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

• ClinicalTrials.gov Identifier: NCT03033719
• Recruitment Status: Recruiting
• First Posted: January 27, 2017
• Last Update Posted: January 12, 2018
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Tracking Information

• First Submitted Date: January 10, 2017
• First Posted Date: January 27, 2017
• Last Update Posted Date: January 12, 2018
• Actual Study Start Date: July 4, 2017
• Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 24, 2017)

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

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03033719 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: January 24, 2017)

• Postoperative mortality [ Time Frame: Evaluated at 30 days and at 90 days after the surgery ]
  Death from any cause
• Rate of readmission [ Time Frame: Within the 30 days after discharge of the patient ]
  Defined as any rehospitalization whatever the cause
• Number of examined lymph nodes [ Time Frame: At surgery ]
  Quality of surgical resection : Number of examined lymph nodes
• Type of resection (R0 or R1) [ Time Frame: At surgery ]
  Quality of surgical resection : Type of resection (R0 or R1)
• Pathological evaluation of mesocolic resection quality [ Time Frame: At surgery ]
  Quality of surgical resection : Pathological evaluation of mesocolic resection quality
• 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)
• 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)
• 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)
• 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)
• 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)
• 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)

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: January 24, 2017)

• 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)
• 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)
• 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)
• 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)

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Colectomy for Cancer in the Elderly by Laparoscopy or Laparotomy
• Official Title: Multicenter Randomized Trial Comparing Laparoscopy and Laparotomy for Colon Cancer Surgery in Patients Older Than 75 Years
• 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).
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Colonic Cancer

Intervention

• Procedure: Laparotomy
  Open surgery
  Other Name: Open surgery
• Procedure: Laparoscopy
  Minimally invasive surgery
  Other Name: Minimally invasive surgery

Study Arms

• Active Comparator: Laparotomy
  Open surgery
  Intervention: Procedure: Laparotomy
• Experimental: Laparoscopy
  Minimally invasive surgery
  Intervention: Procedure: Laparoscopy

• Publications *: Manceau G, Brouquet A, Chaibi P, Passot G, Bouché O, Mathonnet M, Regimbeau JM, Lo Dico R, Lefèvre 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 Fédération de Recherche en Chirurgie (FRENCH) trial. BMC Cancer. 2019 Dec 4;19(1):1185. doi: 10.1186/s12885-019-6376-8.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 24, 2017): 276
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2020
• Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 75 Years and older (Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Gilles MANCEAU, M.D., PhD.,; 00331 42 17 56 51; gilles.manceau@aphp.fr

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT03033719
• Other Study ID Numbers: K130901; 2016-A00312-49 ( Other Identifier: ID RCB )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Not Provided

Investigators

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

• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: January 2018