A Phase II Study of Concurrent Nab-Paclitaxel, Carboplatin and Thoracic Radiotherapy in Local Advanced Squamous Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- tumor response rate
研究概览
简要总结
Nab-paclitaxel and carboplatin showed better treatment response compared with cremophor-based paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer, especially for squamous cell cancer. The regimen of weekly nab-paclitaxel, carboplatin and concurrent radiotherapy was well tolerated in a phase I study. Given nab-paclitaxel, carboplatin and concurrent radiotherapy in patients with local advanced squamous cell lung cancer may have promising result.
详细描述
This study was conducted to explore the efficacy and toxicity of concurrent chemoradiotherapy with nab-paclitaxel, carboplatin and thoracic radiotherapy in unresectable local advanced squamous cell lung cancer. Patients will be given nab-paclitaxel weekly at a dose of 60mg/m2, in combination with carboplatin (AUC 2) weekly during concurrent chemoradiotherapy. Thoracic radiation was administered at a dose of 66 Gy/33 fractions, both 3 dimensional conformal and intensity modulated radiation therapy are allowed. Two cycles of consolidation therapy with full dose nab-paclitaxel (260 mg/m2 on day 1) and carboplatin (AUC 6 on day 1) every 21 day will be delivered.
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
- •Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
- •Previously untreated, histological documented, inoperable stage IIIA or IIIB squamous cell carcinoma of lung, excluding those with pericardial, pleural effusion, and those with contralateral hilar or contralateral supraclavicular lymph nodes.
- •Patients must have measurable disease according to RECIST criteria, and all detectable tumor can be encompassed by radiation therapy fields.
- •Weight loss ≦ 5% in the previous six months.
- •Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
- •Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
- •Patients must sign a study-specific informed consent form prior to study entry.
排除标准
- •Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
- •Previous chemotherapy or previous biologic response modifiers for current lung cancer.
- •Patient has previously had thoracic radiation therapy.
- •Prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for five years or more.
- •Serious concomitant disorders that would compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator.
- •History of significant neurological or mental disorder, including seizures or dementia.
研究组 & 干预措施
chemoradiotherapy
This is a single arm study with patients receiving nab-paclitaxel, carboplatin and thoracic radiotherapy.
干预措施: Paclitaxel for Injection（Albumin Bound） (Drug)
chemoradiotherapy
This is a single arm study with patients receiving nab-paclitaxel, carboplatin and thoracic radiotherapy.
干预措施: carboplatin (Drug)
chemoradiotherapy
This is a single arm study with patients receiving nab-paclitaxel, carboplatin and thoracic radiotherapy.
干预措施: thoracic radiation therapy (Radiation)
结局指标
主要结局
tumor response rate
时间窗: one month after the end of all treatment
次要结局
- progression-free survival(2 years from patient enrollment)
- overall survival(2 years from patient enrollment)
- esophagitis(6 mouths from the initiation of treatment)
研究者
Shenglin Ma
President of the hospital
First People's Hospital of Hangzhou