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NSCLC Relapse Therapy After Surgery and Peri-operative Chemotherapy

2015年2月12日 更新者：Intergroupe Francophone de Cancerologie Thoracique

Comparison of 2 Chemotherapy Regimens in Non-small-cell Lung Cancer (NSCLC) Patients Relapsing After Surgery and Peri-operative Chemotherapy. A Randomized Phase III Study.

Relapses after perioperative chemotherapy and surgery

研究概览

地位

终止

条件

干预/治疗

详细说明

As chemotherapy gains wider acceptance for the treatment of earlier stages of NSCLC, particularly in the adjuvant and neoadjuvant setting, physicians face a growing population of high performance status patients who have relapsed after their first-line chemotherapy. The type of second-line chemotherapy after initial adjuvant or neoadjuvant treatment with a platinum-based regimen remains largely undefined. Some might consider rechallenging patients with a platinum based doublet whereas others might treat these patients with a monochemotherapy (pemetrexed or docetaxel).

Most relapses occurring after perioperative chemotherapy and surgery are non surgical locally advanced relapses or metastatic diseases.

Some differences exist between these post surgical relapses and the progressions occurring after the first line non surgical treatment of a stage III/IV.

  • Patients are most often in a good condition (performance status 0-1).
  • Progression is often asymptomatic and diagnosed in the post surgical follow up.
  • The dose of chemotherapy previously administered is lower than that administered in first line of a stage III/IV.
  • The time between the first line of treatment and the treatment of the relapse is longer.

These differences might be associated with a more chemosensitive disease and thus might be the rationale of using a platinum containing doublet instead of the classical mono chemotherapy docetaxel or pemetrexed.

Thus, the current study has been designed to answer these questions.

研究类型

介入性

注册 (实际的)

88

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 法国
      • Aix En Provence、法国
        • Centre Hospitalier
      • Ambilly、法国、74100
        • Annemasse - CH
      • Annecy、法国、74374
        • Annecy - CH
      • Auxerre、法国、89011
        • Auxerre - CH
      • Auxerre、法国、89000
        • Auxerre - Polyclinique
      • Bayonne、法国
        • CH de la Côte Basque
      • Beauvais、法国、60021
        • Beauvais - CH
      • Besancon、法国、25000
        • CHU Besancon - Pneumologie
      • Blois、法国、41016
        • Blois - CH
      • Bobigny、法国、93000
        • APHP - CHU Avicenne - Oncologie Medicale
      • Boulogne、法国
        • Boulogne - Ambroise Pare
      • Caen、法国、14000
        • Caen - Centre François Baclesse
      • Caen、法国、14000
        • CHU - Pneumologie
      • Calais、法国、62017
        • Calais - CH
      • Cannes、法国
        • CH de Cannes
      • Chambray Les Tours、法国、37170
        • Chambray Les Tours - Clinique Léonard de Vinci
      • Chauny、法国
        • Chauny - CH
      • Chevilly-Larue、法国、94669
        • Chevilly-Larue - CH
      • Cholet、法国
        • Hôpital de Cholet - Pneumologie
      • Clamart、法国、92140
        • Hôpital Percy-Armées - Pneumologie
      • Clermont-Ferrand、法国
        • Hôpitral Gabriel Montpied - Pneumologie
      • Colmar、法国
        • CH
      • Créteil、法国
        • Chi Creteil
      • Dax、法国、40107
        • Dax - CH
      • Dijon、法国、21079
        • Dijon - CHU
      • Epinal、法国、88021
        • Epinal - CH
      • Grenoble、法国
        • CHU
      • Helfaut、法国、62570
        • Saint Omer - CHI
      • La Roche Sur Yon、法国、85925
        • La Roche Sur Yon - CH
      • Le Coudray、法国、28630
        • Chartres - CH
      • Le Mans、法国、72000
        • Le Mans - Centre Hospitalier
      • Limoges、法国、87042
        • Limoges - Hôpital du Cluzeau
      • Longjumeau、法国
        • CH de Longjumeau
      • Lyon、法国
        • Hopital Louis Pradel
      • Lyon、法国、69003
        • Lyon - Clinique Mutualiste
      • Lyon、法国、69000
        • HCL - Croix-Rousse
      • Macon、法国
        • CH de Macon
      • Marseille、法国
        • Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
      • Maubeuge、法国、59600
        • Maubeuge - Polyclinique du Parc
      • Meaux、法国、77100
        • Meaux - CH
      • Mont de Marsan、法国、40000
        • Mont de Marsan - CH
      • Montélimar、法国
        • Centre Hospitalier
      • Moulins、法国、03000
        • Moulins - CH
      • Mulhouse、法国、68000
        • Mulhouse - CH
      • Nancy、法国
        • CHU
      • Nanterre、法国、92014
        • Nanterre - CH
      • Nantes、法国、44805
        • Nantes - Centre René Gauducheau
      • Nevers、法国
        • CH Nevers
      • Nîmes、法国、30900
        • Nîmes - Clinique Valdegour
      • Orléans、法国、45000
        • Orléans - CH
      • Paris、法国
        • Hopital Saint Antoine
      • Paris、法国、75020
        • APHP - Hopital Tenon - Pneumologie
      • Paris、法国
        • GH Paris Saint-Joseph
      • Perpignan、法国、66046
        • Perpignan - Ch
      • Perpignan、法国、66000
        • Centre Catalan d'Onologie
      • Pierre Bénite、法国、69495
        • HCL - Lyon Sud (Pneumologie)
      • Rambouillet、法国
        • Centre Hospitalier
      • Reims、法国、51092
        • Reims - CHU
      • Reims、法国
        • Institut Jean Godinot
      • Rodez、法国、12021
        • Rodez - CH
      • Roncq、法国、59223
        • Roncq - Clinique Saint-Roch
      • Roubaix、法国、59100
        • Roubaix - CH
      • Saint Nazaire、法国、44600
        • Saint Nazaire - Centre Etienne Dolet
      • Saint Quentin、法国、02100
        • Saint Quentin - CH
      • Saint-Brieuc、法国
        • CH de Saint-Brieuc
      • Saint-Malo、法国、35403
        • Saint-Malo - CH
      • Saint-priest En Jarez、法国、42271
        • Institut de Cancérologie de la Loire
      • Strasbourg、法国、63000
        • CHU Lyautey - Pneumologie
      • Suresnes、法国
        • Hôpital Foch
      • Thonon、法国
        • Hôpitaux du Léman - Pneumologie et Maladies Infectieuruses
      • Toulon、法国、83000
        • Toulon - CHI
      • Toulouse、法国
        • Toulouse - CHU Larrey
      • Tours、法国、37000
        • Tours - CHU
      • Troyes、法国、10000
        • Troyes - CH
      • Valenciennes、法国、59304
        • Valenciennes - Clinique
      • Vesoul、法国
        • CHI de la Haute-Saône - Pneumologie
      • Vienne、法国、38200
        • Vienne - CH
      • Villejuif、法国、94800
        • Institut Gustave Roussy

