JPRN-jRCTs031180402已完成2 期
A randomized phase II trial of induction CDDP + PEM + BEV versus CDDP + PEM with concurrent radiotherapy followed by surgical resection in patients with pathologically confirmed stage III A-N2 non-squamous-cell non-small cell lung cancer.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Suzuki Kenji
- 入组人数
- 88
研究概览
简要总结
Although not significant, the 2-year progression-free survival rate was higher in the thoracic radiotherapy arm than in the bevacizumab arm. Fatal surgical complications were only observed in the bevacizumab arm. Therefore, pemetrexed-cisplatin with concurrent thoracic radiotherapy was chosen as the investigational induction treatment strategy for future phase III trials.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •(1) Histologically or cytologically proven non-squamous non-small cell lung cancer, diagnosed using specimen material obtained from primary tumor or metastastatic lymph node
- •(2) Stage IIIA- pathologically proven N2 disease
- •(3) Without previously treatment for lung cancer
- •(4) 20years or more, 75 years or less
- •(5) ECOG PS 0-1
- •(6) Expected FEV 1.0 > 800ml after lung resection , SpO2 (Room air) >95%
- •(7) Adequate organ function
- •(8) Written informed consent
排除标准
- •(1) Uncontrollable systemic disease (hyper tension, diabetes mellitus etc.)
- •(2) Current history of hemosputum or hemoptysis
- •(3) Evidence of bleeding diathesis or coagulopathy
- •(4) Cavity in lung tumor or great vessel involvement
- •(5) Current or previous (within the last 1 year) history of cerebrovascular disease
- •(6) Traumatic fracture of un recovery
- •(7) History of active infection
- •(8) hepatitis B surface antigen positive
- •(9) Therapeutic anticoagulation; regular use of aspirin (>325 mg/day)
- •(10) Severe GI disease
- •(11) Current or previous (within the last 1 year) history of GI perforation or diverticultis
- •(12) History of severe heart disease
- •(13) Severe diarrhea
- •(14) Severe drug allergy
- •(15) Investigational new drug or the unapproved drug is administered
- •(16) Interstitial pneumonia or pulmonary fibrosis detectable on chest Xp
- •(17) History of active double cancer
- •(18) History of pregnancy or lactation
- •(19) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator
研究者
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