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History of Changes for Study: NCT03033719
Colectomy for Cancer in the Elderly by Laparoscopy or Laparotomy (CELL)
Latest version (submitted January 11, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 24, 2017 None (earliest Version on record)
2 March 21, 2017 Study Status
3 July 24, 2017 Recruitment Status, Study Status and Contacts/Locations
4 January 11, 2018 Recruitment Status and Study Status
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Study NCT03033719
Submitted Date:  January 24, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: K130901
Brief Title: Colectomy for Cancer in the Elderly by Laparoscopy or Laparotomy (CELL)
Official Title: Multicenter Randomized Trial Comparing Laparoscopy and Laparotomy for Colon Cancer Surgery in Patients Older Than 75 Years
Secondary IDs: 2016-A00312-49 [ID RCB]
Open or close this module Study Status
Record Verification: December 2016
Overall Status: Not yet recruiting
Study Start: February 2017
Primary Completion: April 2020 [Anticipated]
Study Completion: June 2020 [Anticipated]
First Submitted: January 10, 2017
First Submitted that
Met QC Criteria:
January 24, 2017
First Posted: January 27, 2017 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 24, 2017
Last Update Posted: January 27, 2017 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Assistance Publique - Hôpitaux de Paris
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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).
Open or close this module Conditions
Conditions: Colonic Cancer
Keywords: Colorectal Surgery
Geriatrics
Digestive Oncology
Colon cancer
Elderly patients
Laparoscopy
Laparotomy
Morbidity
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 276 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Global postoperative morbidity in both arms
[ Time Frame: At 30 days after the surgery ]

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:
1. Postoperative mortality
[ Time Frame: Evaluated at 30 days and at 90 days after the surgery ]

Death from any cause
2. Rate of readmission
[ Time Frame: Within the 30 days after discharge of the patient ]

Defined as any rehospitalization whatever the cause
3. Number of examined lymph nodes
[ Time Frame: At surgery ]

Quality of surgical resection : Number of examined lymph nodes
4. Type of resection (R0 or R1)
[ Time Frame: At surgery ]

Quality of surgical resection : Type of resection (R0 or R1)
5. Pathological evaluation of mesocolic resection quality
[ Time Frame: At surgery ]

Quality of surgical resection : Pathological evaluation of mesocolic resection quality
6. Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-C30)
[ Time Frame: At randomization and three months postoperatively ]

Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-C30)
7. Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29)
[ Time Frame: At randomization and three months postoperatively ]

Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29)
8. Mini Mental State (MMS) Examination or Folstein test
[ Time Frame: Before randomization and three months postoperatively ]

Evolution of geriatric scores : The Mini Mental State (MMS) Examination or Folstein test; (Comprehensive geriatric assessment performed by a geriatrician on each site)
9. Katz Activities of Daily Living (ADL) scale
[ Time Frame: Before randomization and three months postoperatively ]

Evolution of geriatric scores :The Katz Activities of Daily Living (ADL) scale (Comprehensive geriatric assessment performed by a geriatrician on each site)
10. Geriatric Depression Scale (GDS)
[ Time Frame: Before randomization and three months postoperatively ]

Evolution of geriatric scores :The Geriatric Depression Scale (GDS) (Comprehensive geriatric assessment performed by a geriatrician on each site)
11. Timed Get-up-and-go (TGUG)
[ Time Frame: Before randomization and three months postoperatively ]

Evolution of geriatric scores :The Timed Get-up-and-go (TGUG) test (Comprehensive geriatric assessment performed by a geriatrician on each site)
Other Outcome Measures:
1. To establish a specific molecular classification of colon cancer in the elderly from expression chips
[ Time Frame: within the 15 years after the tumor sampling ]

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)
2. To establish associations between molecular subtypes, the clinical and histological factors and relevant genetic alterations
[ Time Frame: within the 15 years after the tumor sampling ]

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)
3. To establish a possible link between these molecular subtypes and overall survival of patients
[ Time Frame: within the 15 years after the tumor sampling ]

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)

4. To compare our molecular classification with the different classifications already published in the literature on colorectal cance
[ Time Frame: within the 15 years after the tumor sampling ]

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)
Open or close this module Eligibility
Minimum Age: 75 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Gilles MANCEAU, M.D., PhD.,
Telephone: 00331 42 17 56 51
Email: gilles.manceau@aphp.fr
Study Officials: Gilles MANCEAU, M.D., PhD.,
Principal Investigator
Assistance Publique - Hôpitaux de Paris
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:

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