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients with histologically or cytologically confirmed inoperable non-small cell-lung cancer not eligible for curative radio-therapy (local or metastatic relapse).
  • Previous history of adjuvant or neoadjuvant chemotherapy (at least 2 full cycles of a platinum containing regimen)
  • Initial stage pT1N0 to pT3N2 (TNM classification 1999), complete resection. T4 tumours (several nodules in the same lobe) and M1 tumours (several nodules in the same lung) N0-2 completely resected are allowed to inclusion. Histological complete response tumours (pT0N0) after neoadjuvant chemotherapy are allowed to inclusion.
  • At least one unidimensionally measurable disease (RECIST criteria) (lesions must have clearly defined margins on X-ray, CT-scan, MRI or ultra-sound (US) examination and should measure at least 1 cm if assessed by CT, MRI or US and at least 2 cm if assessed by X-ray, target lesions should be selected outside a previously irradiated field ). PET scans and ultra sonography are not allowed
  • ECOG Performance status 0 to 1).
  • Patients with adequate biological functions:
  • Written informed consent from patient.
  • The effects of docetaxel, cisplatin and carboplatin on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because docetaxel, cisplatin and carboplatin as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Life expectancy > 12 weeks
  • Patient compliance and geographic proximity that allow adequate follow-up.
  • Patient affiliated to a social insurance program

Exclusion Criteria:

  • Previous treatment with docetaxel.
  • Hypersensitivity to docetaxel, cisplatin, carboplatin or polysorbate 80 (excipient).
  • Previous history of cancer other than Non small cell lung cancer, in situ carcinoma of the uterine cervix and basal cell carcinoma of the skin.
  • Patients previously treated by an investigational agent in the last 30 days.
  • Patient treated with preoperative platin based chemotherapy, achieving a progression of disease after treatment evaluation.
  • Patients non responders to preoperative chemotherapy and whose tumor specimen did not disclose any necrosis nor tumoral modification thus confirming the lack of chemosensitivity to platin based chemotherapy
  • Patient treated with platin based adjuvant chemotherapy, relapsing within the first 6 months after surgery.
  • Patients with a peripheral neuropathy grade CTC >= 2
  • Patients unable to fulfill protocol requirements
  • Serious concomitant morbidity incompatible with the study (at the discretion of the investigator).
  • Relapse within the month following lung cancer resection or adjuvant chemotherapy
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • Significant loss of weight (> 10 %) in the 6 weeks preceding patient selection.
  • Concomitant administration of another anti cancer treatment
  • Pregnant women are excluded from this study. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued.
  • Patient under legal protection.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

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：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：一个
药品：Chemotherapy with platine
Docetaxel 75 mg/m² D1 + Cisplatine 75 mg/m² or Carboplatin AUC5 D1 (D1=D22, 4 cycles) Docetaxel 75 mg/m² D1 (D1=D22, 2 cycles if disease control)
有源比较器：B
Docetaxel monotherapy
药品：Chemotherapy without Cisplatine
Docetaxel 75 mg/m² D1 (D1=D22, 4 cycles) Docetaxel 75 mg/m² D1 (D1=D22, 2 cycles if disease control)

研究衡量的是什么？

主要结果指标

结果测量
大体时间
无进展生存期（PFS）
大体时间：一年
一年

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Intergroupe Francophone de Cancerologie Thoracique

调查人员

  • 首席研究员：Denis Moro-Sibilot, Pr、University Hospital, Grenoble

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年9月1日

初级完成 (实际的)

2014年11月1日

研究完成 (实际的)

2014年11月1日

研究注册日期

首次提交

2007年9月25日

首先提交符合 QC 标准的

2007年9月25日

首次发布 (估计)

2007年9月26日

研究记录更新

最后更新发布 (估计)

2015年2月16日

上次提交的符合 QC 标准的更新

2015年2月12日

最后验证

2015年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IFCT-0702

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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