Etude : CELL /



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : CELL

Nom :

Traitement :

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 25/09/2018
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Multicenter Randomized Trial Comparing Laparoscopy and Laparotomy for Colon Cancer Surgery in Patients Older Than 75 Years

Spécialité : Organes digestifs
Localisation : C18 - Tumeur maligne du côlon
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : he present study is a national, multicenter, open-label randomized, 2-arm superiority trial. Patients aged 75 years or older with uncomplicated colonic cancer or precancerous colonic lesion non-endoscopically resectable, will be randomized to either colectomy by laparoscopy or laparotomy. All patients that might be included will have a comprehensive geriatric assessment performed within the 30 days before randomization with the following scores: MMS (Mini Mental Score), ADL scale (Activities of Daily Living), IADL scale (Instrumental Activities of Daily Living), GDS (Geriatric Depression Scale) and TGUG test ("Timed Get-Up-and-Go" test).

Phase : NA

Stade : NA

NA
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion :
Age ≥ 75 years
Histologically proven colonic adenocarcinoma (> 15 cm from the anal margin) or precancerous colonic lesion non endoscopically resectable
Uncomplicated colonic tumor (no preoperative suspicion of invasion of adjacent structures as assessed by CT-scan (cT4), no tumoral perforation, or tumoral obstruction, or abscess, or hemorrhage)
No previous colonic cancer within the 5 last years
No peritoneal carcinosis on CT-scan
Patient able to fill in an auto-questionnaire alone or with some help
MMS (Mini Mental Score) ≥ 15
Given oral consent (formal informed consent is not required by French law for accepted procedures)

Critères de non-inclusion :
Rectal cancer (≤ 15 cm from the anal margin)
Locally advanced (cT4) or complicated tumor requiring extended resection or emergency surgery
Synchronous colonic cancer
- Scheduled need for synchronous intra-abdominal surgery, including surgery for liver metastases
Absolute contraindications to general anesthesia or prolonged pneumoperitoneum
Patient not able to tolerate colon surgery according to the global comprehensive geriatric assessment
Estimated life expectancy less than 6 months
Patient under guardianship
Other known active cancer (except nonmelanomatous skin cancer)
Patient not affiliated to the social security system
Previous colonic resection
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
Promoteur :
APHP
Type de sponsor : Institutionnel
75010 PARIS 10

Coordonnateur :
Gilles MANCEAU
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
CHU de Rouen - 1 Rue de Germont - 76000 ROUEN

Investigateur :
Valérie BRIDOUX

TEC / ARC / IDE :
Nathalie BREDA
nathalie.breda@
chu-rouen.fr

Ouverture de l'essai : OUVERT

MAJ : 25/09/2018