2024-511989-36-00招募中3 期
INTER-EWING-1: International Clinical Research Programme to Improve Outcomes in Newly Diagnosed Ewing Sarcoma – Trial 1
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 498
- 试验地点
- 58
- 主要终点
- The primary end point for all randomisations is Event-free survival, defined as the time from randomisation until first failure event
研究概览
简要总结
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)
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 65+ Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Study Entry:
- •Any histologically and genetically confirmed Ewing sarcoma of bone or soft tissue, or round cell sarcomas which are ‘Ewing’s-like’ but negative for EWSR1-Fli gene rearrangement
- •Randomisation B1 & B2:
- •Patient agrees to use contraception during therapy and for 12 months after last trial treatment (females) or 6 months after last trial treatment (males), where patient is sexually active
- •Randomisation B1 & B2:
- •Written informed consent from the patient and/or the parent/legal guardian
- •Randomisation A: To be further defined on completion of the externally sponsored phase 1b study. substantial modification will be submitted to the relevant competent authority and ethics committee(s) to include these details prior to the opening of Randomisation A.
- •Randomisation C:
- •Entered into the INTER-EWING-1 study
- •Randomisation C:
- •Received induction/ consolidation chemotherapy with a VDC/IE/VC/VAI/BuMel based regimen
- •Randomisation C:
- •Have responded to induction treatment and not progressed
- •Randomisation C:
- •Medically fit to receive treatment
- •Randomisation C:
- •Absence of severe vincristine neuropathy – i.e. requiring discontinuation of vincristine treatment
- •Randomisation C:
- •Adequate liver function: bilirubin <3 x ULN and ALT or AST < 5 x ULN
- •Randomisation C:
- •Documented negative pregnancy test for female patients of childbearing potential
- •Randomisation B1:
- •Patients requiring definitive radical radiotherapy to primary tumour site as sole local therapy following discussion by local multidisciplinary team (see INTER-EWING-1 QUARTET RTQA guidelines on factors to be considered for definitive radiotherapy). This includes patients who have undergone an R2 resection of the primary tumour (macroscopic residual tumour), requiring definitive radical radiotherapy
- •Randomisation C:
- •Patient agrees to use contraception during therapy and for 12 months after last trial treatment (females) or 6 months after last trial treatment (males), where patient is sexually active (see section 5)
- •Randomisation C:
- •Written informed consent from the patient and/or the parent/legal guardian
- •Randomisation B2:
- •Patients requiring post-operative radiotherapy following discussion by local multidisciplinary team at the multidisciplinary team meeting
- •Study Entry:
- •Age ≥ 2 years
- •Study entry:
- •Written informed consent from the patient and/or the parent/legal guardian
- •Randomisation B1 & B2:
- •Entered into the INTER-EWING-1 study
- •Randomisation B1 & B2:
- •Received induction/consolidation chemotherapy with a VDC/IE/VC/VAI/BuMel based regimen
- •Randomisation B1 & B2:
- •Patient assessed as medically fit to receive the radiotherapy
- •Randomisation B1 & B2:
- •Documented negative pregnancy test for female patients of childbearing potential
排除标准
- •Study entry:
- •Previous malignancy
- •Randomisation C:
- •Urinary outflow obstruction that cannot be relieved prior to starting treatment
- •Randomisation C:
- •Uncontrolled significant inter-current illness or active infection
- •Randomisation C:
- •Active inflammation of the urinary bladder (cystitis)
- •Randomisation C:
- •Known contraindication or hypersensitivity to any of the treatments or excipients
- •Randomisation C:
- •Pregnant or breastfeeding women
- •Randomisation B1 & B2:
- •Previous radiotherapy to the same site
- •Randomisation B1 & B2:
- •Pregnant or breastfeeding women
- •Randomisation B1 & B2:
- •BuMel high dose chemotherapy within previous 10 weeks
- •Randomisation B1:
- •Patients who have had a R1 or R0 surgical resection of their tumour
- •Randomisation B1:
- •Previous high dose chemotherapy including busulfan when specified dose constraints to critical organs cannot be met
- •Randomisation B2:
- •R2 resection (macroscopic residual tumour)
- •Randomisation B2:
- •Patients treated by surgery with wide resection (R0 and all tissues involved by the prechemotherapy tumour volume have been completely resected) and have good histological response (< 10% viable cells), small tumour volume (< 200 mls at diagnosis), of the limb.
- •Randomisation A: To be further defined on completion of the externally sponsored phase 1b study. substantial modification will be submitted to the relevant competent authority and ethics committee(s) to include these details prior to the opening of Randomisation A.
结局指标
主要结局
The primary end point for all randomisations is Event-free survival, defined as the time from randomisation until first failure event
The primary end point for all randomisations is Event-free survival, defined as the time from randomisation until first failure event
次要结局
- Randomisation A: Induction chemotherapy Overall Survival, Toxicity, Cancer Quality of Life Measures, Histological response (if surgery is performed)
- Randomisations B1 & B2: Radiotherapy Local Failure-Free Survival Time, Overall Survival, Toxicity, Achievement of local control, Acute post-radiotherapy toxicity, Late toxicity, Cancer Quality of Life Measures
- Randomisation C: Maintenance therapy Overall Survival, Toxicity, Cancer Quality of Life Measures
研究者
Clinical Trial Coordinator
Scientific
The University Of Birmingham
研究点 (58)
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