Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 9
- 主要终点
- the evaluation of the clinical response rate of neo-adjuvant chemotherapy with dose-dense therapy of paclitaxel and cisplatin(PC) with peg-filgrastim in patients with operable NSCLC
研究概览
简要总结
A single arm, open-label phase II is appropriate to evaluate the efficacy and safety of dose - dense combination of paclitaxel with cisplatin supported by pegfilgrastim for neo-adjuvant chemotherapy in this patient population.
详细描述
This is an open-label, single-arm Phase II study of dose-dense regimen with paclitaxel and cisplatin supported by pegfilgrastim as neo-adjuvant chemotherapy in patients with operable stage II, IIA NSCLC.
Paclitaxel will be administered via intravenous infusion over approximately 3 hours at dose of 175mg/m2 on Day 1 of each 14-day cycle. Cisplatin 75mg/m2 will be given via intravenous infusion on day 1 (after paclitaxel) according to institutional guidelines.
Pegfilgrastim (Neulasta) fixed dose of 6mg (0.6mL of a 10mg/mL solution) as a single subcutaneous injection on Day 2 of each study cycle.
All drugs will be given in 2-weekly cycle. Three cycles of pre-operative chemotherapy are planned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologic or cytologic diagnosis of NSCLC
- •Presence of clinical Stage IIA,IIB or IIA disease
- •tumor amenable to curative surgical resection
- •Patients with clinically measurable lesions will be enrolled in this study.
- •No prior tumor therapy
- •Performance status of 0-1 on ECOG Scale
- •Patients compliance and geographic proximity that allow adequate follow-up.
- •Medical fitness of patient, including respiratory function, adequate for radical NSCLC surgery.
排除标准
- •Presence of clinical Stage IIIA disease, according to the revision by Mountain CF of American Joint Committee on Cancer.
- •Treatment within the last 30 days with any investigational drug.
- •Cocurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy.
- •Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
- •pregnancy/breast feeding
- •Serious concomitant disorders that would compromise the safety of the patient or compromise the patients ability to complete the study, at the discretion of the investigator.
- •poorly controlled diabetes mellitus
- •Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- •History of significant neurological or mental disorder, including seizures or dementia.
结局指标
主要结局
the evaluation of the clinical response rate of neo-adjuvant chemotherapy with dose-dense therapy of paclitaxel and cisplatin(PC) with peg-filgrastim in patients with operable NSCLC
次要结局
- - disease free survival
- >To evaluate the safety of neo-adjuvant chemotherapy with PC
- - to characterize the toxicity of PC, include febrile neutropenia.
- - to evaluate peri- and post-operative mortality
- > to determine the pathological complete response rate
- > to determine the complete tumor resection rate
- > to evaluate proportion of cycle 2 and all cycles chemotherapy given with planned dose-on-time and proportion of patients receiving planned dose-on-time in cycle 2 and over all cycles.
- > To evaluate the following time-to-event efficacy variables:
- - overall survival
- > to evaluate Quality of life (EORTC QLQ-C30 and QLQ-LC13)