ISRCTN17938906进行中（未招募）3 期
International clinical research programme to improve outcomes in newly diagnosed Ewing sarcoma – Trial 1 (INTER-EWING-1)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria for study entry – Mandatory first point of study entry, for all patients
- •1. 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
- •2. Age > 2 years
- •3. Written informed consent from the patient and/or the parent/legal guardian
- •inclusion criteria for randomisation A will be defined on completion of the externally sponsored phase 1b study. A substantial amendment will be submitted to the relevant competent authority and ethics committee(s) to include these details prior to the opening of Randomisation A.
- •Radiotherapy Randomisations – B1 and B2
- •Inclusion Criteria
- •1. Entered into the INTER-EWING-1 study
- •2. Received induction/consolidation chemotherapy with a VDC/IE/VC based regimen
- •3. Patient assessed as medically fit to receive the radiotherapy
- •4. Documented negative pregnancy test for female patients of childbearing potential
- •5. 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
- •6. Written informed consent from the patient and/or the parent/legal guardian
- •Randomisation B1 specific Inclusion criteria– Definitive radical radiotherapy dose finding randomisation
- •1. Patients requiring definitive radical radiotherapy to primary tumour site as sole local therapy following discussion by local multidisciplinary team.
- •2. Patients who have undergone an R2 resection of the primary tumour (macroscopic residual tumour), requiring definitive radical radiotherapy
- •Randomisation B2 specific Inclusion criteria– Post-operative radiotherapy dose finding randomisation
- •1. Patients requiring post-operative radiotherapy following discussion by local multidisciplinary team
- •according to multidisciplinary team meeting.
- •Randomisation C – Maintenance chemotherapy randomisation
- •Inclusion Criteria
- •1. Entered into the INTER-EWING-1 study
- •2. Received induction/ consolidation chemotherapy with a VDC/IE/VC based regimen
- •3. Have responded to induction treatment and not progressed
- •4. Medically fit to receive treatment
- •5. Absence of severe vincristine neuropathy – i.e. requiring discontinuation of vincristine treatment
- •6. Adequate liver function: bilirubin <3 x ULN and ALT or AST < 5 x ULN
- •7. Documented negative pregnancy test for female patients of childbearing potential
- •8. 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
- •9. Written informed consent from the patient and/or the parent/legal guardian
排除标准
- •Exclusion Criteria for study entry
- •1. Previous malignancy
- •Exclusion criteria for randomisation A will be defined on completion of the externally sponsored phase 1b study. A substantial amendment will be submitted to the relevant competent authority and ethics committee(s) to include these details prior to the opening of Randomisation A.
- •Exclusion Criteria Radiotherapy Randomisations – B1 and B2
- •1. Previous radiotherapy to the same site
- •2. Pregnant or breastfeeding women
- •3. BuMel high dose chemotherapy within previous 10 weeks
- •Randomisation B1 specific Exclusion criteria– Definitive radical radiotherapy dose finding randomisation
- •1. Patients who have had a R1 or R0 surgical resection of their tumour
- •2. Previous high dose chemotherapy including busulfan when specified dose constraints to critical organs cannot be met (please see INTER-EWING-1 Quartet RTQA guidelines for more details)
- •Randomisation B2 specific Exclusion criteria– Post-operative radiotherapy dose finding randomisation
- •1. R2 resection (macroscopic residual tumour)
- •2. Patients treated by surgery with wide resection (R0 and all tissues involved by the prechemotherapy
- •tumour volume have been completely resected), good histological response (< 10% viable cells), small tumour volume (< 200 mls at diagnosis), of the limb.
- •Randomisation C – Maintenance chemotherapy randomisation
- •Exclusion Criteria
- •1. Urinary outflow obstruction that cannot be relieved prior to starting treatment
- •2. Uncontrolled significant inter-current illness or active infection
- •3. Active inflammation of the urinary bladder (cystitis)
- •4. Known contraindication or hypersensitivity to any of the treatments or excipients
- •5. Pregnant or breastfeeding women
研究者
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