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Trial record 1 of 9 for:    cell+colon+75 | Recruiting Studies
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Colectomy for Cancer in the Elderly by Laparoscopy or Laparotomy (CELL)

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

Tracking Information
First Submitted Date  ICMJE January 10, 2017
First Posted Date  ICMJE January 27, 2017
Last Update Posted Date January 12, 2018
Actual Study Start Date  ICMJE July 4, 2017
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT03033719 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE 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  ICMJE Colectomy for Cancer in the Elderly by Laparoscopy or Laparotomy
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colonic Cancer
Intervention  ICMJE
  • Procedure: Laparotomy
    Open surgery
    Other Name: Open surgery
  • Procedure: Laparoscopy
    Minimally invasive surgery
    Other Name: Minimally invasive surgery
Study Arms  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 24, 2017)
276
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 75 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gilles MANCEAU, M.D., PhD., 00331 42 17 56 51 gilles.manceau@aphp.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03033719
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gilles MANCEAU, M.D., PhD., Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP