EUCTR2016-000981-46-FR进行中（未招募）1 期
First-line treatment of Ewing tumours with primary extrapulmonary dissemination in patients from 2 to 50 years
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1 - Ewing tumour histologically or cytologically confirmed, harboring a specific transcript, and with extrapulmonary metastases.
- •2 - Ewing tumour not previously treated.
- •3 - Age between 2 and 50 years.
- •4 - Measurable disease by cross sectional imaging (RECIST 1.1) or evaluable disease with functional metabolic PET scan or other methods (e.g., cytology/histology).
- •5 - General status compatible with the study treatments (Lansky = 50%, or Karnofsky = 50%, or ECOG = 2).
- •6 - No absolute contra-indication of Busulfan-Melphalan if radiotherapy of the primary tumour is necessary.
- •7 - Adequate cardiac and renal functions:
- •oCreatinine < 1.5 of normal for age or clearance > 60 ml/min/1.73 m²;
- •oLeft Ventricular Ejection Fraction (LVEF) > 50% and/or shortening fraction > 28%.
- •8 - No underlying disease contra-indicating the study treatments.
- •9 - Patient likely compliant with the recommended study medical monitoring during and after treatments.
- •10 - Patients of childbearing potential must agree to use adequate contraception for the duration of study treatments and up to 6 months following completion of therapy.
- •11 - Females of childbearing potential must have a negative serum ß-HCG pregnancy test within 10 days prior study inclusion, and/or urine pregnancy test within 48 hours before the first administration of the study treatment.
- •12 - Patients covered by a health insurance system.
- •13 - Patient, or patient’s legal representative, informed and having signed the informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1 - Age below 2 or greater than 50 years.
- •2 - Ewing tumour localized, or solely with pleural and/or lung metastases.
- •3 - Primary tumour localized to the spine.
- •4 - Concomitant disease, particularly infectious disease, likely to interfere with patient’s treatment.
- •5 - History of cancer, according to investigator’s judgment.
- •6 - Life expectancy < 2 months.
- •7 - Patient already included in another clinical trial with an investigational drug.
- •8 - Pregnant or breastfeeding patient.
- •9 - Person deprived of liberty or under guardianship.
- •10 - Patient likely unable to comply with the study medical monitoring for geographical, social or psychological reasons.
研究者
相似试验
已完成
3 期
The role of surgery of the primary tumour with few or -absent symptoms in patients with synchronous unresectable metastases of colorectal cancer, a randomized phase III studybowel cancerrectum cancer10017990colorectal cancerNL-OMON50614Dutch Colorectal Cancer Group176
进行中（未招募）
不适用
Tratamiento de primera línea del linfoma difuso de célula grande B (LDCGB) con quimioterapia a dosis densas e inmunoterapia (R-CHOP/14) en pacientes mayores de 65 años, y en menores de 65 años de riesgo bajoFirst-line treatment of diffuse large B-cell lymphoma (DLBCL) with dose-dense chemotherpahy and immunotherapy (R-CHOP/14) in patients older than 65 years and in low-risk patients younger than 65 years - R-CHOP/14infoma difuso de célula grande B (LDCGB)Diffuse large B-cell lymphoma (DLBCL)EUCTR2005-005110-20-ESGEL/TAMO (Grupo Cooperativo Español de Linfoma/Transplante Antólogo de Médula Ósea)
进行中（未招募）
不适用
Traitement de première ligne des lymphomes du manteau de patients agés de 65 à 80 ans. Evaluation de l'efficacité, de la toxicité et de facteurs pronostiques moléculaires de l'inhibiteur du protéasome ( PS341-Velcade) associé à une chimiothérapie et une immunothérapie par rituximab ( schéma RiPAD + C) - MANTEAU 2006 SAEUCTR2006-004768-30-FRGOELAMS
进行中（未招募）
1 期
Sequential first-line therapy in metastatic colorectal cancer with Capecitabine/FUFA, Irinotecan and Bevacizumabmetastatic colorectal cancerMedDRA version: 20.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864EUCTR2009-013099-38-DEKlinikum der Universität München, Anstalt des öffentlichen Rechts vertreten durch den Vorstand450
进行中（未招募）
不适用
Dosisdichte 1st-line Therapie des metastasierten Mammakarzinoms mit Paclitaxel und liposomalem Doxorubicin (Myocet®)metastasiertes MammakarzinomMedDRA version: 9.1Level: LLTClassification code 10006187Term: Breast cancerEUCTR2005-004234-41-DEOtto-von-Guericke Universität Magdeburg