EUCTR2021-000571-37-FR招募中1 期
A multicenter, randomized, open-label phase II trial evaluating the association of Gadolinium-based nanoparticles (AGuIX®) with radiotherapy for the therapeutic management of patients with progressive / recurrent inoperable musculoskeletal tumor lesion. - NANO-RT-MSK
Centre Léon Bérard0 个研究点目标入组 132 人开始时间: 2021年6月3日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 132
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
- •I1. Male or female patients aged of at least 18 years on day of signing informed consent.
- •I2. Histologically-confirmed diagnosis of:
- •- Metastatic renal cancer, sarcoma, or melanoma, with the presence of at least one progressive / recurrent inoperable musculoskeletal tumor lesion eligible for radiotherapy
- •Note: - Only one lesion can be treated with this protocol.
- •- Long bones should be excluded this is not a good indication for stereotactic radiotherapy.
- •- or Non-metastatic sarcoma with musculoskeletal tumor lesion eligible for radiotherapy i.e.:
- •o inoperable
- •o partially resected with macroscopic (R2) residual tumor
- •o locally recurrent lesion after surgery (R0 or R1).
- •I3. For metastatic patients:
- •o Currently being treated with first- or second-line therapy in the metastatic setting.
- •o No RECIST v1.1 progression of tumor lesions that will not be treated by RT, documented by radiological assessment within 4 weeks before inclusion.
- •o Radiological evidence of a maximum of 5 metastases in less than 3 organs.
- •I4. Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
- •I5. Life expectancy of at least 12 months.
- •I6. For vertebral metastatic lesions, Spinal Instability Neoplastic Score (SINS) < 12 and BILSKY grade < 2.
- •Note: In case of BILSKY grade 2, a surgical opinion must be taken before inclusion. In case of SINS = 12 and BILSKY grade 3, decompression or stabilization surgery must be performed before inclusion (refer to criterion E5).
- •I7. Documented adequate organ function as defined in the table below according to laboratory tests performed within 7 days prior Day 1:
- •Absolute neutrophil count (ANC) = 1.0 G/L ; Platelets = 75 G/L ; Hemoglobin = 8 g/dL (without transfusion within 7 days) ; Serum creatinine OR Creatinine clearance according to CKD-EPI = 1.5 x Upper Limit of Normal (ULN) OR = 50 mL/min/1.73m2 ; AST and ALT = 3 x ULN (or = 5.0 ULN in case of liver metastasis or hepatic infiltration) ; INR and Activated Partial Thromboplastin Time (aPTT)=1.5 x ULN
- •I8. Women of child-bearing potential must have a negative serum pregnancy test at Screening and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 3 months after the last dose of the study drug.
- •I9. Fertile men must agree to use contraceptive measures up to 3 months after the last dose of study drug.
- •I10. Patients who understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures. Patient should be able and willing to comply with study visits and procedures as per protocol.
- •I11. Patients must be covered by a medical insurance.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 62
排除标准
- •E1. Patients participating to another clinical trial with an investigational agent.
- •E2. Patients who have not recovered from significant adverse events (i.e. grade > 2 AE according to NCI CTCAE v5.0) due to prior treatment with anti-cancer agents with the exception of any grade alopecia or lab values presented in inclusion criteria I8.
- •E3. Patients with carcinomatous meningitis, peritoneal carcinosis or bone marrow involvement.
- •E4. Patients with prior local treatment with radiotherapy of the tumor lesion eligible for this protocol.
- •E5. Patients currently treated with Bevacizumab.
- •E6. Patients using, or requirement to use while on the study, or not respecting the minimal wash-out period of concomitant medications.
- •E7. Patients with known arterio-venous malformation near the treatment area.
- •E8. Patients unable to undergo or tolerate Magnetic Resonance Imaging or with known contra-indication (e.g. cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements or certain metal implants).
- •E9. Patients with known contra-indication, sensitivity or allergy to gadolinium.
- •E10. Any clinically significant and/or uncontrolled medical disease that could compromise the patient's ability to tolerate study drug or would likely interfere with study procedures or results.
- •E11. Patients who are pregnant or breastfeeding women or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 3 months after the last dose of trial treatment.
研究者
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