2024-512827-36-00招募中2 期
MEGACEP_Prospective Phase II Study Evaluating a Multimodal Care of Inguinal Node Metastasis in Squamous Cell Carcinoma of the Penis by Bilateral Lymphadenectomy and Chemotherapy TIP
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Unicancer
- 入组人数
- 37
- 试验地点
- 18
- 主要终点
- Survival without locoregional lymph node recurrence [ Time Frame: 24 months ] checked by inguinal ultrasound
研究概览
简要总结
Evaluation of the rate of survival without locoregional lymph node recurrence (inguinal and iliac) in patients with pN+ squamous cell carcinoma of the penis presenting with inguinal lymph node metastases after treatment combining adjuvant or neoadjuvant TIP chemotherapy with inguinal lymph node dissection
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy
- •Normal calcemia and kaliemia
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN
- •Creatinine clearance ≥60 mL/min (MDRD method),
- •Left ventricular ejection fraction (LVEF) >50%
- •Patients having received, read the information note and signed consent
- •Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
- •Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
- •Patients undergoing a social security scheme
- •Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Patients with capsular involvement if inguinal lymph nodes are affected exclusively Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2
- •Metastatic lymph node involvement
- •Patients M0 or Mx
- •Age ≥18 ans
- •Eastern Cooperative Oncology Group (ECOG) 0-1
- •Leucocytes ≥1.5 g/L
- •Hemoglobin ≥9 g/dL
- •Platelets ≥100 000/mm³
排除标准
- •Fixed inguinal lymph nodes
- •Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial
- •Patients deprived of their liberty or under court protection including guardianship
- •Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator
- •Immunocompromised patients including with known seropositivity (HIV),
- •Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients
- •Iliac lymph nodes
- •Prior chemotherapy for squamous cell carcinoma of the penis
- •Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
- •Patients treated with phenytoin
- •Patients with hearing loss >Grade 1 (CTCAE V4.03),
- •Patients with cardiopulmonary disease-indicating against overhydration
- •History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell
- •Patient received a live attenuated vaccine within 30 days prior to inclusion
结局指标
主要结局
Survival without locoregional lymph node recurrence [ Time Frame: 24 months ] checked by inguinal ultrasound
Survival without locoregional lymph node recurrence [ Time Frame: 24 months ] checked by inguinal ultrasound
次要结局
未报告次要终点
研究者
Nourredine AIT RAHMOUNE
Scientific
Unicancer
研究点 (18)
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