2024-516078-31-00
招募中
2/3 期
rEECur: International Randomised Controlled Trial of Chemotherapy for the Treatment of Recurrent and Primary Refractory Ewing Sarcoma
概览
- 阶段
- 2/3 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)
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.
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.
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)
Loading locations...
相似试验
进行中（未招募）
2 期
Clinical trial to compare efficacy and safety of standard chemotherapy versus letrozole plus abemaciclib, chosen randomly, as neoadjuvant therapy (deliver before breast cancer surgery), with positive Hormone Receptors (female hormones) and negative HER2 (protein involved in cell division that is located in the surface of many cells), intermediate/high risk breast cancer.2024-514395-40-00Fundacion Grupo Espanol De Investigacion En Cancer De Mama200
进行中（未招募）
3 期
Pembrolizumab as adjuvant therapy for resectable high-risk LA cSCC2022-500395-57-00Merck Sharp & Dohme Corp.267
招募中
不适用
Complete Remission After Treatment With Biologics for Nasal PolypsNCT07268313Rigshospitalet, Denmark66
进行中（未招募）
2 期
Study of chemotherapy and immunotherapy for patients with lung cancer bounded in the thorax and potentially resectable2024-513731-24-00Fundacion GECP90
招募中
3 期
A study of tucatinib with trastuzumab and mFOLFOX6 versus standard of care treatment in first-line HER2+ metastatic colorectal cancer2024-514180-25-00Seagen Inc.155