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Colorectal cancer occurs mainly in elderly patients. Recent estimation showed that in France more than 50% of the patients diagnosed with a colorectal cancer are 70 years old or more. Adjuvant chemotherapy has demonstrated a benefit on disease-free survival and overall survival after a stage III colon cancer resection. Nevertheless adjuvant chemotherapy is poorly used in elderly patients. Prognostic improvement with chemotherapy based on 5FU is suggested by a post-hoc analysis of randomized prospective clinical trial. But elderly patients in this study were highly selected and patients older than 80 represented only 0.7% of the total population. Thus, there is still a concern about the benefit of adjuvant 5FU-based chemotherapy in very elderly unselected patients.
The recommended treatment for stage III adjuvant chemotherapy is a combination of fuoropyrimidine and oxaliplatin. Nevertheless oxaliplatin did not demonstrated survival advantage in elderly patients.
Altogether there are still two matters of debate:
The elderly patient population will be dichotomized into two groups according to physician's choice after a multidisciplinary evaluation involving a geriatrician, with two different randomization assignments. The patients with an expected life-expectancy below 4 years according Lee score are excluded of this study.
Some biological tumour abnormalities are more frequently observed in elderly (i.e. mismatch repair deficiency), therefore an evaluation of specific biological prognostic factors is needed in elderly population.
Colorectal cancer occurs mainly in elderly patients. Recent estimation showed that in France more than 50% of the patients diagnosed with a colorectal cancer are 70 years old or more. Adjuvant chemotherapy has demonstrated a benefit on disease-free survival and overall survival after a stage III colon cancer resection. Nevertheless adjuvant chemotherapy is poorly used in elderly patients. Prognostic improvement with chemotherapy based on 5FU is suggested by a post-hoc analysis of randomized prospective clinical trial. But elderly patients in this study were highly selected and patients older than 80 represented only 0.7% of the total population. Thus, there is still a concern about the benefit of adjuvant 5FU-based chemotherapy in very elderly unselected patients.
The recommended treatment for stage III adjuvant chemotherapy is a combination of fuoropyrimidine and oxaliplatin. Nevertheless oxaliplatin did not demonstrated survival advantage in elderly patients.
Altogether there are still two matters of debate:
The elderly patient population will be dichotomized into two groups according to physician's choice after a multidisciplinary evaluation involving a geriatrician, with two different randomization assignments. The patients with an expected life-expectancy below 4 years according Lee score are excluded of this study.
Some biological tumour abnormalities are more frequently observed in elderly (i.e. mismatch repair deficiency), therefore an evaluation of specific biological prognostic factors is needed in elderly population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP1 -ARM A | Experimental | LV5FU2 or capecitabine |
|
| GROUP1-ARMB | Experimental | FOLFOX4 or XELOX |
|
| GROUP2- ARM C | Experimental | Observation |
|
| GROUP2-ARM D | Experimental | LV5FU2 or capecitabine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LV5FU2 or capectitabine | Drug |
| ||
| FOLFOX4 or XELOX |
| Measure | Description | Time Frame |
|---|---|---|
