Non-squamous Non-small Cell Lung Cancer Clinical Trial
— UltimateOfficial title:
Phase III Study Comparing the Efficacy of Paclitaxel-bevacizumab With Docetaxel in 2nd or 3rd Line of Treatment of Non Squamous Non Small Cells Lung Cancer
NCT number | NCT01763671 |
Other study ID # | IFCT-1103 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | May 2013 |
Est. completion date | April 2017 |
Verified date | March 2023 |
Source | Intergroupe Francophone de Cancerologie Thoracique |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study objective is to evaluate the efficacy of paclitaxel-bevacizumab comparing to docetaxel. Docetaxel is a standard treatment of 2nd or 3rd line in lung cancer. It was validated by numerous clinical trials but sometimes toxicities are difficult to manage. Bevacizumab is an antiangiogenic treatment which was validated by numerous clinical trials in association with platinum in first ligne. Different clinical and preclinical data suggest that there could exist a synergy between paclitaxel and bevacizumab. This association is already used in metastatic breast cancer, it permits almost to double the response rate and progression free survival. In lung cancer, the association was evaluated by two retrospective studies which demonstrated a benefit with a favourable safety profile.
Status | Completed |
Enrollment | 166 |
Est. completion date | April 2017 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 2nd or 3rd line of non squamous non small cell lung cancer of stage III or IV - Document progression at the time of the inclusion. At least, one previous chemotherapy line with platinum. Patient who had previous treatment with bevacizumab can be included. - Patient with active mutation of EGFR must have had on line of chemotherapy with platinum and one with Tyrosine kinase inhibitor of EGFR. - Patient with ALK rearrangement must have had at least one line of chemotherapy with platinum and one with crizotinib. Exclusion Criteria: - Mixed cancer small cells and non small cells or squamous lung cancer. - Central nervous system symptomatic metastasis or requiring immediate cerebral radiotherapy - patient who have had previous treatment with taxane (docetaxel, paclitaxel). Peri-operatory chemotherapy or chemoradiotherapy with taxane allowed if stopped more than 6 months before. |
Country | Name | City | State |
---|---|---|---|
France | Amiens - CHU | Amiens | |
France | Centre Hospitalier | Annemasse | |
France | Hôpital Privé d'Antony | Antony | |
France | Avignon - Institut Sainte-Catherine | Avignon | |
France | CH de la Côte Basque | Bayonne | |
France | Béziers - CH | Béziers | |
France | Bordeaux - Polyclinique Nord | Bordeaux | |
France | Caen - Centre François Baclesse | Caen | |
France | Caen - CHU Côte de Nacre | Caen | |
France | Castelnau Le Lez - Clinique | Castelnau | |
France | CH de Chartres Hôpital Louis Pasteur | Chartres | |
France | Chauny - CH | Chauny | |
France | CH | Cholet | |
France | Hôpital Percy-Armées - Pneumologie | Clamart | |
France | Hôpitral Gabriel Montpied - Pneumologie | Clermont-Ferrand | |
France | CH | Colmar | |
France | CH Compiègne - Pneumologie | Compiègne | |
France | CHI Créteil | Créteil | |
France | CHRU Grenoble | Grenoble | |
France | Harfleur - Clinique du Petit Colmoulins | Harfleur | |
France | CH Région Saint-Omer | Helfaut | |
France | Le Mans - Centre Hospitalier | Le Mans | |
France | CHU (Hôpital Calmette) - Pneumologie | Lille | |
France | CH de Longjumeau | Longjumeau | |
France | Lorient - CHBS | Lorient | |
France | Lyon - Hôpital Jean Mermoz | Lyon | |
France | Lyon - Hôpital Louis Pradel (Pneumologie) | Lyon | |
France | CH de Macon | Macon | |
France | Mantes La Jolie - CH | Mantes La Jolie | |
France | Marseille - Hôpital Sainte Marguerite | Marseille | |
France | Maubeuge - Polyclinique du Parc | Maubeuge | |
France | CH Montélimar | Montélimar | |
France | Mulhouse - CH | Mulhouse | |
France | Nantes - Centre René Gauducheau | Nantes | |
France | CHR d'Orléans La Source | Orléans | |
France | HIA Val-de-Grâce | Paris | |
France | Hôpital Bichat - Claude - Bernard | Paris | |
France | Hopital Tenon - Pneumologie | Paris | |
France | Paris - Pitié-salpêtrière | Paris | |
France | Paris - Saint Louis | Paris | |
France | Pau - CH | Pau | |
France | Lyon Sud | Pierre Bénite | |
France | Rouen - CHU | Rouen | |
France | Saint Quentin - CH | Saint Quentin | |
France | CHU Saint-Etienne Pneumologie | Saint-Etienne | |
France | Strasbourg - NHC | Strasbourg | |
France | Suresnes - Hopital Foch | Suresnes | |
France | Thonon les bains - CH | Thonon les bains | |
France | Toulon - CHI | Toulon | |
France | Toulon - HIA | Toulon | |
France | Toulouse - CHU Larrey | Toulouse | |
France | Tours - CHU | Tours | |
France | Valenciennes - Clinique | Valenciennes | |
France | CH de Villefranche - Pneumologie | Villefranche | |
France | Institut Gustave Roussy | Villejuif |
Lead Sponsor | Collaborator |
---|---|
Intergroupe Francophone de Cancerologie Thoracique |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression free survival | Time between inclusion and progression | about 4 months | |
Secondary | Response Rate | At 8 weeks | ||
Secondary | Overall survival | Time between inclusion and death | about 8 months |
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