Registrationsdatum der Studie
Einschluss der ersten teilnehmenden Person
Globales Abschlussdatum der Studie
rEECur: an international randomised controlled trial of chemotherapy for the treatment of recurrent and primary refractory Ewing sarcoma
Design der Studie
Multi-Arm, Multi-Stage (MAMS), randomised phase II/III, open-label multicentre international trial (Treatment)
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.
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.
Kontakt für Auskünfte
Seventh Framework Programme