Actively Recruiting
Randomised Study Evaluating Adjuvant Chemotherapy After Resection of Stage III Colonic Adenocarcinoma in Patients of 70 and Over
Led by Federation Francophone de Cancerologie Digestive · Updated on 2024-07-08
774
Participants Needed
140
Research Sites
552 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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: * First, is there a benefit of fluoropyrimidine-based adjuvant chemotherapy for unfit elderly patients? * Second, is there a benefit of oxaliplatin-based adjuvant chemotherapy for fit elderly patients? The aim of this randomized phase III study is to evaluate the benefit for disease-free survival of adjuvant chemotherapy in elderly patient and which chemotherapy. 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.
CONDITIONS
Official Title
Randomised Study Evaluating Adjuvant Chemotherapy After Resection of Stage III Colonic Adenocarcinoma in Patients of 70 and Over
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 70 years or older
- Patient considered able to receive chemotherapy
- Lee score provided to CRGA
- Stage III colon adenocarcinoma
- Complete (R0) resection of primary tumor
- Adjuvant chemotherapy start within 12 weeks after surgery
- No prior chemotherapy for colon cancer
- Geriatric self-administered questionnaire submitted to CRGA
- Geriatric team questionnaire submitted to CRGA
- Effective contraception for men during treatment and for 6 months after oxaliplatin
- Signed informed consent
You will not qualify if you...
- Other progressive cancer uncontrolled for less than 2 years
- Rectal cancer located less than 15 cm from anal verge
- Absolute neutrophil count (ANC) below 2000/mm3 for group 1 or below 1500/mm3 for group 2
- Platelets below 100,000/mm3 or hemoglobin below 9 g/dL
- Neuropathy for group 1 patients
- Known deficiency of dihydropyrimidine dehydrogenase (DPD)
- Severe liver insufficiency
- Any contraindication to study drugs
- Inability to comply with medical follow-up due to geographic, social, or psychological reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 140 locations
1
CHU de Fort de France
Fort de France, Guadeloupe, France, 97261
Actively Recruiting
2
CH d'Abbeville
Abbeville, France, 80142
Actively Recruiting
3
CROMG
Agen, France
Actively Recruiting
4
Centre hospitalier du Pays d'Aix
Aix-en-Provence, France, 13616
Actively Recruiting
5
Centre hospitalier d'Albi
Albi, France, 81000
Actively Recruiting
6
Clinique Claude Bernard
Albi, France, 81030
Actively Recruiting
7
Clinique Claude Bernard
Albi, France
Actively Recruiting
8
Centre Oncogard
Alès, France, 30103
Actively Recruiting
9
Hôpital Sud
Amiens, France, 80054
Actively Recruiting
10
ICO Site Paul Papin
Angers, France, 49055
Actively Recruiting
11
CHU d'Angers
Angers, France, 49933
Actively Recruiting
12
HOP Privé
Annemasse, France
Actively Recruiting
13
CH Victor Dupouy
Argenteuil, France, 95107
Actively Recruiting
14
Hôpital Les Bonnettes
Arras, France, 62012
Actively Recruiting
15
Hôpital Privé Bonnettes
Arras, France
Actively Recruiting
16
Centre Hospitalier Ardèche Méridionale
Aubenas, France, 07205
Actively Recruiting
17
CH D'Auxerre
Auxerre, France, 89000
Actively Recruiting
18
Hôpital Henri Duffaut
Avignon, France, 84902
Actively Recruiting
19
Institut Sainte Catherine
Avignon, France, 84918
Actively Recruiting
20
Hôpital de Bayeux
Bayeux, France, 14401
Actively Recruiting
21
Centre d'Oncologie et de Radiothérapie du Pays-Basque
Bayonne, France, 64100
Actively Recruiting
22
CH Côte Basque
Bayonne, France, 64109
Actively Recruiting
23
CH de Beauvais
Beauvais, France, 60021
Actively Recruiting
24
CH de Béziers
Béziers, France, 34525
Actively Recruiting
25
CH de Blois
Blois, France, 41000
Actively Recruiting
26
CHU Avicenne
Bobigny, France, 93009
Actively Recruiting
27
Polyclinique Bordeaux Nord
Bordeaux, France, 33077
Actively Recruiting
28
Hôpital Duchenne
