DRKS00010244招募中1 期
Dose-intensified neoadjuvant radiochemotherapy for operable locally advanced NSCLC Stage III A & B - NEOAHA-I
niversitätsklinikum Essen0 个研究点目标入组 35 人开始时间: 2016年4月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Histopathologically proven non-small cell lung cancer. Biopsy must be taken from either primary tumour or regional lymph node.
- •At the time of initial diagnosis before any treatment, patients must be clinical stage IIIA [T1-3 N2, T4 N0-1, all M0] or IIIB [T4 N2, T1-3 N3, all M0, UICC, 7. ed.] with one or more of the following criteria:
- •T1-T4 tumour, proven by endoscopy or mediastinoscopy or CT or MRI.
- •N2 or N3 mediastinal lymph node involvement, histopathologically or cytopathologically verified by either transbronchial fine-needle aspiration (EBUS-TBNA) or mediastinoscopy. T4 N3 stages are to be excluded (see below).
- •For enrollment in Neo1, patients must have been deemed potentially resectable by an interdisciplinary tumour board (comprising medical oncologist, radiation oncologist, thoracic surgeon) within four months before study inclusion.
- •For enrollment in Def0-3, patients should have been either primarily selected for definitive chemoradiotherapy by the interdisciplinary tumour board or have personally voted against neoadjuvant treatment followed by resection, respectively. Reasons for preference of definitive chemoradiation are: tumour is not resectable with acceptable risk, or the cost-benefit comparison between resection and definitive chemoradiation is worse for surgery.
- •18F-FDG-PET/CT is mandatory before mediastinoscopy and treatment start.
- •Brain imaging (MRI or CT) before treatment start is mandatory.
- •Patients must at least undergo 2 cycles of the specified induction chemotherapy. Following these, a restaging PET/CT within three weeks of radiotherapy treatment planning is mandatory to exclude distant metastases.
- •Patients with chronic obstructive pulmonary disease are eligible.
- •Patients must have FEV1 = 1.2 l and no dyspnea or hypoxia = grade 2 (CTC).
- •Patients with Acquired Immune Deficiency Syndrome (AIDS) or equivalent immune-compromising diseases are eligible when their condition is stable and they are able to undergo a combined chemoradiotherapy regimen.
- •Karnofsky Performance Status 80 - 100% at the time of study inclusion.
- •Age = 18 y
- •Written informed consent
排除标准
- •Patients who are not treatable within normal tissue dose-volume constraints of the protocol.
- •Any component of small-cell histology.
- •Stage T4 N3
- •Pleural effusion, larger than minimal or exsudative, or cytologically proven malignant.
- •Malignant pericardial effusion
- •Distant metastases at initial diagnosis or detected on restaging PET/CT
- •acute infection requiring specific treatment > 10 days
- •Pregnancy or breast feeding. In women of childbearing potential, pregnancy must be excluded before treatment.
- •Patients must be willing to use medically acceptable forms of contraception, otherwise will be excluded.
- •Other invasive malignancies, except for non-melanomatous skin cancer (controlled for at least 5 years).
- •Prior radiotherapy to the region of the study cancer, precluding high-dose irradiation.
- •Insufficient patients’ compliance, e.g. due to active psychiatric disorders or language barriers.
研究者
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