NL-OMON41422招募中2 期
Treatment of larger tumor volumes or >= 2 lung tumors simultaneously in lung cancer patients using SBRT in a mean-lung dose escalation study - Irradiation of large lung tumors or >= two lung tumors
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 35 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria for riskgroup A and B
- •- Weight loss < 10% in the last three months
- •- WHO-performance status <= 2 (see Appendix II)
- •- Medical inoperable patients or patients refusing surgery
- •- Chemotherapy is allowed in neoadjuvant and adjuvant setting, with exclusion of the period 4 weeks pre-SBRT and 6 weeks post-SBRT.
- •- Before patient registration, written informed consent must be given according to ICH/GCP, national and local regulations (see section 11.3).
- •- Check of inclusion by PI (h.peulen@nki.nl and j.belderbos@nki.nl*) by sending
- •oScreenshot of CT-thorax with tumor location
- •oCase summary
- •oTreatment plan
- •Risk group A specification (large lung tumors):
- •- NSCLC (Cytological or histological proven) patients with one peripheral tumor >5 cm with tumor staging cT2bN0M0 or cT3N0M0 (chest wall infiltration is no exclusion criteria, as long as the tumor diameter is > 5 cm).
- •- In patients without cytological or histological confirmation of NSCLC, a growing FDG-PET positive lesion (SUV >5) is accepted if a contra-indication for invasive diagnostic examination (or refusal) is present
- •- Or a single peripheral lung metastasis in inoperable patients with a diameter of > 5 cm. In case of first presentation of metastatic disease, cytological or histological proof is obligated.
- •Risk group B specification (lung metastases):
- •- Patients with 2 peripheral lprimary NSCLC <= 5 with tumor staging cT1-2aN0M0 (cytological/histological proven or growing and PET positive as described in section 5.2.2)
- •- Patients having two or more peripheral lung tumors without unacceptable dose overlap
- •- Or patients with >= 2 peripheral lung metastases <= 5 cm of any origin at any location in the lung. In case of first presentation of metastatic disease, cytological or histological proof is obligated. This is not necessary in case of a history of an already proven disseminated disease.
排除标准
- •- patients with more lung tumors/metastases who will very likely be retreated within 6 months
- •- Patients with central tumors
- •- Pancoast tumors
- •- Prior radiotherapy treatment to the thorax.
- •- Patients previously treated with adriamycin agents in case of heart involvement within the treatment field
- •- FEV1 and DLCO less than 40 % of the age-adjusted normal value
- •- patients receiving any systemic treatment
- •- pregnancy
- •- patients receiving Bevacizumab within 3 months prior to SBRT or within 1 month post SBRT.
研究者
相似试验
已完成
1 期
Irradiation of Large Lung Tumors or Two or More Lung Metastases SimultaneouslyMetastatic Lung CancerLung CancerNCT01543672The Netherlands Cancer Institute62
尚未招募
不适用
Improving Prediction of Outcomes from Lung Cancer Surgery Using Quantitative Computed Tomographyon-small cell lung cancerChronic obstructive pulmonary diseaseCancer - Lung - Non small cellRespiratory - Chronic obstructive pulmonary diseaseRespiratory - Other respiratory disorders / diseasesEmphysemaNon-small cell lung cancerACTRN12613001141730The Prince Charles Hospital50
进行中（未招募）
不适用
ocal cytoreductive treatments for men with newly diagnosed metastatic prostate cancer in addition to standard of care treatmentProstate cancerCancerISRCTN58401737Imperial College London and Imperial College Healthcare NHS Trust399
招募中
不适用
Feasibility and efficacy of moderate-intensity stereotactic body radiotherapy for ultracentral lung cancerNeoplasmsKCT0006736Korea University Ansan Hospital50
招募中
不适用
Diagnosis of lung nodule and lung cancer on screening chest radiographs: Comparative clinical trial for evaluation of artificial intelligence-integrated PACS versus conventional PACSDiseases of th respiratory systemKCT0005051Seoul National University Hospital84,000