2024-516078-31-00招募中3 期
rEECur: International Randomised Controlled Trial of Chemotherapy for the Treatment of Recurrent and Primary Refractory Ewing Sarcoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 436
- 试验地点
- 54
- 主要终点
- Event-free survival time (EFS)
研究概览
简要总结
The objectives of the study are to compare systemic anti-cancer therapy regimens in recurrent/refractory ES in order to identify the best one with respect to efficacy (imaging response and survival), toxicity and acceptability to patients.
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Histologically confirmed Ewing or Ewing-like sarcoma of the bone or soft tissues. Histological confirmation either at initial diagnosis or disease progression.
- •Patient agrees to use effective contraception during therapy and for 12 months after last trial treatment, where applicable.
- •For IFOS/IFOS-L randomisation only: Adequate liver function: bilirubin <3 x ULN and ALT or AST < 5 x ULN.
- •For IFOS/IFOS-L randomisation only: Left ventricular ejection fraction ≥50% at baseline as determined by echocardiography.
- •For IFOS/IFOS-L randomisation only: Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as: a. BP <95th percentile for sex, age, and height. Subjects >18 years of age should have BP ≤150/90 mm Hg at screening.
- •For IFOS/IFOS-L randomisation only: Urine dipstick <2+ for proteinuria. If ≥2+ proteinuria on dipstick, a spot urine protein:creatinine ratio test must be < CTCAE grade 2 Proteinuria.
- •Written informed consent from the patient and/or parent/legal guardian.
- •Radiological evidence of disease progression during or after completion of first or any subsequent line of treatment.
- •Age ≥ 2 years (* Trial sites in Austria will only recruit patients aged ≥2 years<30 years due to the conditional approval issued by their ethics committee).
- •Eligible for randomisation between at least two open study arms.
- •Adequate renal function defined as GFR ≥60 ml/min/1.73m
- •If GFR is calculated and is <90 ml/min/1.73m2, an isotopic GFR should be performed to confirm adequate renal function.
- •Patient assessed as medically fit to receive trial treatment.
- •Date of planned randomisation within 4 weeks of baseline imaging.
- •Documented negative pregnancy test for female patients of childbearing potential.
排除标准
- •Absolute Neutrophil Count (ANC) <1.0 x 109/L or platelets <75 x 109/L.
- •Pre-existing medical condition that would necessitate a dose modification during cycle 1 as described in section 7 of the protocol.
- •Any central neurotoxicity with previous ifosfamide treatment.
- •For CE randomisation only: Carboplatin is contraindicated in patients with actively bleeding tumours. Therefore, patients with actively bleeding tumours are not eligible for the CE randomisation.
- •For IFOS/IFOS-L randomisation only: Clinically significant ECG abnormality, including a marked baseline prolonged QT or QTc interval (eg, a repeated demonstration of a QTc interval >480 msec).
- •For IFOS/IFOS-L randomisation only: History of aneurysm.
- •For IFOS/IFOS-L randomisation only: Arterial Thromboembolism in previous 6 months.
- •For IFOS/IFOS-L randomisation only: Gastrointestinal or non-gastrointestinal fistula.
- •For IFOS/IFOS-L randomisation only: Gastrointestinal bleeding or active haemoptysis within previous 3 weeks.
- •For IFOS/IFOS-L randomisation only: Major surgery within previous 3 weeks.
- •For IFOS/IFOS-L randomisation only: Previous treatment with tyrosine kinase inhibitors.
- •Clinical evidence of nephrotic syndrome.
- •For IFOS/IFOS-L randomisation only: Radiographic evidence of intratumoral cavitation, encasement, or invasion of a major blood vessel, or proximity to major blood vessels with potential risk of severe haemorrhage associated with tumor shrinkage/necrosis after lenvatinib therapy.
- •Follow-up not possible due to social, geographic or psychological reasons.
- •Previous randomisation into the rEECur trial.
- •Patients with a contraindication or hypersensitivity to any IMP may not be randomised to receive an arm that contains the contraindicated IMP.
- •Patients who have previously received one of the trial regimens off-trial may not be randomised to receive that regimen again. Patients who have had ifosfamide during first line therapy may receive the IFOS or IFOS-L arm. There is no requirement for a minimum time between receiving first line ifosfamide and entry to rEECur.
- •Cytotoxic chemotherapy or other investigational medicinal product (IMP) within previous two weeks.
- •Radiotherapy to target lesion within previous six weeks.
- •Pregnant or breastfeeding women.
结局指标
主要结局
Event-free survival time (EFS)
Event-free survival time (EFS)
次要结局
- Objective imaging response (OR) according to RECIST 1.1 criteria after 2, 4, and 6 cycles for CE and after 2 and 4 cycles for IFOS and IFOS-L, and at the end of trial treatment for all arms
- Progression-free survival time (PFS)
- Overall survival time (OS)
- Toxicity, defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.0 (see Appendix 2 of protocol)
- PET-CT response after 4 cycles
- Quality of life (QoL)
- Days spent in hospital
研究者
Clinical Trial Coordinator
Scientific
The University Of Birmingham
研究点 (54)
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