A Phase II Study of Pemetrexed Plus Cisplatin With Concurrent Radiation Therapy Followed by Every-21-Day Docetaxel Consolidation in Patients With Inoperable Stage IIIA/B Squamous Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
To evaluate the efficacy and toxicity of patients with inoperable squamous cell lung cancer treated with pemetrexed plus cisplatin with concurrent radiation therapy followed by docetaxel consolidation. An exploratory biomarker analysis in blood and tumor samples is also planned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed stage IIIA/ IIIB squamous cell lung cancer;
- •All sites of disease must be amenable to definitive radiotherapy;
- •Age 18 years to 75 years;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2;
- •Forced expiratory volume in 1 second(FEV1)> 0.75L;
- •No previous chest radiotherapy, immunotherapy or biotherapy;
- •Adequate bone marrow, liver and renal function, as specified below: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L; Hemoglobin ≥ 8 g/dL; Platelets ≥ 100 x 109/L; Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) ; Aspartate transaminase(AST) and alanine Transaminase(ALT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present; Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal.
- •For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment
- •Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter;
- •Patients and their family signed the informed consents;
排除标准
- •Active infection;
- •History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias);
- •Malnutrition (loss of ≥ 20% of the original body weight);
- •Performance status: 3-4;
- •Sensor or motor neuropathy > grade I;
- •Second primary malignancy, except for non-melanoma skin cancer;
- •Psychiatric illness or social situation that would preclude study compliance;
- •Pregnant or lactating women.
研究组 & 干预措施
pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel
Patients received pemetrexed 500mg/m2 days 1,29+cisplatin 25 mg/m2 days 1-3,29-31 + Radiation 6000 cGy (200 cGy/day). Patients with complete response(CR), partial response(PR) or stable disease(SD) with manageable toxicity received docetaxel 60 mg/m2 days 57,78.
干预措施: pemetrexed (Drug)
pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel
Patients received pemetrexed 500mg/m2 days 1,29+cisplatin 25 mg/m2 days 1-3,29-31 + Radiation 6000 cGy (200 cGy/day). Patients with complete response(CR), partial response(PR) or stable disease(SD) with manageable toxicity received docetaxel 60 mg/m2 days 57,78.
干预措施: cisplatin (Drug)
pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel
Patients received pemetrexed 500mg/m2 days 1,29+cisplatin 25 mg/m2 days 1-3,29-31 + Radiation 6000 cGy (200 cGy/day). Patients with complete response(CR), partial response(PR) or stable disease(SD) with manageable toxicity received docetaxel 60 mg/m2 days 57,78.
干预措施: thoracic radiation therapy (Radiation)
pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel
Patients received pemetrexed 500mg/m2 days 1,29+cisplatin 25 mg/m2 days 1-3,29-31 + Radiation 6000 cGy (200 cGy/day). Patients with complete response(CR), partial response(PR) or stable disease(SD) with manageable toxicity received docetaxel 60 mg/m2 days 57,78.
干预措施: docetaxel (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: 3 years
次要结局
- Rate of CTCAE grade 2 or higher radiation pneumonitis(1 years)
- Overall Survival(3 years)
- Local control rate(3 years)
- The short-term quality of life (QOL) assessed using FACT-E score(4 months)