| The 3-year disease-free survival | 3 years after last patient in |
| Measure | Description | Time Frame |
|---|---|---|
| Overal survival | 5 years after last patient in | |
| Observed toxicities, graded according to NCI-CTC v4 | 3 years after last patient in |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martina Schneider | Contact | +33 3 80 39 34 83 | martina.schneider@u-bourgogne.fr | |
| Jaique Cario | Contact | +33 3 80 39 34 86 | jaique.cario_isat@u-bourgogne.fr |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Aparicio, Pr | FFCD member | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Fort de France | Recruiting | Fort de France | Guadeloupe | 97261 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26748426 | Background | Aparicio T, Francois E, Cristol-Dalstein L, Carola E, Maillard E, Paillaud E, Retornaz F, Faroux R, Andre T, Bedenne L, Seitz JF. PRODIGE 34-FFCD 1402-ADAGE: Adjuvant chemotherapy in elderly patients with resected stage III colon cancer: A randomized phase 3 trial. Dig Liver Dis. 2016 Feb;48(2):206-7. doi: 10.1016/j.dld.2015.11.023. Epub 2015 Dec 2. No abstract available. |
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|
| Observation | Other |
|
| LV5FU2 or capecitabine | Drug |
|
| CH d'Abbeville | Recruiting | Abbeville | 80142 | France |
|
| CROMG | Recruiting | Agen | France |
|
| Centre hospitalier du Pays d'Aix | Recruiting | Aix-en-Provence | 13616 | France |
|
| Centre hospitalier d'Albi | Recruiting | Albi | 81000 | France |
|
| Clinique Claude Bernard | Recruiting | Albi | 81030 | France |
|
| Clinique Claude Bernard | Recruiting | Albi | France |
|
| Centre Oncogard | Recruiting | Alès | 30103 | France |
|
| Hôpital Sud | Recruiting | Amiens | 80054 | France |
|
| ICO Site Paul Papin | Recruiting | Angers | 49055 | France |
|
| CHU d'Angers | Recruiting | Angers | 49933 | France |
|
| HOP Privé | Recruiting | Annemasse | France |
|
| CH Victor Dupouy | Recruiting | Argenteuil | 95107 | France |
|
| Hôpital Les Bonnettes | Recruiting | Arras | 62012 | France |
|
| Hôpital Privé Bonnettes | Recruiting | Arras | France |
|
| Centre Hospitalier Ardèche Méridionale | Recruiting | Aubenas | 07205 | France |
|
| CH D'Auxerre | Recruiting | Auxerre | 89000 | France |
|
| Hôpital Henri Duffaut | Recruiting | Avignon | 84902 | France |
|
| Institut Sainte Catherine | Recruiting | Avignon | 84918 | France |
|
| Hôpital de Bayeux | Recruiting | Bayeux | 14401 | France |
|
| Centre d'Oncologie et de Radiothérapie du Pays-Basque | Recruiting | Bayonne | 64100 | France |
|
| CH Côte Basque | Recruiting | Bayonne | 64109 | France |
|
| CH de Beauvais | Recruiting | Beauvais | 60021 | France |
|
| CH de Béziers | Recruiting | Béziers | 34525 | France |
|
| CH de Blois | Recruiting | Blois | 41000 | France |
|
| CHU Avicenne | Recruiting | Bobigny | 93009 | France |
|
| Polyclinique Bordeaux Nord | Recruiting | Bordeaux | 33077 | France |
|
| Hôpital Duchenne | Recruiting | Boulogne-sur-Mer | 62321 | France |
|
| Hôpital Pierre Oudot | Recruiting | Bourgoin | 38300 | France |
|
| Clinique Pasteur Saint Esprit | Recruiting | Brest | 29200 | France |
|
| CHU Côte de Nacre | Recruiting | Caen | 14033 | France |
|
| CH | Recruiting | Cahors | France |
|
| Infirmerie Protestante de Lyon | Recruiting | Caluire-et-Cuire | 69300 | France |
|
| CH William Morey | Recruiting | Chalon-sur-Saône | 71100 | France |
|
| Hôpital Privé Sainte Marie | Recruiting | Chalon-sur-Saône | 71100 | France |
|
| Centre Hospitalier Métropole Savoie | Recruiting | Chambéry | 73011 | France |
|
| Centre Hospitalier Général | Recruiting | Châlons-en-Champagne | 51005 | France |
