JPRN-jRCTs041180023已完成3 期
Randomized Phase III Study of Pemetrexed + Cisplatin and Vinorelbine + Cisplatin for Completely Resected Non-squamous Non-Small Cell Lung Cancer - Phase III Study of PEM + CDDP and VNR + CDDP for Completely Resected Non-squamous Non-Small Cell Lung Cancer
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 804
研究概览
简要总结
Although this study failed to show the superiority of pemetrexed plus cisplatin in terms of recurrence-free survival for patients with completely resected nonsquamous NSCLC, toxicity profiles favored this regimen.
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 confirmed non-squamous NSCLC. Adenosquamous carcinoma is eligible if the squamous cell carcinoma component is less than 50%.
- •2) Pathologic stage II or IIIA (UICC TNM Classification 7th edition)
- •3) Proven EGFR gene mutation status (Exon19 deletion/ Exon21 L858R; present/ absent) (regardless of the type of determination method)
- •4) Complete resection* is pathologically confirmed.
- •*Complete resection is the surgical procedure which removes lung cancer to the R0 level.
- •5) The level of surgical resection is higher than lobectomy.
- •6) ND2a-1 or higher-level lymph node dissection or selective lymph node dissection has been conducted.
- •7) No other treatments except surgery have been carried out for lung cancer.
- •8) The age is within 20-75 years inclusive.
- •9) A performance status (ECOG) of 0 or 1.
- •10) Registration was made at 21 or more days after surgery but within 56 days after surgery.
- •11) The functions of the main organs are maintained, and all the criteria stated below are satisfied.
- •(Laboratory test values should be the most recent findings obtained within 14 days before registration, although the findings made 2 weeks previously are acceptable, if they were obtained on the same day of the week as that of the date of registration.)
- •* Hemoglobin: >=9.0 g/dl
- •* WBC: >=3000/mm3 (Neutrophil count: >=1500/mm3)
- •* Platelet count: >=100,000/mm3
- •* Both AST and ALT: <=100 IU/L
- •* Total bilirubin: <=1.5 mg/dl
- •* Serum creatinine: <=1.5 mg/dl
- •* Creatinine clearance: >=60 ml/min (actual measurement or the value obtained using the Cockcroft-Gault formula)
- •12) PaO2: >=70 Torr or SpO2: >=95% in the state of no oxygen inhalation (room climate)
- •13) Submission of written informed consent concerning study participation.
排除标准
- •1) Have active double cancer (synchronous double cancer and metachronous double cancer within a 5-year disease-free interval are defined as active double cancer; in situ uterocervical carcinoma judged to be curable by topical therapy, gastric/colorectal cancer resectable by endoscopy, and topically resectable active skin diseases, except malignant melanoma, are not included in active double cancer); however, a patient is eligible even if double primary NSCLC is observed in the resected lung.
- •2) Previously treated with cisplatin, pemetrexed or vinorelbine
- •3) Administration of folic acid or Vitamin B12 is not possible.
- •4) Serious post-operative complications (post-operative infections, suture failures, etc.)
- •5) Interstitial shadow considered to be clearly indicative of interstitial pneumonia on chest CT
- •6) Active infection
- •7) Requirement of continuous systemic administration (oral or intravenous) of steroid at a dose > 10 mg/day in the case of prednisolone, and the current use of an immunosuppressant; however, patients currently treated with oral steroid at a dose of 10 mg/day in case of prednisolone can be enrolled in the study.
- •8) Women who are currently pregnant or will not be compliant with a medically approved contraceptive regimen during and for 6 months after the treatment period and lactating women.
- •Men who will not be compliant with a contraceptive regimen during and for 6 months after the treatment period.
- •9) History of serious drug hypersensitivity
- •10) Other serious complications
- •11) Others judged by the investigator to be unsuitable for the study
研究者
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