EUCTR2019-000364-24-IT进行中（未招募）1 期
Randomized open label multicentric phase II trial of Adjuvant RadioChemotherapy, Concurrent versus Sequential, in resected non-small cell lung cancer (NSCLC) patients with mediastinal involvement (pN2). The ARCCS trial. - ARCCS
AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA0 个研究点目标入组 100 人开始时间: 2021年5月24日最近更新:
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
- 100
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
- •Patients between the ages of 18 and 75.
- •Patients with NSCLC with a stologically proven diagnosis.
- •Clinically non-metastatic patients at a distance (CT or MRI negative for metastases
- •cerebral, chest CT complete abdomen or PET-CT with 18 fluorine-desoxy-glucose negative for
- •distant metastasis) before enrollment
- •Patients undergoing lobectomy or sublobar resection and ilo-medistinic lymphadenectomy.
- •Patients treated surgically with macroscopically radical resection (R0-R1) with mediastinal lymph node involvement (pN2), any stage of T.
- •ECOG Performance Status 0-1
- •No other surgical, chemotherapy or radiotherapy treatments for neoplasia, except of non-melanoma tumors of the skin or in situ tumor of the cervix and other solid tumors
- •which radical treatment was completed at least three years before it was entered into
- •study and for which the patient has remained continuously free of disease.
- •Signature of informed consent.
- •Possibility of access to follow-up.
- •Preoperative systemic staging with chest CT, full abdomen CT, brain CT with
- •contrast medium or alternatively brain NMR without and with contrast medium or PET 18FDG and TC
- •brain with contrast medium or MRI (performed within 90 days prior to randomization).
- •Interval between surgery and start of treatment not exceeding 60 days
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Metastatic disease for pre-operative investigations.
- •cN3 finding at pre-surgery staging exams.
- •Patients undergoing neoadjuvant chemotherapy (pre-surgery).
- •Respiratory function tests (PFR) with FEV1 <1.5 liters or DLCO <50% predicted.
- •Chronic hepatic failure in stage B and C according to Child-Pugh classification.
- •Grade IV kidney failure (creatinine clearance <30 ml / min).
- •Pregnancy or breastfeeding.
- •allergy to the study drugs or to the excipients used in them
- •formulation
- •One of the following conditions:
- •- Myocardial infarction in the 12 months prior to randomization
- •- Severe congestive heart failure (NYHA class III-IV)
- •- Unstable angina
- •- Cardiomyopathy in progress
- •- Ventricular arrhythmia
- •- Uncontrolled arterial hypertension
- •- Uncontrolled diabetes
- •- Serious psychotic disorders in progress
- •- Severe infection in progress
- •- Any other serious illness that could interfere with the administration
- •of the therapy foreseen by the protocol
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