Boulogne-sur-Mer, France, 62321
Actively Recruiting
29
Hôpital Pierre Oudot
Bourgoin, France, 38300
Actively Recruiting
30
Clinique Pasteur Saint Esprit
Brest, France, 29200
Actively Recruiting
31
CHU Côte de Nacre
Caen, France, 14033
Actively Recruiting
32
CH
Cahors, France
Actively Recruiting
33
Infirmerie Protestante de Lyon
Caluire-et-Cuire, France, 69300
Actively Recruiting
34
CH William Morey
Chalon-sur-Saône, France, 71100
Actively Recruiting
35
Hôpital Privé Sainte Marie
Chalon-sur-Saône, France, 71100
Actively Recruiting
36
Centre Hospitalier Métropole Savoie
Chambéry, France, 73011
Actively Recruiting
37
Centre Hospitalier Général
Châlons-en-Champagne, France, 51005
Actively Recruiting
38
Centre Hospitalier Public du Cotentin
Cherbourg, France, 50102
Actively Recruiting
39
CH
Cherbourg, France
Actively Recruiting
40
CHU Estaing
Clermont-Ferrand, France, 63003
Actively Recruiting
41
Hopitaux Civils de Colmar
Colmar, France, 68024
Actively Recruiting
42
Centre Hospitalier
Compiègne, France, 60321
Actively Recruiting
43
CH
Contamine-sur-Arve, France
Actively Recruiting
44
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, 91106
Actively Recruiting
45
Clinique des Cèdres
Cornebarrieu, France, 31700
Actively Recruiting
46
Clinique des Cèdres
Cornebarrieu, France
Actively Recruiting
47
Centre Hospitalier de Dax
Dax, France, 40107
Actively Recruiting
48
Service de médecine
Digne-les-Bains, France, 04000
Actively Recruiting
49
Institut de Cancérologie de Bourgogne - GRRECC
Dijon, France, 21000
Actively Recruiting
50
Centre Goerges François Leclerc
Dijon, France, 21079
Actively Recruiting
51
Hôpital François Mitterand
Dijon, France, 21079
Actively Recruiting
52
CHI Elbeuf-Louviers-Val de Reuil
Elbeuf, France, 76503
Actively Recruiting
53
Centre médical des Forcilles
Férolles-Attilly, France, 77150
Actively Recruiting
54
CH
Flers, France
Actively Recruiting
55
CHI de Fréjus Saint-Raphaël
Fréjus, France, 83600
Actively Recruiting
56
Centre Hospitalier
Gap, France, 05007
Actively Recruiting
57
Centre Hospitalier
Gonesse, France, 95500
Actively Recruiting
58
CH
Gonesse, France
Actively Recruiting
59
CHU de Grenoble - Hôpital A. Michallon
Grenoble, France, 38043
Actively Recruiting
60
CH Marne La Vallée-Jossigny
Jossigny, France, 77600
Actively Recruiting
61
CHD Vendée
La Roche-sur-Yon, France, 85925
Actively Recruiting
62
Groupe Hospitalier de la Rochelle Ré-Aunis
La Rochelle, France, 17019
Actively Recruiting
63
CH
Le Coudray, France
Actively Recruiting
64
CH du Mans
Le Mans, France, 72037
Actively Recruiting
65
Centre Oscar Lambret
Lille, France, 59037
Actively Recruiting
66
CHRU Hôpital Claude Huriez 4eme EST
Lille, France, 59037
Actively Recruiting
67
Clinique François Chénieux
Limoges, France, 87000
Actively Recruiting
68
CHU Dupuytren
Limoges, France, 87042
Actively Recruiting
69
CH
Longjumeau, France, 91164
Actively Recruiting
70
CHBS - Hôpital du Scorff
Lorient, France, 56322
Actively Recruiting
71
Clinique Mutualiste Eugène André
Lyon, France, 69003
Actively Recruiting
72
Hôpital Privé Jean Mermoz
Lyon, France, 69008
Actively Recruiting
73
Clinique de la Sauvegarde
Lyon, France, 69009
Actively Recruiting
74
CHU de Lyon - Croix Rousse
Lyon, France, 69317
Actively Recruiting
75
CH ST Joseph-ST Luc
Lyon, France, 69365
Actively Recruiting
76
Hôpital Edouard Herriot
Lyon, France, 69437
Actively Recruiting
77
Hôpital Européen Marseille
Marseille, France, 13331
Actively Recruiting
78
CHU La Timone
Marseille, France, 13385
Actively Recruiting
79
Hopital Nord
Marseille, France, 13915
Actively Recruiting
80
Centre Radiologie
Mâcon, France
Actively Recruiting
81
CH de Meaux
Meaux, France, 77100
Actively Recruiting
82
Hôpital Layne
Mont-de-Marsan, France, 40024
Actively Recruiting
83
Centre Hospitalier
Montélimar, France, 26216
Actively Recruiting
84
Hôpital Monod
Montivilliers, France, 76290
Actively Recruiting
85
Centre Hospitalier
Morlaix, France, 29672
