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.
- Conditions
- Recurrent and refractory Ewing sarcomaMedDRA version: 20.0Level: LLTClassification code 10015567Term: Ewing's tumor localizedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10015763Term: Extra-osseous Ewing's sarcoma NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10015566Term: Ewing's tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10015762Term: Extra-osseous Ewing's sarcoma non-metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10015569Term: Ewing's tumor recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10015761Term: Extra-osseous Ewing's sarcoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10015568Term: Ewing's tumor metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10058252Term: Ewing's tumour recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10058253Term: Ewing's tumour metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2014-000259-99-HU
- Lead Sponsor
- niversity of Birmingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 400
1. Histologically confirmed Ewing sarcoma.
2. Disease progression (during or after completion of first line treatment) or any subsequent recurrence
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 =4 years and <50 years.
5. Patient assessed as medically fit to receive cytotoxic chemotherapy.
6. Documented negative pregnancy test fr female patients of childbearing potential.
7. Patient agrees to use effective contraception during therapy and for 12 months, after last trial treatment, where applicable.
8. Written informed consent from the patient and/or legal guardian.
Are the trial subjects under 18? yes
Number of subjects for this age range: 200
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
1.Bone marrow infiltration resulting in absolute neutrophil count (ANC) < 1.0 x 109/l or platelets <75 x 109/l
2.Cytotoxic chemotherapy or other investigational medicinal product (IMP) within previosu 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.
7.Previous randomisation into the rEECur trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objectives of the study are to compare four chemotherapy regimens in recurrent/refractory ES: cyclophosphamide & topotecan, irinotecan & temozolomide, gemcitabine & docetaxel, and high dose ifosfamide, in order to identify the best one for use as a backbone in future treatment with respect to efficacy (imaging response and survival), toxicity and acceptability to patients.;Secondary Objective: N/A;Primary end point(s): Phase II: Objective response as measured by RECIST criteria<br>Phase III: Event-free survival;Timepoint(s) of evaluation of this end point: the main assessment time point for the phase II study will be at baseline and after 4 cycles of chemotherapy<br><br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Progression-free survival (PFS)<br>Overall survival (OS)<br>Quality of Life (QoL)<br>Adverse events and toxicity, defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0<br>Days spent in hospital<br>Imaging response<br>;Timepoint(s) of evaluation of this end point: PFS and OS will be assessed at every clinic visit<br>QoL will be assessed at baseline and after 2 and 4 cycles of chemotherapy<br>Adverse events, toxicity and 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)<br>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.<br>imaging: cycle 2, cycle 6 + End of trial