NCT01635270已完成2 期
Randomized Phase 2 Study Evaluating the Interest of Mid-position Strategy Versus ITV (Internal Target Volume) Strategy in Radiotherapy Treatment for Patients With a Locally Advanced Non-resected Non-small Cell Lung Carcinoma (NSCLC).
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- 1 year Progression Free Survival rate
研究概览
简要总结
The purpose of this study is to establish on the market and to clinically evaluate a new strategy of treatment for patients with locally advanced non-small cell lung cancer using deformable repositioning of 4D imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with a NSCLC, non-resected, non-metastatic including a parenchyma portion
- •Age >= 18 years
- •CT-scan within 3 months at inclusion
- •PET-scan within 3 months at inclusion
- •Respiratory functional exploration within 3 months at inclusion
- •estimated V20 (by radiotherapist)< 35% on conventional pre-radiotherapy imaging
- •Tumor T0 to T4, M0; N1, N2 ou N3 by isolateral supra-clavicular involvement
- •Measurable disease according to RECIST criteria 1.1
- •Curative intent Chest conventional radiation therapy
- •Radiation indication validated by a multidisciplinary meeting
- •Adequate contraceptive method for the whole study duration and for up to 28 days after the end of radiation
- •Mandatory affiliation with a health insurance company
- •Patients must provide dated & written consent
排除标准
- •Prior surgery for NSCLC
- •NSCLC nearby pulmonary apex or strictly intra-thoracic with no intra-parenchyma portion
- •Metastatic disease or N3 contralateral lymph node
- •History of chest irradiation
- •History of known increased intrinsic radiosensibility
- •Hypersensibility to active substance or excipient of fluoro-deoxyglucose-18F
- •Life expectancy < 6 months
- •Patient with a concurrent malignancy or with a history of malignancy (excepted adequately treated basal cell skin carcinoma or cervical squamous cell carcinoma or other malignancies free of the disease for at least 5 years)
- •Pregnant or breastfeeding women
- •Psychological, sociological or geographical conditions that would limit compliance with study requirements
- •Patient deprived of freedom
- •Patient has concomitant participation to an other investigational study
结局指标
主要结局
1 year Progression Free Survival rate
时间窗: 1 year
Efficacy evaluation of the midP strategy in comparison with ITV strategy in patient with locally advanced, non-resected NSCL cancer treated with radiotherapy
次要结局
- Local tumor control rate(1 year and 2 years after the end of irradiation)
- Overall survival(1 year and 2 years post irradiation)
- To determine acute and late pulmonary toxicity in the 2 arms, including respiratory functional exploration(Week1; Week 2; Week3; Week4; Week5; Week6; Week7 during the radiation, then 4 weeks, 3 months; 6 months ,one year and 2 years after the irradiation beginning)
研究者
研究点 (2)
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