Chemotherapy for the treatment of recurrent and primary refractory Ewing sa... | Recruiting
Chemotherapy for the treatment of r... | Recruiting
Chemotherapy for the treatment of recurrent and primary refractory Ewing sarcoma
rEECur

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Medical Conditions
  • Paediatrics, Recurrent/refractory Ewing sarcoma
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
ISRCTN36453794
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-chemotherapy-for-ewings-sarcoma-reecur
Research Details
  • To compare four chemotherapy regimens: topotecan and cyclophosphamide (TC); irinotecan and temozolomide (IT); gemcitabine and docetaxel (GD) and high-dose ifosfamide (IFOS) in relapsed Ewing sarcoma with respect to efficacy, toxicity and acceptability to patients.
Phase
Phase II/III
Study Design
Multi-Arm, Multi-Stage (MAMS), randomised phase II/III, open-label multicentre international trial
Study Type
Interventional
Intervention

At trial entry patients will be randomised to one of four chemotherapy regimens:
1. Topotecan and Cyclophosphamide (TC)
6 cycles of TC. Additional cycles may be given at the discretion of the treating clinician.

2. Irinotecan and Temozolomide (IT)
6 cycles of IT. Additional cycles may be given at the discretion of the treating clinician.

3. Gemcitabine and Docetaxel (GD)
6 cycles of GD. Additional cycles may be given at the discretion of the treating clinician.

4. High-dose Ifosfamide (IFOS)
4 cycles of IFOS.

Clinicians are encouraged to use local disease control measures where possible after four cycles of chemotherapy. Stem cell harvesting may be carried out in patients for whom high-dose therapy is planned but the first four chemotherapy cycles must be given according to the randomised regimen. Patients randomised to receive TC, IT or GD who have not progressed on treatment may continue to receive the randomised regimen for more than six cycles at the discretion of the treating physician. Myeloablative therapy may be given at the discretion of the treating physician after six cycles of TC, IT or GD, or after four cycles of IFOS.

Intervention Type
Drug
Primary Outcome Measures
    Phase II: Objective Response Rate (ORR) will be measured by cross-sectional imaging according to RECIST criteria
    Phase III: Progression-Free Survival (PFS) is defined as the time from randomisation until first event (progression, recurrence following response or death without progression or recurrence). Second malignancy is not classified as an event for progression-free survival. For those patients who do not experience event during the course of the trial, progression-free survival times will be censored at the date of their last available trial assessment.
Secondary Outcome Measures
    1. Overall Survival (OS) is defined as the time from randomisation to death, irrespective of the cause. Surviving patients will be censored at their last follow-up date. OS will only be analysed for the first randomisation for each patient (re-randomisations will not be considered). Analysis methods will be as per PFS.
    2. Adverse events and toxicity: Safety data will be summarised by arm for all treated patients using appropriate tabulations and descriptive statistics. Exploratory standard statistical tests will be performed to compare the arms.
    3. Quality of Life (QoL) will be assessed at the following time points: baseline, following chemotherapy cycle 2, following chemotherapy cycle 4 using ≥18 years: EORTC QLQ-C30 , <18 years: PedsQL™ Generic Core Scales and Multidimensional Fatigue Score
    4. Days spent in hospital while on trial treatment or due to trial treatment. The number (range) and proportion (with confidence intervals) of days in hospital will be presented for each arm and overall. Exploratory standard statistical tests will be performed to compare the arms.
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Mixed
Who Can Participate
Patient
Number of Participants
275 for phase II; 390 fpr phase III
Participant Inclusion Criteria
    1. Histologically confirmed Ewing sarcoma
    2. Disease recurrence after completion of first-line treatment
    3. Refractory disease, defined by progression during first-line treatment or within 12 weeks of its completion
    4. 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.
    5. Age 2-50 years
    6. Patient assessed as medically fit to receive cytotoxic chemotherapy
    7. Documented negative pregnancy test for female patients of childbearing potential
    8. Patient agrees to use contraception during therapy and for 12 months after last trial treatment (females) or 5 months after last trial treatment (males), where applicable
    9. Written informed consent from the patient and/or the parent/legal guardian
Participant Exclusion Criteria
    1. Conventional dose cytotoxic chemotherapy or other investigational medicinal product (IMP) within previous four weeks
    2. Myeloablative dose chemotherapy within previous 8 weeks
    3. Radiotherapy to target lesions within previous 6 weeks
    4. Pregnant or breastfeeding women
    5. Follow-up not possible due to social, geographic or psychological reasons

    Additional criteria for specific arms:
    1. Patients who have previously received one of the randomised regimens may not be randomised to receive that chemotherapy regimen again
    2. Patients with a contraindication to any IMP may be entered into the study but may not be randomised to receive an arm that contains a contraindicated IMP
    3. Patients who have received cyclophosphamide during first-line therapy may be randomised to receive the TC arm
    4. Patients who have had ifosfamide during first-line therapy may be randomised to receive the IFOS arm if they do not have pre-existing renal or other toxicity that would necessitate a dose modification. There is no requirement for a minimum time between receiving first-line ifosfamide and randomisation to IFOS as part of the rEECur trial.
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Manchester
M20 4BX
Trial Contact(s)
Primary Trial Contact
Dr Martin McCabe
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
France, Germany, Italy, Norway, Spain, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
rEECur: an international randomised controlled trial of chemotherapy for the treatment of recurrent and primary refractory Ewing sarcoma
EudraCT Number
Sorry, this information is not available
Funder(s)
  • Seventh Framework Programme
Other Study ID Numbers
vn 0.4, vd 06-Jan-2014
Sponsor(s)
University of Birmingham (UK)
Key Dates

Recruitment Start Date

01 Dec 2014

Recruitment End Date

30 Sep 2018

Trial Start Date

31 Mar 2014

Trial End Date

31 Mar 2019

Date added to source

14 Feb 2014

Date updated in source

11 Jun 2015