EUCTR2018-000515-24-SE进行中（未招募）1 期
FaR-RMS: An overarching study for children and adults with Frontline and Relapsed RhabdoMyoSarcoma - FaR-RMS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,672
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
- •1. Histologically confirmed diagnosis of RMS (except pleomorphic RMS)
- •2. Written informed consent from the patient and/or the parent/legal guardian
- •Inclusion criteria for all randomisations and registrations:
- •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
- •Written informed consent from the patient and/or the parent/legal guardian
- •Medically fit to receive treatment
- •Frontline chemotherapy specific inclusion:
- •Entered in to the FaR-RMS study at diagnosis
- •No prior treatment for RMS other than surgery
- •Documented negative pregnancy test for female patients of childbearing potential
- •Adequate hepatic function: Total bilirubin = 1.5 times upper limit of normal (ULN) for age, unless the patient is known to have Gilbert’s syndrome
- •CT1a specific inclusion
- •VHR disease
- •Age = 6 months
- •Available for randomisation =60 days after diagnostic biopsy/surgery
- •Fractional Shortening = 28%
- •Absolute neutrophil count =1.0x 10^9/L (except in patients with documented bone marrow disease)
- •Platelets = 80 x 10^9/L (except in patients with documented bone marrow disease)
- •CT1b specific inclusion
- •HR disease
- •Age = 6 months
- •Available for randomisation =60 days after diagnostic biopsy/surgery
- •Absolute neutrophil count =1.0x 10^9/L
- •Platelets = 80 x 10^9/L
- •Radiotherapy Inclusion
- •Entered in to the FaR-RMS study (at diagnosis or prior to radiotherapy randomisation)
- •VHR, HR and SR disease
- •= 2 years of age
- •Receiving frontline induction treatment as part of the FaR-RMS trial or with a IVA/IVADo based chemotherapy regimen. Note that, patients for whom ifosfamide has been replaced with cyclophosphamide will be eligible
- •Documented negative pregnancy test for female patients of childbearing potential
- •RT1a Specific Inclusion
- •Primary tumour deemed resectable (predicted R0/ R1 resection feasible) after 3 cycles of induction chemotherapy (6 cycles for metastatic disease)
- •Adjuvant radiotherapy required in addition to delayed surgical resection of the primary tumor (local decision).
- •Available for randomisation after cycle 3 and prior to the start of cycle 5 of induction chemotherapy for localised disease, or after cycle 6 and prior to the start of cycle 8 for metastatic disease
- •RT1b Specific Inclusion
- •Primary tumour deemed resectable (predicted R0/ R1 resection feasible) after 3 cycles of induction chemotherapy (6 cycles for metastatic disease)
- •Adjuvant radiotherapy required in addition to surgical resection (local decision).
- •Available for randomisation after cycle 3 and prior to the start of cycle 6 of induction chemotherapy for localised disease, or after cycle 6 and prior to the start of cycle 9 for metastatic disease
- •Higher Local Failure Risk (HLFR) based on presence of either of the following criteria:
- •Unfavourable site
- •Age = 18yrs
- •RT1c Specific Inclusion
- •Primary radiotherapy indicated (local decision)
- •Available for randomisation after cycle 3 and prior to the start of cycle 6 of induction chemotherapy for localised disease, or after cycle 6 and prior to the start of cycle 9 for metastatic disease
- •Higher Local Failure Risk (HLFR) based on presence of either of the following criteria:
- •Unfavourable site
- •Age = 18yrs
- •RT2 Specific Inclusion
- •Available for randomisation after cycle 6 and before the start of cycle 9 of induction chemo
排除标准
- •CT1a and CT1b specific exclusion
- •Active > grade 2 diarrhoea
- •Prior allo- or autologous Stem Cell Transplant
- •Uncontrolled inter-current illness or active infection
- •Pre-existing medical condition precluding treatment
- •Known hypersensitivity to any of the treatments or excipients
- •Second malignancy
- •Pregnant or breastfeeding women
- •Urinary outflow obstruction that cannot be relieved prior to starting treatment
- •Active inflammation of the urinary bladder (cystitis)
- •Radiotherapy specific exclusion
- •Prior allo- or autologous Stem Cell Transplant
- •Second malignancy
- •Pregnant or breastfeeding women
- •Receiving radiotherapy as brachytherapy
- •CT2a and CT2b specific Exclusion
- •Prior allo- or autologous Stem Cell Transplant
- •Uncontrolled inter current illness or active infection
- •Second malignancy
- •Pregnant or breastfeeding women
- •Urinary outflow obstruction that cannot be relieved prior to starting treatment
- •Active inflammation of the urinary bladder (cystitis)
- •CT3 specific exclusion
- •Progression during frontline therapy without previous response (=Refractory to first line treatment)
- •Prior regorafenib or temozolomide
- •Active > grade 1 diarrhoea
- •ALT or AST >3.0 x upper limit normal (ULN)
- •Bilirubin, Total >1.5 x ULN; total bilirubin is allowed up to 3 x ULN if Gilbert’s syndrome is documented
- •Patients with unstable angina or new onset angina (within 3 months of planned date of randomisation), recent myocardial infarction (within 6 months of randomisation) and those with cardiac failure New York Heart Association (NYHA) Classification 2 or higher
- •Cardiac abnormalities such as congestive heart failure (Modified Ross Heart Failure Classification for Children = class 2) and cardiac arrhythmias requiring antiarrhythmic therapy (beta blockers or digoxin are permitted)
- •Uncontrolled hypertension > 95th centile for age and gender
- •Prior allo- or autologous Stem Cell Transplant
- •Uncontrolled inter-current illness or active infection
- •Pre-existing medical condition precluding treatment
- •Known hypersensitivity to any of the treatments or excipients
- •Second malignancy
- •Pregnant or breastfeeding women
- •Exclusion criterias for Phase 1b are omittes as we do not intend to participate in this part of the study.
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