Yükleniyor... / Loading...
First-line Treatment of Ewing Tumours With Primary Extrapulmonary Dissemination in Patients From 2 to 50 Years (CombinaiR3)
Bu çalışma, akciğer dışına yayılmış (metastatik) Ewing tümörü (Ewing tumours) bulunan hastalarda birinci basamak kemoterapi ve tedavi rejimlerini (VDC-IE, TEMIRI, Busulfan-Melphalan konsolidasyonu, cerrahi ve radyoterapi gibi) değerlendirmiştir. Çalışmaya, daha önce tedavi almamış, 2 ile 50 yaş arasındaki hastalar katılmıştır. Çalışma Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: 1. \- Ewing tumour histologically or cytologically confirmed, harboring a specific transcript, and with extrapulmonary metastases (including nodal extension) - histology and FISH results must be consistent, specific transcript can be obtained after inclusions. 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, positron emission tomography scanner (PET SCAN) or other methods (e.g., cytology/histology). 5. \- General status compatible with the study treatments (LANSKY score ≥ 50%, or Karnofsky ≥ 50%, or Eastern Cooperative Oncology Group (ECOG) ≤ 2). 6. \- Adequate bone marrow function (not applicable in case of bone marrow disease). * Platelets ≥ 100 x 109 /L * Absolute Neutrophil Count (ANC) ≥ 1 x 109 /L * Hemoglobin ≥ 8g /dL. 7. \- Adequate liver function : * Aspartate Aminotransferase (AST) and Alanine Transferase (ALT) ≤ 5 x Upper Limit Normal (ULN) * Total Bilirubin ≤ 2 Upper Limit Normal (ULN). If total bilirubin \> 2xULN, Bilirubin Conjugated Fraction (BCF) ≤ 2 x ULN 8. \- No absolute contra-indication of Busulfan-Melphalan if radiotherapy of the primary tumour is necessary with specific attention to patient with primary spinal tumor. 9. \- Adequate cardiac and renal functions: * Creatinine \< 1.5 of normal for age or clearance \> 60 ml/min/1.73 m²; * Left Ventricular Ejection Fraction (LVEF) \> 50% and/or shortening fraction \> 28%. 10. \- No underlying disease contra-indicating the study treatments. 11. \- Patient likely compliant with the recommended study medical monitoring during and after treatments. 12. \- Patients of childbearing potential must agree to use adequate contraception for the duration of study treatments and up to 12 months for women and 6 months for men following completion of therapy. 13. \- Females of childbearing potential must have a negative serum β-human chorionic gonadotropin (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. 14. \- Patients covered by a health insurance system. 15. \- Patient, or patient's legal representative, informed and having signed the informed consent. Exclusion Criteria: 1. \- Age below 2 or greater than 50 years. 2. \- Ewing tumour localized, or solely with pleural and/or lung metastases. 3. \- Concomitant disease, particularly infectious disease, likely to interfere with patient's treatment. 4. \- History of cancer, according to investigator's judgment. 5. \- Life expectancy \< 2 months. 6. \- Patient already included in another clinical trial with an investigational drug. 7. \- Pregnant or breastfeeding patient. 8. \- Person deprived of liberty or under guardianship. 9. \- Patient likely unable to comply with the study medical monitoring for geographical, social or psychological reasons.