TAilored Post-Surgical Therapy in Early Stage NSCLC (TASTE)
Randomized Phase II/III Adjuvant Trial Evaluating Feasibility of Standard (A) vs. Customized Treatment (B) in Stage II or Stage IIIA Non-N2, Non-squamous Non Small Cell Lung Cancer (NSCLC).
Our hypothesis is that patients receiving therapy based on their baseline tumor ERCC1 levels and EGFR mutations would attain better disease free survival rates than patients in the control arm receiving noncustomized therapy. Using this selective approach, patients with stage II and IIIA non N2 NSCLC in the genotypic arm with low ERCC1 levels will receive cisplatin plus pemetrexed, and those with high ERCC1 levels will not receive cisplatin-based chemotherapy. If they harbor EGRF mutations they will be treated with erlotinib.
The study will be restricted to non-squamous NSCLC for two mains reasons. First, this will enrich the EGFR mutation rate that is awaited to be higher in these tumors than in squamous cell carcinoma. Second, permetrexed cisplatin combination has a promising efficacy and favorable toxicity profile and is of potential interest in the adjuvant setting of resected non-squamous NSCLC.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
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Aix en Provence、法国
- Centre Hospitalier
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Amiens、法国
- Clinique de l'Europe
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Angers、法国、49000
- Angers - CHU
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Béziers、法国
- Centre Hospitalier
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Caen、法国、14000
- Centre F. Baclesse
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Caen、法国、14000
- CHU - Pneumologie
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Chauny、法国
- Centre Hospitalier
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Chevilly Larue、法国
- Chevilly Larue - CH
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Clamart、法国、92140
- Hôpital Percy-Armées - Pneumologie
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Clermont Ferrand、法国、63000
- Clermont Ferrand - CHU
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Colmar、法国、68000
- Colmar - CH
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Dax、法国、40107
- Dax - CH
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Ermont、法国
- Ermont - Clinique Claude Bernard
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Grenoble、法国、38000
- CHU Grenoble - pneumologie
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Le Mans、法国
- Le Mans - CHG
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Lyon、法国、69000
- Centre Léon Bérard
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Lyon、法国
- Lyon - Hôpital Louis Pradel (Pneumologie)
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Mantes La Jolie、法国、78200
- Mantes La Jolie - CH
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Marseille、法国
- Institut Paoli Calmette
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Marseille、法国、13000
- APHM - Hôpital Sainte Marguerite
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Metz、法国
- Metz - Belle Isle
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Mont de Marsan、法国、40000
- Mont de Marsan - CH
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Montpellier、法国、34070
- Montpellier - Clinique Clémentville
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Mulhouse、法国、68000
- Mulhouse - CH
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Nancy、法国
- Nancy - Polyclinique Gentilly
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Nevers、法国、58033
- Nevers - CH
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Paris、法国、75000
- Paris - Saint Louis
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Paris、法国、75020
- APHP - Hopital Tenon - Pneumologie
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Pau、法国、64046
- Pau - CH
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Pierre Bénite、法国、69495
- HCL - Lyon Sud (Pneumologie)
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Reims、法国、51092
- Reims - CHU
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Rennes、法国
- Rennes - CHU
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Saint-Quentin、法国
- Centre Hospitalier
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Strasbourg、法国、63000
- Nouvel hopital civil
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Suresnes、法国
- Hôpital Foch
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Toulon、法国
- Centre Hospitalier Intercommunal
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Toulouse、法国
- CHU Toulouse - Pneumologie
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Toulouse、法国
- Clinique Pasteur
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Tours、法国、37000
- Tours - CHU
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Vandoeuvre lès Nancy、法国、54500
- Nancy - CHU
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Villejuif、法国、94805
- Institut Gustave Roussy
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Villeneuve-Saint-Georges、法国
- Centre Hospitalier Intercommunal
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- NSCLC that is defined as other than predominantly squamous cell histology (squamous cell and/or mixed small cell, non-small cell histology is not permitted)
- Surgically resected NSCLC with pathological stage II or stage IIIA non-N2 (TNM classification 2008)
- Performance status (PS) = 0 or 1
- 18 years <= age < 70 years
- Signed inform consent
Exclusion Criteria:
- Squamous cell carcinoma
- Previous cancer excepted those treated for more than 5 years and considered cured, basocellular skin carcinoma, carcinoma in situ of uterine cervix
- Inadequate renal or cardiac functions
- Pregnant women
- Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, grade ≥ 2 peripheral neuropathy, peptic ulcer disease, erosive esophagitis or gastritis
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：A
Standard chemotherapy
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Pemetrexed Cisplatin Schedule : CDDP 75 mg/m² D1, pemetrexed 500 mg/m² D1 D1=D21, 4 cycles
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实验性的：B
Customized treatment
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Mutated EGFR : Erlotinib 150mg/day (1 year) Wild-type EGFR or "undetermined" depends on ERCC1 status :
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Feasibility (% of patients having started the treatment before 2 months after the surgery, with the biological results EGFR and ERCC1)
大体时间：week
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week
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Disease-free Survival
大体时间：month
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month
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合作者和调查者
调查人员
- 首席研究员：Jean-Charles SORIA, Pr、Institut Gustave Roussy (Igr)
- 首席研究员：Marie Wislez, Pr、APHP - Hôpital Tenon (Paris)
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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