|
| Centre Hospitalier Public du Cotentin | Recruiting | Cherbourg | 50102 | France |
|
| CH | Recruiting | Cherbourg | France |
|
| CHU Estaing | Recruiting | Clermont-Ferrand | 63003 | France |
|
| Hopitaux Civils de Colmar | Recruiting | Colmar | 68024 | France |
|
| Centre Hospitalier | Recruiting | Compiègne | 60321 | France |
|
| CH | Recruiting | Contamine-sur-Arve | France |
|
| Centre Hospitalier Sud Francilien | Recruiting | Corbeil-Essonnes | 91106 | France |
|
| Clinique des Cèdres | Recruiting | Cornebarrieu | 31700 | France |
|
| Clinique des Cèdres | Recruiting | Cornebarrieu | France |
|
| Centre Hospitalier de Dax | Recruiting | Dax | 40107 | France |
|
| Service de médecine | Recruiting | Digne-les-Bains | 04000 | France |
|
| Institut de Cancérologie de Bourgogne - GRRECC | Recruiting | Dijon | 21000 | France |
|
| Centre Goerges François Leclerc | Recruiting | Dijon | 21079 | France |
|
| Hôpital François Mitterand | Recruiting | Dijon | 21079 | France |
|
| CHI Elbeuf-Louviers-Val de Reuil | Recruiting | Elbeuf | 76503 | France |
|
| Centre médical des Forcilles | Recruiting | Férolles-Attilly | 77150 | France |
|
| CH | Recruiting | Flers | France |
|
| CHI de Fréjus Saint-Raphaël | Recruiting | Fréjus | 83600 | France |
|
| Centre Hospitalier | Recruiting | Gap | 05007 | France |
|
| Centre Hospitalier | Recruiting | Gonesse | 95500 | France |
|
| CH | Recruiting | Gonesse | France |
|
| CHU de Grenoble - Hôpital A. Michallon | Recruiting | Grenoble | 38043 | France |
|
| CH Marne La Vallée-Jossigny | Recruiting | Jossigny | 77600 | France |
|
| CHD Vendée | Recruiting | La Roche-sur-Yon | 85925 | France |
|
| Groupe Hospitalier de la Rochelle Ré-Aunis | Recruiting | La Rochelle | 17019 | France |
|
| CH | Recruiting | Le Coudray | France |
|
| CH du Mans | Recruiting | Le Mans | 72037 | France |
|
| Centre Oscar Lambret | Recruiting | Lille | 59037 | France |
|
| CHRU Hôpital Claude Huriez 4eme EST | Recruiting | Lille | 59037 | France |
|
| Clinique François Chénieux | Recruiting | Limoges | 87000 | France |
|
| CHU Dupuytren | Recruiting | Limoges | 87042 | France |
|
| CH | Recruiting | Longjumeau | 91164 | France |
|
| CHBS - Hôpital du Scorff | Recruiting | Lorient | 56322 | France |
|
| Clinique Mutualiste Eugène André | Recruiting | Lyon | 69003 | France |
|
| Hôpital Privé Jean Mermoz | Recruiting | Lyon | 69008 | France |
|
| Clinique de la Sauvegarde | Recruiting | Lyon | 69009 | France |
|
| CHU de Lyon - Croix Rousse | Recruiting | Lyon | 69317 | France |
|
| CH ST Joseph-ST Luc | Recruiting | Lyon | 69365 | France |
|
| Hôpital Edouard Herriot | Recruiting | Lyon | 69437 | France |
|
| Hôpital Européen Marseille | Recruiting | Marseille | 13331 | France |
|
| CHU La Timone | Recruiting | Marseille | 13385 | France |
|
| Hopital Nord | Recruiting | Marseille | 13915 | France |
|
| Centre Radiologie | Recruiting | Mâcon | France |
|
| CH de Meaux | Recruiting | Meaux | 77100 | France |
|
| Hôpital Layne | Recruiting | Mont-de-Marsan | 40024 | France |
|
| Centre Hospitalier | Recruiting | Montélimar | 26216 | France |
|
| Hôpital Monod | Recruiting | Montivilliers | 76290 | France |
|
| Centre Hospitalier | Recruiting | Morlaix | 29672 | France |
|
| Centre Azuréen de Cancérologie | Recruiting | Mougins | 06250 | France |
|
| Hôpital Privé du Confluent SAS | Recruiting | Nantes | 44277 | France |
|
| Hôpital Américain de Paris | Recruiting | Neuilly-sur-Seine | 92200 | France |
|
| Hôpital Pierre Bérégovoy | Recruiting | Nevers | 58033 | France |
|
