Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer
- Conditions
- Advanced Non Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT01631136
- Lead Sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Brief Summary
In France, lung cancer is responsible for more than 30000 each year. Progress was made in treatment of lung cancer in the last five years due to targeted therapies and to strategical evolutions consisting in a best adjustment of treatments. Maintenance strategies is one of this strategical evolution. It is based on maintaining continuous therapeutical pression in order to preserve the therapeutical benefit obtained by the first line (induction chemotherapy). Several clinical trials showed that maintenance strategies increase the duration of controlled disease.
There is two types of maintenance strategies:
* Continuous maintenance : prolongation of the treatment initially associated with platin until progression
* Switch maintenance : introduction of a new treatment after the end of induction chemotherapy
The aim of this study is to compare two maintenance strategies
* A continuous maintenance by pemetrexed
* A switch maintenance or a continuous maintenance according to the response of induction chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 932
- Non-squamous NSCLC histologically or cytologically confirmed
- Stage IV with a cytologically or histologically confirmation for an unique metastasis
- No EGFR activating mutation or indeterminate EGFR mutational status
- At least one measurable lesion
- Age between 18 and 70
- PS 0 or 1
- squamous cell lung cancer, small cell lung cancer , neuroendocrine cell lung cancer
- Knowledge of ALK gene rearrangement
- Symptomatic central nervous system metastases or requiring immediate cerebral radiotherapy
- Superior venous cave syndrome except if treated by implantation of a prosthesis
- Previous anti-tumoral treatment
- Concomitant radiotherapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Maintenance according to the response of induction Gemcitabine Induction chemotherapy by cisplatin + gemcitabine followed by : * continuous maintenance therapy by gemcitabine if response disease * switch maintenance therapy by pemetrexed if stable disease Continuous maintenance Therapy Cisplatin Induction chemotherapy by cisplatin + pemetrexed and maintenance therapy by pemetrexed Maintenance according to the response of induction Pemetrexed Induction chemotherapy by cisplatin + gemcitabine followed by : * continuous maintenance therapy by gemcitabine if response disease * switch maintenance therapy by pemetrexed if stable disease Continuous maintenance Therapy Pemetrexed Induction chemotherapy by cisplatin + pemetrexed and maintenance therapy by pemetrexed Maintenance according to the response of induction Cisplatin Induction chemotherapy by cisplatin + gemcitabine followed by : * continuous maintenance therapy by gemcitabine if response disease * switch maintenance therapy by pemetrexed if stable disease
- Primary Outcome Measures
Name Time Method Overall survival around 20 months
- Secondary Outcome Measures
Name Time Method Disease free survival Around 5 months Control and response rate After 4 cycles Safety analysis Around 5 months Number of patients with at least one adverse event in each arm and number of adverse events with the relationship, intensity and the cycle of appearance
treatment exposure Around 5 months
Trial Locations
- Locations (89)
