Results will be presented at international conferences and published in journals.
International sponsor (University of Birmingham) will be responsible for the raw data collected during the trial.
Query!
What supporting documents are/will be available?
No other documents available
Query!
Summary results
No Results
Download to PDF