International Clinical Research Programme to Improve Outcomes in Newly Diagnosed Ewing Sarcoma – Trial 1 (INTER-EWING-1)

Research summary

The primary objectives for this trial are related to each of the trial questions. For the chemotherapy questions,the objectives are to determine: • whether outcome in newly diagnosed metastatic ES patients can be improved with the addition of regorafenib to the standard backbone chemotherapy VDC/IE when compared with VDC/IE alone (Randomisation A) •whether the addition of 6 cycles of maintenance chemotherapy of vinorelbine and cyclophosphamide improves the outcome for patients. (Randomisation C) For the radiotherapy questions,the objectives are to determine: • whether dose escalation of radiotherapy improves the outcome in patients with inoperable disease (Randomisation B1) •which of the two post-operative radiotherapy doses following surgical resection of the primary tumour site will result in achieving optimal outcome (Randomisation B2) primary outcome measure for all trial questions is Event-free survival defined as the time from randomisation until first failure event. the study also has the following secondary objectives. For each randomisation: A: Induction chemotherapy OS,Toxicity,QoL,Histological response (if surgery is performed) B1 & B2: Radiotherapy LFFS,OS,Toxicity,Achievement of local control,Acute post-radiotherapy toxicity,Late toxicity,QoL C: Maintenance therapy OS,Toxicity,QoL Key OS – Overall survival time QoL – Cancer quality of life measures LFFS – Local failure-free survival time Adverse events and toxicity will be categorised and graded using CTCAE v5.0. Histological response is the percentage of viable tumour cells observed post-induction chemotherapy surgery of the primary tumour. Achievement of local control is radiologically confirmed at the end of treatment. Acute post radiotherapy toxicity is defined as a radiotherapy related adverse event grade 3 and above during and up to 120 days after completing radiotherapy Late toxicity is radiotherapy related adverse event grade 3 and above occurring from 120 days after completing radiotherapy.

Principal Investigator

Dr Shaun Robert Wilson

Contact us

Email: rhiannon.collins@ouh.nhs.uk

IRAS number

1005108