CHU
🇫🇷Poitiers, France
CHU Besancon - Pneumologie
🇫🇷Besancon, France
Castelnau Le Lez - Clinique
🇫🇷Castelnau, France
La Roche Sur Yon - CH
🇫🇷La Roche Sur Yon, France
Colmar - CH
🇫🇷Colmar, France
Clinique Claude Bernard
🇫🇷Albi, France
CH Chambery
🇫🇷Chambery, France
Caen - Centre François Baclesse
🇫🇷Caen, France
Béziers - CH
🇫🇷Béziers, France
Annecy - CH
🇫🇷Annecy, France
Hôpital Privé d'Antony
🇫🇷Antony, France
CH
🇫🇷Cholet, France
Cahors - CH
🇫🇷Cahors, France
CHI Créteil
🇫🇷Créteil, France
Le Mans - Centre Hospitalier
🇫🇷Le Mans, France
Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
🇫🇷Marseille, France
CH de Macon
🇫🇷Macon, France
Lyon - Hôpital Jean Mermoz
🇫🇷Lyon, France
GH Paris Saint-Joseph
🇫🇷Paris, France
Orléans - CH
🇫🇷Orléans, France
Strasbourg - NHC
🇫🇷Strasbourg, France
CHI de la Haute-Saône - Pneumologie
🇫🇷Vesoul, France
Thonon les bains - CH
🇫🇷Thonon les bains, France
Pau - CH
🇫🇷Pau, France
Pontoise - CH
🇫🇷Pontoise, France
Roubaix - CH
🇫🇷Roubaix, France
Valenciennes - Clinique
🇫🇷Valenciennes, France
CH de Villefranche - Pneumologie
🇫🇷Villefranche, France
Argenteuil -CH
🇫🇷Argenteuil, France
Beauvais - CH
🇫🇷Beauvais, France
Aubenas - CH
🇫🇷Aubenas, France
CH de la Côte Basque
🇫🇷Bayonne, France
Hôpital Ambroise Paré - Pneumologie
🇫🇷Boulogne, France
CH de Cannes
🇫🇷Cannes, France
Charleville-Mézières - CH
🇫🇷Charleville-Mézières, France
Centre Hospitalier
🇫🇷Montélimar, France
Hôpital Percy-Armées - Pneumologie
🇫🇷Clamart, France
Creil - GHPSO
🇫🇷Creil, France
CH de Dax
🇫🇷Dax, France
Centre d'Oncologie du Parc
🇫🇷Dijon, France
Centre Georges François Leclerc
🇫🇷Dijon, France
Grenoble - CHU
🇫🇷Grenoble, France
Draguignan - CH
🇫🇷Draguignan, France
Saint Omer - CHI
🇫🇷Helfaut, France
CH de Jonzac
🇫🇷Jonzac, France
CHU (Hôpital Calmette) - Pneumologie
🇫🇷Lille, France
Lille - GHPSO
🇫🇷Lille, France
Limoges - Hôpital du Cluzeau
🇫🇷Limoges, France
CH de Longjumeau
🇫🇷Longjumeau, France
Maubeuge - Polyclinique du Parc
🇫🇷Maubeuge, France
Centre Léon Bérard
🇫🇷Lyon, France
CH Saint Joseph Saint Luc
🇫🇷Lyon, France
Mont de Marsan - CH
🇫🇷Mont de Marsan, France
Mulhouse - CH
🇫🇷Mulhouse, France
Montpellier - Clinique Clémentville
🇫🇷Montpellier, France
Nancy - polyclinique Gentilly
🇫🇷Nancy, France
CHU Nancy
🇫🇷Nancy, France
Paris - Saint Louis
🇫🇷Paris, France
Hopital Tenon - Pneumologie
🇫🇷Paris, France
Hôpital Bichat - Claude - Bernard
🇫🇷Paris, France
HCL - Lyon Sud (Pneumologie)
🇫🇷Pierre Bénite, France
Paris - Curie
🇫🇷Paris, France
Quimper - CH
🇫🇷Quimper, France
Reims - CHU
🇫🇷Reims, France
Institut Jean Godinot
🇫🇷Reims, France
Saint Quentin - CH
🇫🇷Saint Quentin, France
Rennes - CHU
🇫🇷Rennes, France
Saint-Cloud - Centre René Huguenin
🇫🇷Saint-Cloud, France
Sens - CH
🇫🇷Sens, France
Toulon - CHI
🇫🇷Toulon, France
Toulon - HIA
🇫🇷Toulon, France
Toulouse - CHU Larrey
🇫🇷Toulouse, France
Tourcoing - CH
🇫🇷Tourcoing, France
Versailles - CH
🇫🇷Versailles, France
Hôpital de la Croix Rousse
🇫🇷Lyon, France
Centre Hospitalier du Pays d'Aix
🇫🇷Aix-en-Provence, France
Abbeville - CH
🇫🇷Abbeville, France
Annemasse - CH
🇫🇷Ambilly, France
Angers - CHU
🇫🇷Angers, France
Caen - CHU Côte de Nacre
🇫🇷Caen, France
Meaux - CH
🇫🇷Meaux, France
Nice - CAC
🇫🇷Nice, France
Nevers - CH
🇫🇷Nevers, France
HIA Val-de-Grâce
🇫🇷Paris, France
Saint Priest en Jarez - ICL
🇫🇷Saint Priest en Jarez, France
Salon de Provence - CH
🇫🇷Salon de Provence, France
Centre Hospitalier Intercommunal
🇫🇷Villeneuve-Saint-Georges, France
Tours - CHU
🇫🇷Tours, France
Hôpital Louis Pradel
🇫🇷Lyon, France