Colectomy for Cancer in the Elderly by Laparoscopy or Laparotomy (CELL)

Multicenter Randomized Trial Comparing Laparoscopy and Laparotomy for Colon Cancer Surgery in Patients Older Than 75 Years

The purpose of this study is to compare the postoperative global morbidity between patients who have been operated on for a colon cancer by laparotomy and those operated on by laparoscopy

Study Overview

• Status: Unknown
• Conditions: Colonic Cancer
• Intervention / Treatment: Procedure: Laparotomy; Procedure: Laparoscopy

Detailed Description

The 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).

• Study Type: Interventional
• Enrollment (Anticipated): 276
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Groupe Hospitalier Pitié Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥ 75 years
2. Histologically proven colonic adenocarcinoma (> 15 cm from the anal margin) or precancerous colonic lesion non endoscopically resectable
3. 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)
4. No previous colonic cancer within the 5 last years
5. No peritoneal carcinosis on CT-scan
6. Patient able to fill in an auto-questionnaire alone or with some help
7. MMS (Mini Mental Score) ≥ 15
8. Given oral consent (formal informed consent is not required by French law for accepted procedures)

Exclusion Criteria:

1. Rectal cancer (≤ 15 cm from the anal margin)
2. Locally advanced (cT4) or complicated tumor requiring extended resection or emergency surgery
3. Synchronous colonic cancer
4. - Scheduled need for synchronous intra-abdominal surgery, including surgery for liver metastases
5. Absolute contraindications to general anesthesia or prolonged pneumoperitoneum
6. Patient not able to tolerate colon surgery according to the global comprehensive geriatric assessment
7. Estimated life expectancy less than 6 months
8. Patient under guardianship
9. Other known active cancer (except nonmelanomatous skin cancer)
10. Patient not affiliated to the social security system
11. Previous colonic resection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laparotomy; Open surgery	Procedure: Laparotomy; Open surgery; Other Names: Open surgery
Experimental: Laparoscopy; Minimally invasive surgery	Procedure: Laparoscopy; Minimally invasive surgery; Other Names: Minimally invasive surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global postoperative morbidity in both arms	Postoperative morbidity is defined as any surgical or medical complications occurring up to 30 days after surgery. It will be collected using a standardized collection form during hospitalization and eventual subsequent consultations in case of patient discharge before then	At 30 days after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative mortality	Death from any cause	Evaluated at 30 days and at 90 days after the surgery
Rate of readmission	Defined as any rehospitalization whatever the cause	Within the 30 days after discharge of the patient
Number of examined lymph nodes	Quality of surgical resection : Number of examined lymph nodes	At surgery
Type of resection (R0 or R1)	Quality of surgical resection : Type of resection (R0 or R1)	At surgery
Pathological evaluation of mesocolic resection quality	Quality of surgical resection : Pathological evaluation of mesocolic resection quality	At surgery
Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-C30)	Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-C30)	At randomization and three months postoperatively
Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29)	Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29)	At randomization and three months postoperatively
Mini Mental State (MMS) Examination or Folstein test	Evolution of geriatric scores : The Mini Mental State (MMS) Examination or Folstein test; (Comprehensive geriatric assessment performed by a geriatrician on each site)	Before randomization and three months postoperatively
Katz Activities of Daily Living (ADL) scale	Evolution of geriatric scores :The Katz Activities of Daily Living (ADL) scale (Comprehensive geriatric assessment performed by a geriatrician on each site)	Before randomization and three months postoperatively
Geriatric Depression Scale (GDS)	Evolution of geriatric scores :The Geriatric Depression Scale (GDS) (Comprehensive geriatric assessment performed by a geriatrician on each site)	Before randomization and three months postoperatively
Timed Get-up-and-go (TGUG)	Evolution of geriatric scores :The Timed Get-up-and-go (TGUG) test (Comprehensive geriatric assessment performed by a geriatrician on each site)	Before randomization and three months postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To establish a specific molecular classification of colon cancer in the elderly from expression chips	To establish a specific molecular classification of colon cancer in the elderly from expression chips (Ancillary studies will be conducted from formalin fixed paraffin embedded (FFPE) tumor samples from our cohort)	within the 15 years after the tumor sampling
To establish associations between molecular subtypes, the clinical and histological factors and relevant genetic alterations	To establish associations between molecular subtypes, the clinical and histological factors and relevant genetic alterations (Ancillary studies will be conducted from formalin fixed paraffin embedded (FFPE) tumor samples from our cohort)	within the 15 years after the tumor sampling
To establish a possible link between these molecular subtypes and overall survival of patients	To establish a possible link between these molecular subtypes and overall survival of patients. (Ancillary studies will be conducted from formalin fixed paraffin embedded (FFPE) tumor samples from our cohort)	within the 15 years after the tumor sampling
To compare our molecular classification with the different classifications already published in the literature on colorectal cance	To compare our molecular classification with the different classifications already published in the literature on colorectal cancer (Ancillary studies will be conducted from formalin fixed paraffin embedded (FFPE) tumor samples from our cohort)	within the 15 years after the tumor sampling

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Gilles MANCEAU, M.D., PhD.,, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Manceau G, Brouquet A, Chaibi P, Passot G, Bouche O, Mathonnet M, Regimbeau JM, Lo Dico R, Lefevre JH, Peschaud F, Facy O, Volpin E, Chouillard E, Beyert-Berjot L, Verny M, Karoui M, Benoist S. Multicenter phase III randomized trial comparing laparoscopy and laparotomy for colon cancer surgery in patients older than 75 years: the CELL study, a Federation de Recherche en Chirurgie (FRENCH) trial. BMC Cancer. 2019 Dec 4;19(1):1185. doi: 10.1186/s12885-019-6376-8.

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2017
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (Estimate): January 27, 2017

Study Record Updates

• Last Update Posted (Actual): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 11, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Morbidity; Elderly patients; Geriatrics; Colon cancer; Laparoscopy; Colorectal Surgery; Laparotomy; Digestive Oncology
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: K130901; 2016-A00312-49 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No