JPRN-jRCTs061180046已完成2 期
Phase II study of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia - IP002
Katakami Nobuyuki0 个研究点目标入组 21 人开始时间: 2019年3月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
研究概览
简要总结
Combination of carboplatin, paclitaxel and bevacizumab is a promising treatment for non-squamous, non-small cell lung cancer with idiopathic interstitial pneumonitis.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)Non-squamous, non-small cell lung cancer
- •2)No prior radiotherapy to primary tumor
- •3)Age over twenty
- •4)Idiopathic interstitial pneumonia
- •5)Measurable lesion
- •6)The following procedures or operations should be completed before protocol treatment
- •1.major surgery (including exploratory thoracotomy): more than 4 weeks
- •2.chest tube drainage: more than 2 weeks
- •3.incisional biopsy or treatment of injury: more than 2 weeks
- •4.bronchoscopic tumor biopsy, bronchoscopic needle aspiration biopsy, or implantation of central venous port: more than 1 week.
- •7) ECOG performance status 0 or 1
- •8) Adequate organ function
- •WBC>=3000/mm3 and neutrophil count >=2000/mm3
- •Hgb>=10.0g/dL, Plt>=100,000/mm3, T-bil=<1.5mg/dL, AST=<100 IU/L, ALT=<100 IU/L, CRN=<1.5mg/dL, proteinuria=<1+, or =< 2g/day
- •9) PaO2>=60.0 torr or SpO2>=92.0 % (room air)
- •10) Life expectancy >= 3 months
- •11) Written informed consent
排除标准
- •1) Secondly interstitial pneumonia.
- •2) History of acute exacerbation of interstitial pneumonia within 3 months.
- •3) Subacute progression of interstitial pneumonia within 3 months.
- •4) Using prednisolone or immune-suppressive agent.
- •5) Need to home oxygen therapy.
- •6) Past history of severe drug allergy.
- •7) Active infectious disease.
- •8) Severe complications.
- •9) Symptomatic brain metastasis.
- •10) Uncontrollable effusion.
- •11) Hemoptysis.
- •12) Apparent invasion into great vessels, apparent pulmonary cavitary lesion.
- •13) Active peptic ulcer.
- •14) Bleeding tendency.
- •15) Unhealed major operation wounds.
- •16) Thrombosis.
- •17) Multiple primary cancers with disease-free period less than 2 years, except carcinoma in situ or intra mucosal disease cured by local therapy.
- •18) Any ineligible case judged by physician.
研究者
相似试验
Unknown
2 期
Concurrent Nab-P/Carboplatin and Thoracic Radiotherapy in Squamous Cell Lung CancerCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellNCT01494415First People's Hospital of Hangzhou21
已完成
不适用
Phase II trial of nab-paclitaxel and carboplatin with concurrent radiotherapy for patients with locally advanced non-small cell lung cancernon-small cell lung cancerJPRN-UMIN000019611Department of Radiation Oncology, Yamaguchi University Hospital37
已完成
2 期
Carboplatin and nab-Paclitaxel as first-line treatment in patients with advanced non-small cell lung cancer with interstitial lung disease (HOT1302)on-small cell lung cancerJPRN-UMIN000012901Hokkaido Lung Cancer Clinical Study Group36
已完成
2 期
Nivolumab, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma That Can Be Removed by SurgeryName Human Papillomavirus Positive Oropharyngeal Squamous Cell CarcinomaStage II Oropharyngeal Squamous Cell CarcinomaStage III Hypopharyngeal Squamous Cell CarcinomaStage III Laryngeal Squamous Cell CarcinomaStage III Oral Cavity Squamous Cell CarcinomaStage III Oropharyngeal Squamous Cell CarcinomaStage IV Hypopharyngeal Squamous Cell CarcinomaStage IV Laryngeal Squamous Cell CarcinomaStage IV Oral Cavity Squamous Cell CarcinomaStage IV Oropharyngeal Squamous Cell CarcinomaStage IVA Hypopharyngeal Squamous Cell CarcinomaStage IVA Laryngeal Squamous Cell CarcinomaStage IVA Oral Cavity Squamous Cell CarcinomaStage IVA Oropharyngeal Squamous Cell CarcinomaStage IVB Hypopharyngeal Squamous Cell CarcinomaStage IVB Laryngeal Squamous Cell CarcinomaStage IVB Oral Cavity Squamous Cell CarcinomaStage IVB Oropharyngeal Squamous Cell CarcinomaStage IVC Hypopharyngeal Squamous Cell CarcinomaStage IVC Laryngeal Squamous Cell CarcinomaStage IVC Oral Cavity Squamous Cell CarcinomaStage IVC Oropharyngeal Squamous Cell CarcinomaNCT03342911Sidney Kimmel Cancer Center at Thomas Jefferson University34
招募中
2 期
OGIK2102JPRN-jRCTs071220008Okamoto Isamu52