| Centre Antoine Lacassagne | Recruiting | Nice | 06189 | France |
|
| Centre Oncogard | Recruiting | Nîmes | 30029 | France |
|
| CHU Carémeau | Recruiting | Nîmes | 30029 | France |
|
| Hôpital de la Source | Recruiting | Orléans | 45067 | France |
|
| Hôpital Privé des Peupliers | Recruiting | Paris | 75013 | France |
|
| Hôpital Saint Antoine | Recruiting | Paris | 75571 | France |
|
| HEGP | Recruiting | Paris | France |
|
| Hôpital Cochin | Recruiting | Paris | France |
|
| Hôpital Saint Louis | Recruiting | Paris | France |
|
| Institut Montsouris | Recruiting | Paris | France |
|
| Pitié Salpêtière | Recruiting | Paris | France |
|
| Centre Hospitalier | Recruiting | Pau | 64046 | France |
|
| Hôpital Haut Leveque | Recruiting | Pessac | 33604 | France |
|
| Polyclinique Francheville | Recruiting | Périgueux | 24004 | France |
|
| CHU Lyon Sud | Recruiting | Pierre-Bénite | 64495 | France |
|
| Centre CARIO - HCPA | Recruiting | Plérin | 22190 | France |
|
| Hôpital de la Milétrie | Recruiting | Poitiers | 86021 | France |
|
| CH Annecy Genevois | Recruiting | Pringy | 74374 | France |
|
| CHU Robert Debré | Recruiting | Reims | 51092 | France |
|
| CHU de Pontchaillou | Recruiting | Rennes | 35033 | France |
|
| Centre Eugène Marquis | Recruiting | Rennes | 35042 | France |
|
| CH | Recruiting | Rodez | France |
|
| Hôpital Drome Nord | Recruiting | Romans-sur-Isère | 26100 | France |
|
| CHU Charles Nicolle | Recruiting | Rouen | 76031 | France |
|
| Clinique Mathilde | Recruiting | Rouen | 76175 | France |
|
| Institut Curie | Recruiting | Saint-Cloud | 92210 | France |
|
| Hôpital Privé Saint Grégoire | Recruiting | Saint-Grégoire | 35768 | France |
|
| ICO - Site René Gauducheau | Recruiting | Saint-Herblain | 44805 | France |
|
| Polyclinique Côte Basque Sud | Recruiting | Saint-Jean-de-Luz | 64500 | France |
|
| Hôpital d'Instruction des Armées Begin | Recruiting | Saint-Mandé | 94163 | France |
|
| CH Région Saint Omer | Recruiting | Saint-Omer | 62505 | France |
|
| Institut de Cancérologie Lucien Neuwirth | Recruiting | Saint-Priest-en-Jarez | 42271 | France |
|
| Polyclinique Saint Claude | Recruiting | Saint-Quentin | 02100 | France |
|
| CH | Recruiting | Saint-Quentin | France |
|
| CH Saintonge | Recruiting | Saintes | 17108 | France |
|
| CH Morlevat | Recruiting | Semur-en-Auxois | 21140 | France |
|
| CH | Recruiting | Senlis | 60309 | France |
|
| Centre Hospitalier | Recruiting | Sens | 89108 | France |
|
| Centre Hospitalier de Saint-Malo | Recruiting | St-Malo | 35403 | France |
|
| Clinique Sainte Anne | Recruiting | Strasbourg | 67000 | France |
|
| Centre Paul Strauss | Recruiting | Strasbourg | 67065 | France |
|
| Hôpitaux du Leman | Recruiting | Thonon-les-Bains | 74203 | France |
|
| Hôpital Sainte Musse | Recruiting | Toulon | 83000 | France |
|
| Hôpital Sainte Musse | Recruiting | Toulon | 83000 | France |
|
| Clinique Saint Jean du Languedoc | Recruiting | Toulouse | 31077 | France |
|
| Hôpitaux Trousseau | Recruiting | Tours | 37044 | France |
|
| Centre Hospitalier | Recruiting | Valenciennes | 59322 | France |
|
| CHU de Nancy-Bradois | Recruiting | Vandœuvre-lès-Nancy | 54511 | France |
|
| Institut de Cancérologie de Lorraine | Recruiting | Vandœuvre-lès-Nancy | 54519 | France |
|
| Paul Brousse | Recruiting | Villejuif | France |
|
| Centre Hospitalier | Recruiting | Villeneuve-Saint-Georges | 94195 | France |
|
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C519688 | XELOX |
| D019370 | Observation |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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