Back to resultsColectomy for Cancer in the Elderly by Laparoscopy or Laparotomy (CELL)
Primary Purpose
Colonic Cancer
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Laparotomy
Laparoscopy
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Cancer focused on measuring Colorectal Surgery, Geriatrics, Digestive Oncology, Colon cancer, Elderly patients, Laparoscopy, Laparotomy, Morbidity
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Groupe Hospitalier Pitié SalpêtrièreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Laparotomy
Laparoscopy
Arm Description
Open surgery
Minimally invasive surgery
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Postoperative mortality
Death from any cause
Rate of readmission
Defined as any rehospitalization whatever the cause
Number of examined lymph nodes
Quality of surgical resection : Number of examined lymph nodes
Type of resection (R0 or R1)
Quality of surgical resection : Type of resection (R0 or R1)
Pathological evaluation of mesocolic resection quality
Quality of surgical resection : Pathological evaluation of mesocolic resection quality
Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-C30)
Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-C30)
Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29)
Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29)
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)
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)
Geriatric Depression Scale (GDS)
Evolution of geriatric scores :The Geriatric Depression Scale (GDS) (Comprehensive geriatric assessment performed by a geriatrician on each site)
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)
Full Information
NCT ID
NCT03033719
First Posted
January 10, 2017
Last Updated
January 11, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03033719
Brief Title
Colectomy for Cancer in the Elderly by Laparoscopy or Laparotomy
Acronym
CELL
Official Title
Multicenter Randomized Trial Comparing Laparoscopy and Laparotomy for Colon Cancer Surgery in Patients Older Than 75 Years
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 4, 2017 (Actual)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Cancer
Keywords
Colorectal Surgery, Geriatrics, Digestive Oncology, Colon cancer, Elderly patients, Laparoscopy, Laparotomy, Morbidity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
276 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laparotomy
Arm Type
Active Comparator
Arm Description
Open surgery
Arm Title
Laparoscopy
Arm Type
Experimental
Arm Description
Minimally invasive surgery
Intervention Type
Procedure
Intervention Name(s)
Laparotomy
Other Intervention Name(s)
Open surgery
Intervention Description
Open surgery
Intervention Type
Procedure
Intervention Name(s)
Laparoscopy
Other Intervention Name(s)
Minimally invasive surgery
Intervention Description
Minimally invasive surgery
Primary Outcome Measure Information:
Title
Global postoperative morbidity in both arms
Description
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
Time Frame
At 30 days after the surgery
Secondary Outcome Measure Information:
Title
Postoperative mortality
Description
Death from any cause
Time Frame
Evaluated at 30 days and at 90 days after the surgery
Title
Rate of readmission
Description
Defined as any rehospitalization whatever the cause
Time Frame
Within the 30 days after discharge of the patient
Title
Number of examined lymph nodes
Description
Quality of surgical resection : Number of examined lymph nodes
Time Frame
At surgery
Title
Type of resection (R0 or R1)
Description
Quality of surgical resection : Type of resection (R0 or R1)
Time Frame
At surgery
Title
Pathological evaluation of mesocolic resection quality
Description
Quality of surgical resection : Pathological evaluation of mesocolic resection quality
Time Frame
At surgery
Title
Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-C30)
Description
Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-C30)
Time Frame
At randomization and three months postoperatively
Title
Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29)
Description
Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29)
Time Frame
At randomization and three months postoperatively
Title
Mini Mental State (MMS) Examination or Folstein test
Description
Evolution of geriatric scores : The Mini Mental State (MMS) Examination or Folstein test; (Comprehensive geriatric assessment performed by a geriatrician on each site)
Time Frame
Before randomization and three months postoperatively
Title
Katz Activities of Daily Living (ADL) scale
Description
Evolution of geriatric scores :The Katz Activities of Daily Living (ADL) scale (Comprehensive geriatric assessment performed by a geriatrician on each site)
Time Frame
Before randomization and three months postoperatively
Title
Geriatric Depression Scale (GDS)
Description
Evolution of geriatric scores :The Geriatric Depression Scale (GDS) (Comprehensive geriatric assessment performed by a geriatrician on each site)
Time Frame
Before randomization and three months postoperatively
Title
Timed Get-up-and-go (TGUG)
Description
Evolution of geriatric scores :The Timed Get-up-and-go (TGUG) test (Comprehensive geriatric assessment performed by a geriatrician on each site)
Time Frame
Before randomization and three months postoperatively
Other Pre-specified Outcome Measures:
Title
To establish a specific molecular classification of colon cancer in the elderly from expression chips
Description
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)
Time Frame
within the 15 years after the tumor sampling
Title
To establish associations between molecular subtypes, the clinical and histological factors and relevant genetic alterations
Description
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)
Time Frame
within the 15 years after the tumor sampling
Title
To establish a possible link between these molecular subtypes and overall survival of patients
Description
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)
Time Frame
within the 15 years after the tumor sampling
Title
To compare our molecular classification with the different classifications already published in the literature on colorectal cance
Description
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)
Time Frame
within the 15 years after the tumor sampling
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gilles MANCEAU, M.D., PhD.,
Phone
00331 42 17 56 51
Email
gilles.manceau@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles MANCEAU, M.D., PhD.,
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles MANCEAU, MD
Email
gilles.manceau@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31801485
Citation
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.
Results Reference
derived
Learn more about this trial
Colectomy for Cancer in the Elderly by Laparoscopy or Laparotomy
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