Actively Recruiting
86
Centre Azuréen de Cancérologie
Mougins, France, 06250
Actively Recruiting
87
Hôpital Privé du Confluent SAS
Nantes, France, 44277
Actively Recruiting
88
Hôpital Américain de Paris
Neuilly-sur-Seine, France, 92200
Actively Recruiting
89
Hôpital Pierre Bérégovoy
Nevers, France, 58033
Actively Recruiting
90
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
91
Centre Oncogard
Nîmes, France, 30029
Actively Recruiting
92
CHU Carémeau
Nîmes, France, 30029
Actively Recruiting
93
Hôpital de la Source
Orléans, France, 45067
Actively Recruiting
94
Hôpital Privé des Peupliers
Paris, France, 75013
Actively Recruiting
95
Hôpital Saint Antoine
Paris, France, 75571
Actively Recruiting
96
HEGP
Paris, France
Actively Recruiting
97
Hôpital Cochin
Paris, France
Actively Recruiting
98
Hôpital Saint Louis
Paris, France
Actively Recruiting
99
Institut Montsouris
Paris, France
Actively Recruiting
100
Pitié Salpêtière
Paris, France
Actively Recruiting
101
Centre Hospitalier
Pau, France, 64046
Actively Recruiting
102
Hôpital Haut Leveque
Pessac, France, 33604
Actively Recruiting
103
Polyclinique Francheville
Périgueux, France, 24004
Actively Recruiting
104
CHU Lyon Sud
Pierre-Bénite, France, 64495
Actively Recruiting
105
Centre CARIO - HCPA
Plérin, France, 22190
Actively Recruiting
106
Hôpital de la Milétrie
Poitiers, France, 86021
Actively Recruiting
107
CH Annecy Genevois
Pringy, France, 74374
Actively Recruiting
108
CHU Robert Debré
Reims, France, 51092
Actively Recruiting
109
CHU de Pontchaillou
Rennes, France, 35033
Actively Recruiting
110
Centre Eugène Marquis
Rennes, France, 35042
Actively Recruiting
111
CH
Rodez, France
Actively Recruiting
112
Hôpital Drome Nord
Romans-sur-Isère, France, 26100
Actively Recruiting
113
CHU Charles Nicolle
Rouen, France, 76031
Actively Recruiting
114
Clinique Mathilde
Rouen, France, 76175
Actively Recruiting
115
Institut Curie
Saint-Cloud, France, 92210
Actively Recruiting
116
Hôpital Privé Saint Grégoire
Saint-Grégoire, France, 35768
Actively Recruiting
117
ICO - Site René Gauducheau
Saint-Herblain, France, 44805
Actively Recruiting
118
Polyclinique Côte Basque Sud
Saint-Jean-de-Luz, France, 64500
Actively Recruiting
119
Hôpital d'Instruction des Armées Begin
Saint-Mandé, France, 94163
Actively Recruiting
120
CH Région Saint Omer
Saint-Omer, France, 62505
Actively Recruiting
121
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, France, 42271
Actively Recruiting
122
Polyclinique Saint Claude
Saint-Quentin, France, 02100
Actively Recruiting
123
CH
Saint-Quentin, France
Actively Recruiting
124
CH Saintonge
Saintes, France, 17108
Actively Recruiting
125
CH Morlevat
Semur-en-Auxois, France, 21140
Actively Recruiting
126
CH
Senlis, France, 60309
Actively Recruiting
127
Centre Hospitalier
Sens, France, 89108
Actively Recruiting
128
Centre Hospitalier de Saint-Malo
St-Malo, France, 35403
Actively Recruiting
129
Clinique Sainte Anne
Strasbourg, France, 67000
Actively Recruiting
130
Centre Paul Strauss
Strasbourg, France, 67065
Actively Recruiting
131
Hôpitaux du Leman
Thonon-les-Bains, France, 74203
Actively Recruiting
132
Hôpital Sainte Musse
Toulon, France, 83000
Actively Recruiting
133
Hôpital Sainte Musse
Toulon, France, 83000
Actively Recruiting
134
Clinique Saint Jean du Languedoc
Toulouse, France, 31077
Actively Recruiting
135
Hôpitaux Trousseau
Tours, France, 37044
Actively Recruiting
136
Centre Hospitalier
Valenciennes, France, 59322
Actively Recruiting
137
CHU de Nancy-Bradois
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
138
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France, 54519
Actively Recruiting
139
Paul Brousse
Villejuif, France
Actively Recruiting
140
Centre Hospitalier
Villeneuve-Saint-Georges, France, 94195
Actively Recruiting
Research Team
M
Martina Schneider
CONTACT
J
Jaique Cario
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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